Abstract
Background
Deep caries in primary molars threatens pulpal health, and treatment choices should balance infection control with tooth retention. This retrospective cohort study described 12-month outcomes of primary molar pulpotomy using iRoot BP Plus (BP), while calcium hydroxide [Ca(OH)2]-treated teeth were described only as a non-comparable institutional context. Potential BP-group outcome indicators were explored in a hypothesis-generating manner.
Methods
Children aged 3–10 years who received pulpotomy between September 2022 and January 2025 were included if baseline and treatment records were complete, with the tooth as the analytic unit. The 12-month outcome analysis was restricted to teeth with evaluable follow-up records within a 10–14-month window. Biological success was adjudicated from clinical follow-up records and available radiographs within the 10–14-month window; radiographic assessment was not available for all evaluable teeth. Restoration complications were assessed only among biologically successful teeth. Within BP-treated teeth, preoperative symptoms, hemostasis time (<1 vs. ≥1 min), and pulp exposure size were summarized descriptively as exploratory indicators. A three-item cumulative indicator count was described as hypothesis-generating only.
Results
Sixty-seven children contributed 122 primary molars [BP, 81; Ca(OH)2, 41]. At 12 months, 109/122 teeth were evaluable [BP, 80/81; Ca(OH)2, 29/41], and 107/109 had radiographs. Among evaluable BP-treated teeth, biological success was 95.0% (76/80), with 2/80 adjudicated clinically only. Restoration complications occurred in 3.9% of biologically successful BP-treated teeth (3/76). Ca(OH)2-treated teeth showed 100.0% biological success among evaluable teeth (29/29), but this estimate was limited by non-randomized allocation, baseline imbalance, and lower follow-up completeness. Within BP-treated teeth, the four biological failures were descriptively observed in teeth with documented symptoms, longer hemostasis time, and larger pulp exposure size.
Conclusions
Among evaluable BP-treated teeth, the observed 12-month biological success proportion was 95.0% within guideline-based indications. The BP-group indicator patterns were descriptive and hypothesis-generating, and require external validation.
Keywords: Primary molars, pulpotomy, iRoot BP Plus, pulp exposure, exploratory outcome indicators
Highlight box.
Key findings
• In this single-center retrospective real-world cohort, evaluable iRoot BP Plus-treated primary molars had an observed 12-month biological success proportion of 95.0% (76/80). Restoration-related complications occurred in 3.9% (3/76) of biologically successful BP-treated teeth.
• The four BP-group biological failures were descriptively observed in teeth with documented preoperative symptoms, hemostasis time ≥1 min, and larger pulp exposure size; these observations are descriptive and hypothesis-generating only.
What is known and what is new?
• Calcium silicate-based materials are recommended for vital pulp therapy in caries-affected vital primary teeth, but real-world data for premixed iRoot BP Plus and chairside risk signals remain limited.
• This study adds 12-month real-world outcome data for BP pulpotomy, separates biological failure from restoration-related complications, and describes routinely recorded symptom, hemostasis, and exposure-size patterns in the few observed failure cases.
What is the implication, and what should change now?
• BP can be further evaluated as a pulpotomy medicament within guideline-based indications. Clinicians should not use the exploratory indicators as validated criteria for treatment selection or follow-up scheduling.
• Prospective multicentre studies should standardize symptom classification, hemostasis recording, exposure measurement, coronal seal assessment, and restorative strategy.
Introduction
Dental caries remains among the most prevalent chronic diseases affecting children worldwide, and early childhood caries (ECC) can adversely affect children’s oral function, comfort, and quality of life (1). In routine practice, an untreated primary molar may cause pain, sleep disturbance, missed school or childcare, and urgent dental visits, thereby contributing to family and health-system burden (2,3). These downstream impacts align with Global Burden of Disease analyses showing that oral conditions impose sustained functional losses at the population level, with childhood caries remaining a persistent public health priority (4).
Clinically, ECC and other deep carious lesions often converge into the same decision point: how to preserve pulp vitality in a primary molar with deep caries approaching the pulp or with caries-related exposure, while preventing infection and maintaining the tooth until physiologic exfoliation (5-7). Vital pulp therapy (VPT) includes indirect pulp treatment, direct pulp capping, and pulpotomy. Pulpotomy remains widely used in primary molars because it follows a relatively standardized pathway and is feasible across outpatient clinics and, when needed, under general anesthesia or sedation (8,9). However, evidence syntheses have highlighted heterogeneity across primary-tooth pulp-therapy studies, including indications, procedural details, endpoint definitions, and follow-up windows, limiting comparability and external validity. This challenge is amplified by primary-tooth biology, including physiologic root resorption and furcation anatomy, and by the proximity of the succedaneous tooth germ, which raises the clinical stakes of both overt failure and radiographic pathology.
Materials have evolved alongside the biological rationale for VPT. Calcium hydroxide [Ca(OH)2] was used extensively for pulp capping and pulpotomy, yet inconsistent outcomes and internal resorption have been repeatedly reported in primary molars (10). Calcium silicate cements, including mineral trioxide aggregate (MTA) and related formulations, have shifted the field toward bioactivity and more reliable sealing. Long-term clinical studies and network evidence have generally supported higher and more consistent success with calcium silicate-based medicaments than with Ca(OH)2 in primary molar pulpotomy, while also highlighting ongoing variability in study designs and endpoints (11-13). Recent evidence-based guidance has therefore recommended calcium silicate cements as preferred VPT medicaments for caries-affected vital primary teeth.
Premixed bioceramics further aim to improve chairside usability. iRoot BP Plus (BP), a premixed calcium silicate-based bioceramic, has shown favorable pulp-cell interactions and mineralization-related responses in basic studies, and clinical reports in pulpotomy-related settings supported its feasibility relative to Ca(OH)2 (14,15). More recent retrospective studies of primary molars have reported favorable clinical and radiographic outcomes for BP pulpotomy in both outpatient and general-anesthesia settings, despite differences in hemostasis thresholds and follow-up schedules, underscoring the need for clinically interpretable intraoperative decision cues (16,17). In parallel, symptomatic primary molar pulpotomy has been explored with modern bioceramic materials in selected studies, but such evidence remains preliminary and should be interpreted within guideline-based indications (18).
