Outcome of full pulpotomy versus partial radicular pulpotomy in mature permanent teeth with symptomatic irreversible pulpitis using Biodentine – A randomized controlled trial

Abstract

Background:

The constant demand for innovative and minimally invasive procedures aimed at preserving tooth structure challenges the effectiveness of conventional methods. One such approach is partial radicular pulpotomy, which necessitates further clinical trials to validate its efficacy over traditional full pulpectomies and root canal treatments.

Aim:

This study aims to evaluate and compare the outcome of full pulpotomy and partial radicular pulpotomy using Biodentine, in mature permanent molars with symptomatic irreversible pulpitis and spontaneous pain.

Methods:

Fifty patients with exposed carious pulp and symptomatic irreversible pulpitis were included, aged 15–35 years, randomly allocated to two groups: full pulpotomy (Group I) and partial radicular pulpotomy (Group II). Both the pulpotomies were performed following standardized protocols, with Biodentine.

Statistical analysis:

Success was assessed clinically and radiographically for up to 12 months using the intragroup Friedman test and the intergroup Mann–Whitney test.

Results:

Group I exhibited 78.3%, while for Group II, it was 86.4% success at 12 months, but the results were nonsignificant (P > 0.05).

Conclusion:

Partial radicular pulpotomy can be introduced as a successful new treatment option in cases of symptomatic irreversible pulpitis in mature permanent molars.

INTRODUCTION

The American Association of Endodontists (2020) defines symptomatic irreversible pulpitis (SIP) as a clinical diagnosis supported by objective and subjective evidence of the vital inflamed pulp accompanied by lingering thermal pain, spontaneous pain, or referred pain indicating that it is incapable of healing.[1] In most mature teeth diagnosed with irreversible pulpitis or apical periodontitis, root canal treatment is the therapy of choice to save the tooth.[2] Inherent in this procedure is the loss of dental hard tissue and subsequent weakening of the treated tooth, making them more prone to fracture.[3]

Histological studies have demonstrated that in teeth with irreversible pulpitis or carious pulp exposures, a necrotic area of varying size is present within the pulp chamber, often involving the coronal one-third of the radicular pulp. This necrotic tissue is typically colonized by bacteria, which contributes to the progression of the inflammatory response, complicating the treatment.[4,5] However, a few millimeters away from the bacterially colonized necrotic coronal tissue, it is not unusual to find a healthy pulpal architecture that is generally free from inflammation and bacteria.[6]

These findings suggest that in cases where a pulpotomy is performed, it may be possible to retain the radicular pulp, thereby avoiding the necessity for a more extensive pulpectomy. This paved the way for less invasive treatments like Endolight, which involves coronal pulpotomy and limited canal tissue removal, as proposed by Wolters et al. and confirmed by other researchers.[7,8] Baume et al. first introduced this understanding involving the removal of more inflamed tissue from canals (partial radicular pulpotomy) after full coronal pulpotomy and sealing with a bioactive material.[9] So far, clinical validation of this method is limited except one recent study by Shah et al. involving the association between time taken to achieve hemostasis and treatment outcome.[10]

Therefore, to shed more light on this area of vital pulp therapy (VPT), this study aims to evaluate and compare the clinical and radiographic success of the full pulpotomy and partial radicular pulpotomy using Biodentine, in mature permanent molars with SIP for a 12-month follow-up period.

METHODS

This randomized clinical study was conducted in the department of conservative dentistry and endodontics, with ethical clearance approved by the Ethical Committee of the Institute under registration number ECR/526/Inst/UP/2014/RR-20 and registered under Clinical Trials Registry number CTRI/2023/12/060901. After careful explanation of the treatment protocols involved, informed consent was taken before commencing the treatment.

Patients aged 15–35 years with mature permanent molars showing prolonged response to cold testing, often lasting several minutes, with or without tenderness to percussion, spontaneous dull pain, partially relieved by analgesics, clinical diagnosis confirming SIP, with or without periapical rarefaction, and no signs of necrosis, such as swelling or sinus tract, were included.