Despite these advances, two gaps remain particularly relevant to day-to-day decision-making. One gap concerns the interpretation of potential outcome-related indicators observed during routine care. Failures may reflect preoperative inflammatory burden and the intraoperative ability to achieve adequate inflammation control. Nevertheless, clinicians often record immediately observable variables, such as symptom profile, hemostasis characteristics, and pulp exposure features, but the descriptive value of these variables in BP-treated primary molars remains insufficiently characterized (5,6,19). The other gap concerns endpoint attribution. In pediatric dentistry, reinfection risk is strongly shaped by coronal seal quality and restorative strategy, and multi-surface lesions make margin control difficult. Restoration breakdown, microleakage, or secondary caries may therefore confound follow-up assessments if they are grouped indiscriminately as VPT failure (20). Evidence on primary molars also indicates that definitive restoration, particularly a stainless steel crown (SSC), meaningfully influences survival, underscoring coronal sealing as a modifiable lever for long-term stability (21). These gaps intersect because preoperative and intraoperative findings may help explain variation in biological outcomes while also highlighting the importance of coronal seal quality in routine care.
Against this background, we examined 12-month outcomes of primary molar pulpotomy under routine clinical conditions, with BP-treated teeth as the main analytic focus. Because Ca(OH)2 was also used in the same institution during the study period, Ca(OH)2-treated teeth were described only as a non-comparable institutional context rather than as a contemporary benchmark, randomized control, or balanced comparative-efficacy cohort. The primary aim was to characterize BP outcomes and describe potential BP-group outcome indicators based on preoperative and intraoperative variables. We hypothesized that intraoperative inflammation-control variables, particularly hemostasis time and pulp exposure size, might show descriptive patterns among BP-treated teeth with biological failure. The remainder of this paper describes the study design and outcome definitions, presents material-group outcomes and BP-specific exploratory analyses with imaging exemplars, and discusses the findings in the context of contemporary pediatric VPT evidence. We present this article in accordance with the STROBE reporting checklist (available at https://tp.amegroups.com/article/view/10.21037/tp-2026-0649/rc).
Methods
Study design and ethics
This study was designed as a single-center, retrospective, real-world follow-up investigation. Data were obtained from the Department of Pediatric Stomatology at Nantong Stomatological Hospital and comprised complete medical records, including follow-up documentation, for both outpatient and general anesthesia/sedation cases. Treatments were performed by 4 pediatric dentists with clinical experience in primary molar VPT. Eligible cases were identified from treatments performed between September 2022 and January 2025, and follow-up records were retrieved through January 2026. The tooth was used as the unit of analysis; in parallel, basic demographic information and the number of included teeth were recorded at the patient level. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study protocol was approved by the Ethics Committee of Nantong Stomatological Hospital (approval No. PJ2026-010-01). Given the retrospective design, the ethics committee waived the requirement for individual informed consent.
Children aged 3–10 years who underwent pulpotomy in a primary first or second molar were eligible for inclusion if the pulpotomy medicament was BP or calcium hydroxide and baseline treatment records were complete. The overall retrospective cohort included eligible treated teeth regardless of whether 12-month outcome data were available. Teeth were included in the 12-month primary outcome analysis only when at least one clinical follow-up record was available within the 10–14-month window, enabling biological success/failure to be adjudicated. Teeth were excluded if they were deemed non-restorable or required immediate extraction based on preoperative/intraoperative findings, if the case did not meet pulpotomy indications, or if the case was converted to another treatment modality with outcomes not reliably traceable.
Participants were assigned to the BP or calcium hydroxide group based on the pulpotomy medicament used. Pulpotomy was conducted according to routine clinical procedures, including local anesthesia, caries removal, access opening, coronal pulp amputation to the level of the canal orifices when complete coronal pulpotomy was performed, hemostasis, placement of the pulpotomy medicament, and final restoration. The isolation method and final restoration category were extracted from clinical records when available. In the structured retrospective records, final restoration was reliably extractable as SSC versus non-SSC restoration; however, the specific material, surface coverage, marginal quality, and detailed design of non-SSC restorations were not consistently documented and therefore could not be subclassified. Rubber dam use was not consistently documented in the retrospective records. To reduce confounding between material-related and restoration-related factors, biological outcomes and restorative complications were defined and evaluated separately in the outcome assessment. The medications used were BP (Innovative Bioceramix, Inc., Vancouver, Canada) and calcium hydroxide (Calcimol LC, Voco GmbH, Cuxhaven, Germany). Ca(OH)2-treated teeth were described only as a non-comparable institutional context from the same institution and study period. During the earlier Ca(OH)2 treatment period, hemostasis time, pulp exposure size, extent of coronal pulp removal, and restorative details were not captured using standardized structured fields; therefore, these variables could not be reliably extracted for the Ca(OH)2 cohort. Because treatment allocation was non-randomized, baseline characteristics differed between groups, and follow-up completeness was unequal, the study was not designed or powered to establish comparative efficacy between BP and Ca(OH)2. For the purpose of cohort eligibility, cases documented as direct pulp capping without coronal pulp amputation were not classified as pulpotomy cases. When the extent of coronal pulp removal was available in the records, it was recorded as complete or partial coronal pulp removal and reported descriptively.
Variable definitions and data sources
Data were extracted from electronic medical records, the institutional imaging system, and standardized follow-up forms. The dataset included both patient-level and tooth-level information. Patient-level variables comprised sex and age at the time of treatment (calculated from the treatment date). Tooth-level variables included tooth type (primary first molar/primary second molar), cavity type (e.g., mesio-/disto-occlusal involvement, categorized according to the clinical record), preoperative symptoms, hemostasis time, pulp exposure size, and whether an SSC restoration was performed.
Preoperative symptoms: Teeth were classified as ‘symptomatic’ when at least one preoperative complaint or sign was documented in the clinical record, including spontaneous pain, nocturnal pain, pain on chewing/percussion, thermal pain, gingival swelling, or sinus tract. This variable was used as a broad chart-derived clinical risk marker and should not be interpreted as a diagnosis of irreversible pulpitis. Teeth without these records were categorized as ‘asymptomatic/no discomfort.’
Hemostasis time: Hemostasis time was defined as the interval from the initiation of hemostatic management after coronal pulp amputation to the achievement of clinically acceptable hemostasis, namely the absence of persistent bleeding from the pulpal floor under pressure with a dry cotton pellet and the formation of a stable blood clot, as recorded in the medical chart. To support exploratory analysis, hemostasis time was categorized as <1 versus ≥1 min. The 1-min threshold was selected pragmatically before analysis to capture an early delay in hemostatic control based on the categories available in the clinical records. It was not derived from data-driven threshold optimization, external validation, or guideline-based indication criteria and should not be interpreted as replacing the conventional clinical requirement that hemostasis be achievable within an acceptable time window, commonly within 5 min.
Pulp exposure size was extracted from intraoperative measurements documented in millimeters (mm). When multiple measurements were recorded for the same tooth, the largest value was used for analysis to reflect the maximum exposure noted intraoperatively. Pulp exposure size was first analyzed as a continuous variable. In the BP-group exploratory cumulative indicator count, a pulp exposure size >1 mm was used as a pragmatic descriptive item; this cutoff was not derived from data-driven optimization, external validation, or an established clinical decision threshold. The retrospective records documented exposure size in millimeters, but the specific measurement method, such as periodontal probe measurement versus visual estimation, was not consistently recorded. No inter- or intra-operator reliability data were available for exposure-size measurement because this was a retrospective study based on routine clinical records.
Follow-up and outcome definitions
For the primary analysis, the “12-month outcome” was determined using follow-up documentation obtained around postoperative month 12, with an allowable assessment window of 10–14 months after treatment. When multiple records for the same tooth were available within this window, the record closest to the 12-month time point was selected for outcome determination. If a tooth had a clinical follow-up record within the window but lacked a contemporaneous radiographic record, it was included in the clinical outcome assessment but excluded from the radiographic component of the coded-outcome consistency check; in such cases, radiographic outcomes were based on the most recent radiograph available within the 10–14-month window. A tooth was considered “evaluable at 12 months” if at least one clinical follow-up record was present within the 10–14-month window. For radiographic outcomes, evaluability additionally required corresponding radiographic data within the same window; as a result, the denominator for radiographic outcomes could be smaller than that for clinical outcomes.
The primary endpoint was 12-month biological success, adjudicated using clinical follow-up records and available radiographic information within the assessment window. Biological success required the absence of infection-related clinical signs or symptoms (e.g., abscess, sinus tract, persistent pain, marked percussion tenderness/swelling) and, when radiographs were available within the assessment window, the absence of pathological radiographic findings (e.g., furcal/periapical radiolucency, pathological root resorption). Teeth without radiographs in the 10–14-month window were retained in the integrated biological outcome analysis only when clinical follow-up records allowed adjudication; these teeth were reported as clinically adjudicated only. If a tooth was extracted within the follow-up window for reasons related to physiological exfoliation or eruption of the succedaneous tooth, and this reason was clearly documented, the case was not classified as a biological failure (i.e., handled as censored/non-failure). Outcome adjudication was performed independently by two pediatric dentists; disagreements were resolved by discussion, with adjudication by a third dentist when required.
The secondary endpoint was restorative complications among biologically successful teeth. To avoid conflating restorative problems with pulpotomy failure, restorative complications were counted only for teeth classified as biologically successful. Restorative complications included, but were not limited to, restoration loss or fracture, marginal failure with obvious microleakage, or secondary caries requiring retreatment, as recorded in follow-up documentation.
To assess the consistency between investigator-adjudicated outcomes and predefined follow-up coding fields, a coded-outcome consistency check was conducted using the 12-month ‘clinical code’ and ‘radiographic code’ fields in the follow-up form. Notably, the primary endpoint was adjudicated by investigators through an integrated review of clinical records within the follow-up window, together with available radiographic information, and was therefore not fully dependent on completeness of the predefined coding fields. In contrast, the coded-outcome consistency check relied strictly on the predefined 12-month clinical and radiographic coding fields for statistical calculation. Accordingly, when some cases contained sufficient information for primary endpoint adjudication but lacked corresponding radiographic coding entries, the denominator for the radiographic coding-based coded-outcome consistency check could be smaller than that used in the primary endpoint analysis. To examine the potential influence of differential attrition, a missing-data sensitivity scenario was added. In this conservative scenario, all teeth without a 12-month evaluable outcome in the Ca(OH)2 group were assumed to have experienced biological failure. This analysis was not intended to estimate the true failure rate but to illustrate the possible effect of missing follow-up data on interpretation of the Ca(OH)2 outcome.
Exploratory description of BP-group outcome indicators
To describe potential BP-group outcome indicators following BP pulpotomy, selected preoperative and intraoperative variables were summarized among evaluable BP-treated teeth at 12 months. These variables included preoperative symptom status, categorized hemostasis time, and measured pulp exposure size. A simple exploratory cumulative indicator count (0–3 points) was then described using three chairside-available variables: preoperative symptoms (symptomatic =1 point), hemostasis time ≥1 min (1 point), and pulp exposure size >1 mm (1 point). These cutoffs were pragmatic descriptive items rather than validated or statistically optimized thresholds. This indicator count was intended only as a hypothesis-generating proof-of-concept approach. Because only four biological failures occurred, it was not treated as a validated predictive model, and no multivariable model development or internal validation was attempted.