Patients with non-restorable teeth, no response to cold testing, sinus tract or swelling, uncontrolled bleeding 5 minutes after pulpotomy, insufficient bleeding upon pulp exposure suggesting necrotic or partially necrotic pulp, underlying medical conditions, or no pulp exposure following caries excavation were excluded.

Sample size calculation

After doing literature research on radicular pulpotomy, there was no literature available in 2023. Hence, we substituted the values of complete pulpotomy and partial pulpotomy of article[11] in G*Power Software 3.1.9.2 (Heinrich-Heine-Universitat, Dusseldorf, Germany). With effect size d = 1.22, alpha error probability = 0.05, actual power of study = 0.95, the sample size was calculated to be 19 per group. Due to the chances of dropout and patient compliance, the sample size was rounded off to 25 per group.

Study design

This was an in vivo, interventional, parallel-arm randomized clinical trial (chit system) study.

Selected patients were divided into two groups:

Group 1 (full coronal pulpotomy using Biodentine) [Figure 1]

Figure 1.

Group 1 – full pulpotomy. (a) preoperative intraoral periapical (IOPA), (b) postoperative IOPA, (c) 3-month follow-up IOPA, (d) 6-month follow-up IOPA, (e) 12-month follow-up IOPA

After clinical and radiographic examination, the tooth was anesthetized using 2% lignocaine hydrochloride with epinephrine 1:80,000 (Indoco Remedies Ltd., India) and then isolated with a rubber dam (GDC, India). The tooth surface was disinfected with 3% sodium hypochlorite (Parcan, Septodont, USA), and then, caries were removed with a sterile round bur (# 2 round diamond bur, API India) using a low-speed handpiece under sterile water spray. After complete carious excavation, pulp tissue was removed to the level of root canal orifices, and bleeding was controlled using a cotton pellet saturated with 3% sodium hypochlorite solution (Parcan, Septodont, USA) for 2 min, repeated for up to 5 min if required.

Group 2 (partial radicular pulpotomy using Biodentine) [Figure 2]

Figure 2.

Group 2 – partial radicular pulpotomy, (a) preoperative intraoral periapical (IOPA), (b) postoperative IOPA, (c) 3-month follow-up IOPA, (d) 6-month follow-up IOPA, (e) 12-month follow-up IOPA

After complete carious excavation and pulp tissue removal to the level of the canal orifice (as in Group 1), an additional 3–4 mm of radicular pulp was removed from the canals using a flat-ended tapered fissure bur (trimming and finishing taper pointed bur (7613)-12 blade, Prima Dental, India) with a high-speed handpiece under water coolant was done. The bleeding was controlled using cotton wrapped around a reamer saturated with 3% sodium hypochlorite solution (Parcan, Septodont, USA) in the canals.

In both the groups, following successful hemostasis, Biodentine (Septodont, Saint-Maur-des-Fossés, France) was mixed and gently placed over the pulp tissue at 3–4 mm thickness and allowed to set for 12 min. Followed by a layer of glass ionomer cement (GC Corporation, Tokyo, Japan) and composite restoration (Tetric N-Ceram, Ivoclar Vivadent).

RESULTS

Among 50 patients who received intervention, after removing dropout patients, 45 were analyzed for follow-up at 3, 6, and 12 months [Chart 1]. Success was assessed clinically and radiographically on the basis of intragroup Friedmann and intergroup Mann–Whitney test in SPSS software (version 21.0; IBM Corp., Armonk, NY, USA).

Chart 1.

The Preferred Reporting Items for Randomized Trials in Endodontics 2020 flowchart of participants

Clinical assessment involved pain assessment using pulp vitality tests (cold test and electric pulp test), palpation, percussion, examination for swelling and sinus tract, and coronal restoration integrity. Radiographic evaluations focused on periodontal ligament space widening, periapical radiolucency, root resorption, and dentin bridge formation.