Statistical analysis
The study size was determined by the number of consecutive eligible teeth treated during the predefined study period and with retrievable baseline treatment records. No formal a priori sample size calculation was performed because this was a retrospective descriptive cohort study based on routine clinical records. The BP-group exploratory analyses were therefore interpreted as hypothesis-generating only. Continuous variables were summarized as the median [interquartile range (IQR)], whereas categorical variables were reported as frequency (%). Baseline characteristics and material-group outcomes were summarized descriptively. Because treatment allocation was non-randomized and follow-up completeness differed between groups, between-material statistical comparisons were not used to infer comparative efficacy. Proportions were summarized with 95% confidence intervals. For sparse BP-group exploratory analyses, absolute failure rates with exact binomial 95% confidence intervals were emphasized. Because of the small number of biological failures and the presence of zero-event cells, odds ratios for zero-cell comparisons, multivariable modeling, and cluster-adjusted modeling were not attempted. Formal hypothesis testing was not used to support clinical interpretation of the BP-group exploratory indicators, and P values were removed from the main exploratory tables and figures to avoid overinterpretation.
All analyses were performed in IBM SPSS Statistics 27.0 (IBM Corp., Armonk, NY, USA), with the tooth as the unit of analysis. Because some children contributed more than one tooth, outcomes may have been correlated within patients. Given the small number of biological failures, cluster-adjusted regression, generalized estimating equations (GEE), mixed-effects modeling, and multivariable prediction modeling were not considered reliable and were therefore not performed. No imputation was performed for the primary available-case analyses.
Results
Study cohort and baseline characteristics
A total of 67 children (39 boys and 28 girls), contributing 122 primary molars, were included and underwent pulpotomy. At the patient level, the overall median age at treatment was 5.76 years (IQR, 4.39–7.37 years). The median number of included teeth per child was 1 (range, 1–6), and the median observation period was 18 months (IQR, 14–25 months; range, 11–40 months). Tooth-level baseline characteristics and material-group allocation are summarized in Table 1. Among BP-treated teeth evaluable at 12 months, biological failure was observed in 1/43 teeth from boys and 3/37 teeth from girls. Among Ca(OH)2-treated teeth evaluable at 12 months, no biological failures were observed in teeth from boys (0/14) or girls (0/15). Because only four biological failures occurred, no sex-related inferential analysis was performed. NA indicates that the variable was not recorded or could not be extracted in that group. Missing values reflect the original routine clinical records. Hemostasis time was systematically extractable for BP-treated teeth but was not captured in standardized structured fields during the earlier Ca(OH)2 treatment period; therefore, it could not be reliably extracted for Ca(OH)2-treated teeth. Complete coronal pulp removal refers to removal of coronal pulp tissue to the level of the canal orifices. Partial coronal pulp removal was recorded only when explicitly documented in the operative record; cases documented as direct pulp capping were not classified as pulpotomy cases.
Table 1. Tooth-level characteristics and group allocation.
| Variable | Overall (n=122) | BP (n=81) | Calcium hydroxide (n=41) |
|---|---|---|---|
| Follow-up duration (months) | 18 [14–25] | 18 [14–23] | 19 [16–26] |
| Age at treatment (years) | 5.58 [4.20–6.86] | 5.58 [4.37–7.21] | 5.58 [3.94–6.52] |
| Arch | |||
| Maxilla | 55 (45.1) | 36 (44.4) | 19 (46.3) |
| Mandible | 67 (54.9) | 45 (55.6) | 22 (53.7) |
| Tooth type | |||
| Primary first molar | 63 (51.6) | 41 (50.6) | 22 (53.7) |
| Primary second molar | 59 (48.4) | 40 (49.4) | 19 (46.3) |
| Cavity location | |||
| Proximal-occlusal | 73 (59.8) | 45 (55.6) | 28 (68.3) |
| Proximal only | 24 (19.7) | 16 (19.8) | 8 (19.5) |
| Occlusal only | 25 (20.5) | 20 (24.7) | 5 (12.2) |
| Preoperative symptoms | |||
| Asymptomatic | 64 (52.5) | 32 (39.5) | 32 (78.0) |
| Symptomatic | 58 (47.5) | 49 (60.5) | 9 (22.0) |
| Pulp exposure size (mm) | 1.0 [1.0–2.0] | 1.0 [1.0–2.0] | NA |
| Hemostasis time | |||
| <1 min | 61 (50.0) | 61 (75.3) | – |
| 1–3 min | 19 (15.6) | 19 (23.5) | – |
| >5 min | 1 (0.8) | 1 (1.2) | – |
| Missing | 41 (33.6) | – | 41 (100.0) |
| Extent of coronal pulp removal | |||
| Partial | 23 (18.9) | 23 (28.4) | – |
| Complete | 57 (46.7) | 57 (70.4) | – |
| Missing | 42 (34.4) | 1 (1.2) | 41 (100.0) |
| Final restoration category in structured records | |||
| SSC restoration | 13 (10.7) | 13 (16.0) | – |
| Non-SSC restoration | 80 (65.6) | 68 (84.0) | 12 (29.3) |
| Missing | 29 (23.8) | – | 29 (70.7) |
| Evaluable for primary outcome at 12 months | 109 (89.3) | 80 (98.8) | 29 (70.7) |
Data are presented as median [interquartile range] or n (%). BP, iRoot BP Plus; NA, not available; SSC, stainless steel crown.
By material group, 81 teeth were assigned to the BP group and 41 teeth to the calcium hydroxide group. The distribution of tooth type appeared descriptively similar across groups, with similar proportions of primary first and primary second molars. Proximal-occlusal involvement was the most common cavity pattern, representing 59.8% of teeth overall. Within the BP group, 60.5% of teeth were symptomatic preoperatively, the median pulp exposure size was 1.0 mm (IQR, 1.0–2.0 mm), and hemostasis was achieved within <1 min in most cases (75.3%). Regarding definitive restoration, 13/81 BP-treated teeth (16.0%) received SSC restoration, whereas 68/81 teeth (84.0%) were recorded as non-SSC restorations; the specific non-SSC restorative materials or restoration designs were not reliably subclassified in the structured records. Overall, 89.3% (109/122) were evaluable at 12 months, including 98.8% (80/81) in the BP group and 70.7% (29/41) in the calcium hydroxide group. For several non-evaluable teeth, the reason for missing 12-month follow-up could not be reliably determined from the retrospective records. This lack of information was therefore considered an additional source of attrition-related uncertainty.
Twelve-month outcomes by material group
The primary outcome was 12-month biological success, defined as the absence of infection-related clinical signs and pathological radiographic changes at follow-up; teeth extracted for clearly documented physiological exfoliation or eruption of the succedaneous permanent tooth were not counted as failures. Primary and secondary outcomes at 12 months are summarized in Table 2. 95% confidence intervals (CIs) were calculated using the Wilson method. Biological success was adjudicated using clinical follow-up records and available radiographs within the 10–14-month window. Restorative complications were defined as restoration-related problems requiring repair/replacement among biologically successful teeth without biological failure. Because of non-randomized treatment allocation, baseline imbalance, and differential follow-up completeness, between-material statistical comparisons were not used to infer comparative efficacy.
Table 2. Outcomes at 12 months.
| Outcome | BP | Calcium hydroxide |
|---|---|---|
| Evaluable teeth for integrated biological outcome at 12 months (N) | 80 | 29 |
| Radiographic assessment available within 10–14-month window | 78/80 (97.5) | 29/29 (100.0) |
| Clinical-only adjudication | 2/80 (2.5) | 0/29 (0.0) |
| Primary endpoint | ||
| Biological success | 76/80 (95.0); 95% CI: 87.8–98.0 | 29/29 (100.0); 95% CI: 88.3–100.0 |
| Biological failure | 4/80 (5.0) | 0/29 (0.0) |
| Secondary endpoint | ||
| Restorative complications (among biologically successful teeth) | 3/76 (3.9); 95% CI: 1.4–11.0 | 2/29 (6.9); 95% CI: 1.9–22.0 |
| Coded-outcome consistency check | ||
| Clinical coded success (code12 =0) | 73/80 (91.2) | 27/29 (93.1) |
| Radiographic coded success (codeX12 =0) | 74/78 (94.9) | 29/29 (100.0) |
Data are presented as n/N (%) unless otherwise specified. Integrated biological success was adjudicated using clinical follow-up records and available radiographs; two BP-treated teeth were adjudicated using clinical information only. BP, iRoot BP Plus; CI, confidence interval.
Radiographic assessment within the 10–14-month window was available for 107/109 evaluable teeth, including 78/80 BP-treated teeth and 29/29 Ca(OH)2-treated teeth. Two BP-treated teeth were adjudicated using clinical follow-up information only. Among teeth evaluable at 12 months, the observed biological success proportion was 95.0% (76/80) in the BP group. Ca(OH)2-treated teeth had an observed biological success proportion of 100.0% among evaluable teeth (29/29), but this estimate was based on a smaller and less complete follow-up subset. These outcomes are presented descriptively only. Because treatment allocation was non-randomized and the groups differed in baseline symptom status, availability of hemostasis data, restorative strategy, and follow-up completeness, no causal inference regarding comparative medicament efficacy was made.
To avoid conflating restoration-related problems with pulpotomy failure, restoration-related complications were evaluated as a secondary outcome and were assessed only among teeth classified as biologically successful. As summarized in Table 2, restoration-related complications occurred in 3.9% (3/76) of biologically successful teeth in the BP group and in 6.9% (2/29) of biologically successful teeth in the Ca(OH)2 group. These findings were interpreted descriptively because the two material groups differed in baseline characteristics and follow-up completeness.
Coded-outcome consistency check and attrition-related sensitivity scenario
A coded-outcome consistency check was conducted using predefined 12-month coded outcomes recorded in the follow-up form. In the BP group, the 12-month clinical coded success rate was 91.2% (73/80), and the radiographic coded success rate was 94.9% (74/78). In the Ca(OH)2 group, the corresponding rates were 93.1% (27/29) for clinical-coded success and 100.0% (29/29) for radiographic-coded success. Because radiographic records were unavailable for some teeth at the 12-month follow-up, the denominator for radiographic coding was smaller than the number of teeth evaluable at 12 months. In the attrition-related sensitivity scenario assuming that all 12 non-evaluable Ca(OH)2-treated teeth represented biological failures, the Ca(OH)2 success proportion would be 29/41 (70.7%) instead of 29/29 (100.0%). Under the analogous conservative assumption that the single non-evaluable BP-treated tooth represented biological failure, the BP success proportion would be 76/81 (93.8%). These results underscore the vulnerability of the Ca(OH)2 descriptive estimate to attrition bias.
Exploratory BP-group outcome indicators observed with biological failure
To describe potential BP-group outcome indicators, we summarized preoperative and intraoperative variables among evaluable BP-treated teeth at 12 months (n=80), with key descriptive results shown in Table 3. Because only four biological failures occurred, these summaries were considered hypothesis-generating only and were not used for clinical risk stratification.