No predilection of success rates with age or gender of the patient was observed.

Success rates [Table 1] for Group I were 78.3% and 86.4% for Group II at 12-month period, but the difference was statistically nonsignificant with both the groups.

Table 1.

Intragroup and intergroup evaluation of Success Rate, Dentine Bridge Formation, Root Canal Calcification at different follow-up

Groups	Follow-up (success rates)										Intragroup P (**)
	3 months			6 months				12 months
I (n=23)	20 (87%)			19 (82.6%)				18 (78.3%)			P=0.223
II (n=22)	20 (90.9%)			19 (86.4%)				19 (86.4%)			P=0.368
Intergroup P (#)	P=0.677			P=0.731				P=0.482
GROUPS	Follow-up (dentine bridge formation)											Intragroup P (**)
	3 months				6 months			12 months
	P	A			P	A		P	A
I (n=23)	1 (4.3%)	22 (95.7%)			3 (13%)	20 (87%)		5 (21.7%)	18 (78.3%)			P=0.050
II (n=22)	1 (4.5%)	21 (95.5%)			4 (18.2%)	18 (81.8%)		6 (27.3%)	16 (72.7%)			P=0.022
Intergroup P (#)	P=0.975				P=0.638			P=0.669
GROUPS	Follow-up (root canal calcification)										Intragroup P (**)
	3 months			6 months				12 months
	P		A	P			A	P		A
I (n=23)	0 (0%)		23 (100%)	2 (8.7%)			21 (91.3%)	5 (21.7%)		18 (78.3%)	P=0.22
II (n=22)	1 (4.5%)		21 (95.5%)	3 (13.6%)			19 (86.4%)	6 (27.3%)		16 (72.7%)	P=0.22
Intergroup P (#)	P=0.307			P=0.602				P=0.669

(#) Mann Whitney test; (**) Friedmann test* ≤0.05 statistically significant

There was no statistically significant difference in pain at all intervals in intergroup analysis. However, intragroup analysis revealed a gradual decrease in pain along with follow-up, which was statistically significant in both the groups.

Irrespective of the compared groups, an increase in the number of cases was observed, showing root canal calcification with time and dentinal bridge formation.

DISCUSSION

This randomized clinical study included all the eligible patients who agreed to participate in the study under the supervision of a specialist endodontist during the 12-month follow-up period.

In response to pulp inflammation, vascular and cellular reactions take place, which include vasodilatation, causing an increase in blood vessel permeability, leading to the accumulation of leukocytes and the migration of neutrophils from the blood vessels to the injury site. Complement components are triggered in the presence of antigen-antibody complexes. Histologically, under penetrating caries, exposed pulp exhibits microabscess formation.[12]

Recent studies challenge the traditional view that clinical symptoms poorly reflect pulp histology.[11,13] Evidence shows a strong correlation, with inflammation mainly in the coronal pulp during irreversible pulpitis, while the radicular pulp often remains healthy and can be preserved by selective removal of only the inflamed pulp tissue. Consequently, minimally invasive treatment approaches have gained prominence due to their high success rates and predictability in maintaining pulp vitality.[14,15,16,17]

Various studies have demonstrated that the success rate of full pulpotomy is around 74% over a 5-year follow-up.[18,19] These results draw emphasis on the need for newer, more viable VPT techniques that can offer better outcomes and minimize complications.

One such concept is the Endolight, by Wolters et al., which has also been supported by Philip and Suneja. According to their new classification, in cases of severe pulpitis, the treatment opted for is full pulpotomy. However, if one or more pulp stumps keep bleeding even after attempted hemostasis with a cotton pellet saturated with 2 mL 2% NaOCl, a superficial radicular pulpotomy can be carried out, whereby more inflamed tissue is removed from the canal up to 3–4 mm from the radiographic apex.[7,8] However, this notion is not new. In 1971, Baume et al. introduced radicular pulpotomy as a treatment option for vital pulps under specific conditions (category III pulps). His technique involved removing up to 3–5 mm of radicular pulp from the apex using cylindrical reamers, followed by immediate root canal filling. Histologically, this method promoted healing through osteopontin deposition, calcific sealing, and fibrosis without inflammation.[9]

In the present study, radicular pulpotomy was modified into a partial radicular pulpotomy. This modification was made due to challenges in achieving adequate hemorrhage control in some cases after a complete pulpotomy, as well as the more invasive nature of the full procedure.