Table 3. Exploratory BP-group descriptive patterns by 12-month biological outcome.
| Factor (BP group) | Failure rate | Exact binomial 95% CI (%) |
|---|---|---|
| Preoperative symptoms | ||
| Symptomatic | 4/48 (8.3) | 2.3–20.0 |
| Asymptomatic | 0/32 (0) | 0.0–10.9 |
| Hemostasis time | ||
| ≥1 min | 3/20 (15.0) | 3.2–37.9 |
| <1 min | 1/60 (1.7) | 0.0–8.9 |
| Pulp exposure size (mm) | ||
| Successful cases | 1.0 [1.0–2.0] | – |
| Failed cases | 2.5 [1.75–3.0] | – |
| Cavity location | ||
| Proximal-occlusal | 4/45 (8.9) | 2.5–21.2 |
| Other | 0/35 (0) | 0.0–10.0 |
| Extent of coronal pulp removal | ||
| Complete | 4/56 (7.1) | 2.0–17.3 |
| Partial | 0/23 (0) | 0.0–14.8 |
| Final restoration | ||
| Non-SSC restoration | 4/68 (5.9) | 1.6–14.4 |
| SSC restoration | 0/12 (0) | 0.0–26.5 |
Data are presented as n/N (%) or median [interquartile range] unless otherwise specified. Exact binomial 95% CIs were calculated for absolute biological failure rates. Because only four biological failures occurred and several comparisons included zero-event cells, odds ratios, P values, and multivariable models were not reported. The findings should be interpreted as descriptive and hypothesis-generating rather than as stable inferential evidence. Denominators vary where variables were missing in the retrospective records. BP, iRoot BP Plus; CI, confidence interval; SSC, stainless steel crown.
All biological failures occurred in teeth that had documented preoperative symptoms (symptomatic: 4/48, 8.3%), whereas no failures were observed among asymptomatic/no-discomfort teeth (0/32, 0.0%). Because the symptomatic category was clinically heterogeneous and only four failures occurred, this finding should be interpreted as a descriptive pattern among a few failure cases rather than as evidence that BP pulpotomy is effective for irreversible pulpitis or for teeth with definitive signs of pulpal necrosis or infection.
Teeth requiring ≥1 min to achieve hemostasis had a biological failure rate of 15.0% (3/20; exact 95% CI: 3.2–37.9%), compared with 1.7% (1/60; exact 95% CI: 0.0–8.9%) among teeth in which hemostasis was achieved within <1 min. Because of the very small number of failures, this comparison was interpreted descriptively rather than as a stable effect estimate. Pulp exposure size was first examined as a continuous variable and was numerically larger in failed cases than in successful cases [median 2.5 (IQR, 1.75–3.0) vs. 1.0 (IQR, 1.0–2.0) mm], as illustrated in Figure 1. This pattern suggests that larger exposure measurements were more commonly observed among teeth that later met criteria for biological failure, but the finding requires validation in larger cohorts.
Figure 1.
Pulp exposure size by 12-month biological outcome in BP-treated teeth. BP, iRoot BP Plus.
In Figure 1, dots represent individual teeth; slight horizontal jitter was applied only to improve visualization of overlapping values. The horizontal line within each box represents the median, the box indicates the interquartile range, and whiskers indicate the non-outlier range. Pulp exposure size was analyzed as a continuous variable; the >1 mm threshold was used only in the exploratory cumulative indicator count.
To provide a hypothesis-generating summary of the observed BP-group failure pattern, we described a simple exploratory 0–3-point cumulative indicator count based on three chairside-available variables. Figure 2 presents descriptive 12-month biological failure rates across these strata. Failure rates were 0/19, 1/35, 0/16, and 3/10 for scores 0, 1, 2, and 3, respectively. Because the analysis was based on only four failures and sparse cells, including strata with zero failures, these findings should be interpreted descriptively and require external validation before any clinical use.
Figure 2.
12-month biological failure by exploratory cumulative indicator count in BP-treated teeth. BP, iRoot BP Plus.
In Figure 2, the cumulative indicator count included preoperative symptoms, hemostasis time ≥1 min, and pulp exposure size >1 mm. The findings are descriptive and hypothesis-generating because only four biological failures occurred. Four teeth in the BP group experienced biological failure; descriptive characteristics are summarized in Table 4. All failed teeth were symptomatic preoperatively, presented with proximal-occlusal cavity involvement, and were recorded as receiving non-SSC restorations. In three failed teeth, hemostasis required 1–3 min, and the recorded pulp exposure size was 2–3 mm. In the remaining case, despite hemostasis within <1 min and a pulp exposure size of 1 mm, infection-related signs developed during follow-up; radiography at 10 months showed a large radiolucent lesion involving the succedaneous tooth germ, and extraction was ultimately required. One child contributed two of the failed teeth.
Table 4. Summary of biological failure cases in the BP group at 12 months (n=4).
| Case | Age (years) | Tooth (FDI) | Hemostasis time (min) | Pulp exposure (mm) | Clinical record | Radiographic record | Management |
|---|---|---|---|---|---|---|---|
| 1 | 5.12 | 74 | 1–3 | 3 | Code12 =4: no carious cavity observed; restoration intact; percussion (+); mobility grade I; buccal gingival abscess; radiograph showed periapical radiolucency | CodeX12 =2: no root resorption; periapical radiolucency | Developed gingival parulis/abscess |
| 2 | 5.14 | 84 | 1–3 | 2 | 12-month clinical outcome code =4 | 12-month radiographic outcome code =2 | – |
| 3 | 6.52 | 65 | 1–3 | 3 | 12-month clinical outcome code =4 | 12-month radiographic outcome code =2 | – |
| 4 | 7.46 | 64 | <1 | 1 | At 10 months: gingival parulis; restoration intact; percussion (+); mobility grade II; buccal parulis noted | At 10 months: radiograph showed extensive periapical radiolucency involving the succedaneous tooth germ; extraction | Extraction; suspected involvement of the succedaneous tooth germ |
BP, iRoot BP Plus; FDI, Fédération Dentaire Internationale (World Dental Federation).
To further visualize outcome patterns across exploratory indicator profiles, Figure 3 presents preoperative and follow-up radiographs from two representative BP-group cases that were checked against the original clinical and radiographic records. In Figure 3, baseline and follow-up radiographs were matched by tooth site and verified against the original clinical records. Figure 3A,3B show a case with three exploratory indicators and biological success, whereas panels Figure 3C,3D show a case with three exploratory indicators and biological failure.
Figure 3.
Representative radiographic cases of primary molar pulpotomy with iRoot BP Plus. (A,B) Tooth 85 from a case with three exploratory indicators and biological success: documented symptoms, hemostasis time 1–3 min, and pulp exposure size 2.0 mm. (C,D) Tooth 74 from a case with three exploratory indicators and biological failure: documented symptoms, hemostasis time 1–3 min, and pulp exposure size 3.0 mm. Preoperative radiographic crops are shown in panels A and C; follow-up intraoral radiographs are shown in panels B and D.
Discussion
Main findings
This real-world follow-up study found that evaluable BP-treated primary molars had an observed 12-month biological success proportion of 95.0%. Ca(OH)2-treated teeth were described only as a non-comparable institutional context and were not used to infer comparative efficacy. Descriptive BP-group summaries showed that the four biological failures occurred in teeth with documented symptoms, longer hemostasis time, and larger pulp exposure size. However, because only four failures occurred, these findings should be interpreted as hypothesis-generating descriptive patterns rather than as evidence of a validated clinical decision tool.
Previous studies have generally reported favorable outcomes for BP in VPT of primary teeth. For example, a 3-year retrospective study comparing BP and MTA under general anesthesia observed consistently high clinical and radiographic success rates for BP at 24 and 36 months and, after propensity score matching, reported a higher success rate for BP than for MTA (22). Compared with studies conducted under more controlled operative conditions and standardized procedures, the observed 12-month biological success proportion in the present cohort was slightly lower. Still, this difference seems clinically plausible in a real-world outpatient environment, where greater case heterogeneity and more variable restorative strategies may magnify the influence of coronal seal integrity and reinfection risk on observed outcomes.
The present findings should not be interpreted as evidence supporting expansion of pulpotomy indications beyond current pediatric VPT guidelines (23). Although some recent retrospective studies have explored BP pulpotomy in clinically symptomatic primary molars, such evidence remains preliminary and should be interpreted cautiously. In the present study, the ‘symptomatic’ category was a broad chart-derived risk marker rather than a diagnosis of irreversible pulpitis. Therefore, the observed 12-month biological success proportion in BP-treated teeth should be interpreted within the limits of this retrospective classification and should not be used to justify pulpotomy in teeth with definitive signs of necrosis or infection, such as sinus tract or swelling of pulpal origin, when guideline-based management would indicate pulpectomy or extraction.
Hemostasis control and prognosis
Within the BP group, biological failure was more frequently observed among teeth requiring ≥1 min to achieve hemostasis than among those with hemostasis within <1 min. Hemostasis time is an immediately observable intraoperative variable and may reflect inflammatory burden or the difficulty of achieving adequate local control. However, the ≥1 min threshold used in this study was a pragmatic exploratory indicator rather than a data-driven, externally validated, or guideline-based cutoff (16). By contrast, the conventional 5-min threshold is commonly used as a clinical indication-related standard for determining whether pulpotomy remains appropriate. In this cohort, very few teeth had hemostasis times exceeding 5 min; therefore, a 5-min cutoff would have provided limited descriptive value. Given the small number of failures and the lack of multivariable or cluster-adjusted modeling, this descriptive pattern should be interpreted cautiously and requires validation in larger prospective cohorts.
Pulp exposure size and exploratory outcome indicators
In this study, pulp exposure size was examined primarily as a continuous variable and was numerically larger in failed cases than in successful cases. This observation may suggest that larger exposures reflect greater lesion extent, bacterial burden, or operative complexity. However, exposure-size measurement in primary molars may be imprecise, and the findings should be interpreted cautiously. The >1 mm threshold was used only as a pragmatic descriptive item in the exploratory cumulative indicator count and should not be interpreted as a validated clinical cutoff. Moreover, the exploratory indicator count was derived and evaluated in the same dataset, without split-sample validation, cross-validation, or external validation. Therefore, overfitting is likely, and the observed pattern should be regarded as proof of concept for future prospective validation rather than as a ready-to-use clinical score.
Coronal seal and restorative strategy
In the present study, all four failures occurred in teeth recorded as receiving non-SSC restorations, and failures were also observed in teeth with combined proximal-occlusal cavities (Table 4). However, because the number of failures was very small and no causal comparison of restorative strategies was possible, this finding should be interpreted only as a descriptive observation. It does not establish a protective effect of SSC restoration, nor does it allow comparison among different non-SSC restorative materials or designs. A randomized controlled trial compared a fast-setting bioceramic material with MTA and explicitly evaluated the impact of SSC placement, suggesting that the final restorative strategy is closely related to failure risk and highlighting the practical value of SSCs in reducing microleakage and improving longer-term stability (24). Thus, even when bioceramic materials perform well overall, real-world outpatient outcomes may be driven more strongly by the robustness of the coronal seal, especially in teeth with multi-surface caries and challenging proximal margin control.
In addition, a randomized controlled trial in symptomatic primary molar pulpotomy comparing MTA and bioceramic putty reported high 1-year success rates in both groups, with no statistically significant difference between materials. However, such evidence should be interpreted cautiously and does not override guideline-based indications for primary-tooth pulp therapy. In the present study, these reports were used only as background evidence suggesting that material choice alone may not fully explain short-term outcomes; they were not used to support generalized expansion of pulpotomy indications (18). It should also be emphasized that, as shown in Table 4, one failure case exhibited an extensive radiolucent lesion that may have involved the succedaneous tooth germ. Although biological failure was uncommon in this cohort, its potential clinical consequences warrant careful attention.
The representative cases in Figure 3 provide illustrative examples of different exploratory indicator profiles and follow-up appearances. These images should not be interpreted as validation of the cumulative indicator count. Notably, the case with three exploratory indicators and biological success illustrates that favorable short-term outcomes can occur even when several exploratory indicators are present; however, this single representative case should not be interpreted as evidence that SSC restoration causally prevents biological failure.