In our study, Biodentine was selected as the pulp capping agent as it showed promising results which can likely be attributed to its advantages, including good sealing ability, adequate compressive strength, and quick setting time.[20] It also exhibits greater biocompatibility and lower cytotoxicity when compared with calcium hydroxide, mineral trioxide aggregate, or TheraCal PT.[13,21]

Pain is one of the primary reasons patients seek dental care. Almost every tooth in this study exhibited acute spontaneous or persistent pain when symptoms first appeared. By the conclusion of the 7^th day of our trial, only 4.5% of patients in Group II and 8.7% of patients in Group I felt pain [Table 2].

Table 2.

Intragroup and intergroup evaluation of Pain (in percentage) at different follow-ups

Groups	Follow-up										Intra-group P (**)
	1st Day		1st week		3 months		6 months		12 months
	P	A	P	A	P	A	P	A	P	A
I (n=23)	17 (73.9%)	6 (26.1%)	2 (8.7%)	21 (91.3%)	1 (4.3%)	20 (87%)	1 (4.3%)	19 (82.6%)	1 (4.3%)	18 (78.3%)	P≤0.000*
II (n=22)	15 (68.2%)	7 (31.8%)	1 (4.5%)	21 (95.5%)	1 (4.5%)	20 (90.9%)	1 (4.5%)	19 (86.4%)	0 (0%)	19 (86.4%)	P≤0.000*
Intergroup P (#)	P=0.675		P=0.581		P=0.662		P=0.718		P=0.516

(#) Mann Whitney test; (**) Friedmann test* ≤0.05 statistically significant

Dentinal bridge formation is a critical indicator of the effectiveness of pulp therapy. Histological examination of the pulp tissue revealed columnar cells with polarized nuclei extending into the invaginations of the bridge. These cells are indicative of odontoblast differentiation and tubular dentin formation.[22] In our study, Group II (27.3%) demonstrated high dentin bridge generation rates but was statistically nonsignificant [Table 1].

Root canal calcification is a common occurrence following vital pulp therapy (VPT), typically indicating ongoing odontoblastic activity and partial restoration of tooth vitality. This is not an indication of treatment failure.[23] The challenge arises when pulp canal obliteration happens [Table 1].

The primary cause of the potential inadequacies in the existing diagnostic methods’ ability to accurately diagnose pulpal necrosis and periapical involvement of chronic radicular pulpitis has been linked to delayed failures that may have been caused by bacterial infection. Bacterial leakage over time can cause the coronal restoration to fail, weakening the dentinal bridge and reducing its ability to protect the pulp underneath. Studies have shown that it takes 6 months to speculatively evaluate pulpotomy results.[24] To forecast the efficacy of endodontic therapy and determine the latency of biological issues, it was proposed that a 2-year follow-up period is necessary.[25]

Limitations of the study

The limitations of the study were less sample size, lack of histological examination leading to potential misdiagnoses and ineffective treatments, Biodentine radiopacity making it difficult to assess the thickness of the dentin bridge accurately, less follow-up period, and use of intraoral periapical radiographs, resulting in qualitative data.

CONCLUSION

• Partial radicular pulpotomy can be successfully employed as a treatment modality in teeth with SIP with or without symptomatic apical periodontitis

• Further research with a longer follow-up period and large sample size is needed to evaluate these results and define appropriate clinical guidelines of partial radicular pulpotomy.

Conflicts of interest

There are no conflicts of interest.

Funding Statement

Nil.