Public health and clinical implications
From a clinical perspective, this study supports further evaluation of BP as a pulpotomy medicament within guideline-based indications. Hemostasis time and pulp exposure size are routinely observable variables and may serve as candidate outcome-related indicators for future prospective studies. However, the present retrospective findings should not be used as validated criteria for treatment selection, follow-up scheduling, or restorative planning. Consistent attention to coronal seal quality remains important in primary molar pulpotomy, particularly in teeth with multi-surface cavities, but causal inference regarding restorative strategy cannot be made from the present data.
Limitations and future research
A key strength of this study is the explicit distinction between endpoints: biological success and restorative complications. This approach helps reduce misclassification bias that can occur when restoration-related problems are attributed to pulpotomy failure, and it also improves interpretability of observed biological outcomes. In addition, we described several routinely recorded preoperative and intraoperative variables as potential BP-group outcome indicators. Figure 1,2 were used only to visualize descriptive patterns in this cohort and should not be interpreted as evidence of a validated clinical decision tool.
Several limitations should be acknowledged. First, the retrospective design is inherently vulnerable to confounding, selection bias, and incomplete documentation. Treatment allocation was non-randomized, and the BP and Ca(OH)2 groups differed in baseline symptom status, availability of hemostasis data, restorative strategy, and follow-up completeness; therefore, no comparative efficacy conclusion can be drawn. Second, only four biological failures occurred in the BP group. This sparse event count precluded reliable multivariable modeling, cluster-adjusted regression, GEE, mixed-effects modeling, split-sample validation, or cross-validation. The exploratory cumulative indicator count should therefore be considered hypothesis-generating only. Third, because some children contributed more than one tooth, within-patient clustering may have affected variance estimates and inflated apparent precision. Fourth, the relatively low 12-month evaluable rate in the Ca(OH)2 group may have introduced substantial attrition bias. The reasons for missing 12-month evaluable follow-up could not be reliably determined for all non-evaluable teeth from the retrospective records. Fifth, the ‘symptomatic’ category was clinically heterogeneous. Symptoms such as chewing pain in pediatric patients may arise from food impaction in proximal carious lesions, local gingival inflammation, or periodontal ligament irritation rather than pulpal inflammation. Because the retrospective records did not consistently allow these causes to be separated, residual symptom misclassification may have affected subgroup interpretation. Sixth, measurement error in pulp exposure size is possible. In small primary molars, precise measurement of exposure diameter may be affected by bleeding, access limitation, and operator judgment. The retrospective records did not consistently document the measurement tool, operator calibration, or inter-/intra-operator reliability data; therefore, exposure-size findings should be interpreted cautiously. Seventh, several procedural variables were incompletely documented, including operator number, rubber dam isolation, detailed material-selection rationale, preoperative radiographic grading, intraoperative contamination control, postoperative medication use, and formal inter-examiner reliability statistics. These factors should be prioritized in future prospective multicenter studies.
Finally, the structured retrospective records captured final restoration mainly as SSC versus non-SSC restoration. Detailed information on non-SSC restorative materials, cavity coverage, margin location, marginal integrity at placement, and operator-assessed coronal seal quality was not consistently available. Therefore, the present data can only support a coarse descriptive comparison between SSC and non-SSC restoration categories, rather than a detailed analysis of specific definitive restorative techniques.
Conclusions
Based on a single-center, retrospective, real-world follow-up cohort, this study assessed 12-month outcomes of primary molar pulpotomy performed with BP, with Ca(OH)2-treated teeth described only as a non-comparable institutional context. Among evaluable BP-treated teeth, the observed 12-month biological success proportion was 95.0% in this retrospective cohort. Because the BP and Ca(OH)2 groups differed in baseline characteristics, documentation completeness, and follow-up completeness, the present study does not support conclusions regarding comparative efficacy between BP and Ca(OH)2. Within the BP group, the few biological failure events were descriptively observed in teeth with certain preoperative and intraoperative features, including documented symptoms, longer hemostasis time, and larger pulp exposure size. However, because only four biological failures occurred, these patterns should be considered exploratory and hypothesis-generating. The cumulative indicator count should not be interpreted as a validated risk score or as a basis for clinical decision-making without external validation in larger independent cohorts.
In addition, all failures occurred in teeth recorded as receiving non-SSC restorations and were observed mainly in proximal-occlusal cavities. This pattern is consistent with the general clinical importance of coronal seal quality, but it should be interpreted descriptively and does not establish a causal effect of SSC restoration or any specific non-SSC restorative technique. Future work should prospectively evaluate these candidate outcome-related indicators in larger multicenter cohorts and incorporate additional key variables, including sex, caries risk, isolation method, radiographic severity grading, measurement standardization, and restorative strategy, before any generalizable prediction model or clinical pathway is proposed.
Supplementary
The article’s supplementary files as
Acknowledgments
None.
Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study protocol was approved by the Ethics Committee of Nantong Stomatological Hospital (Approval No. PJ2026-010-01). Given the retrospective design, the ethics committee waived the requirement for individual informed consent.
Footnotes
Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://tp.amegroups.com/article/view/10.21037/tp-2026-0649/rc
Funding: This work was supported by the Nantong Science and Technology Plan Project (No. MSZ2024070), Nantong Natural Science Foundation Project (No. JCZ2025025), Nantong University Scientific Research Fund Clinical Medicine Special Funding Project (No. 2025JZ027), and Research Project on Teaching Reform at Nantong University (No. 2025J16). The funders had no role in study design, data collection, data analysis, interpretation, manuscript writing, or the decision to submit the manuscript.
Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://tp.amegroups.com/article/view/10.21037/tp-2026-0649/coif). The authors have no conflicts of interest to declare.
Data Sharing Statement
Available at https://tp.amegroups.com/article/view/10.21037/tp-2026-0649/dss
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