Abstract
Background
Conservative treatment of condylar fractures requires the use of occlusal splints. However, limited mouth opening, pain, and tooth damage often prevent timely impression taking, which hinders the fabrication of the occlusal splints. Therefore, there is an urgent need for a convenient and new method. The objective of this study is to evaluate the clinical outcomes and feasibility of innovative 3D-printed occlusal splints for the conservative treatment of condylar fractures.
Methods
This was a retrospective observational case series study aimed to investigate the clinical outcomes of 3D-printed occlusal splints in the conservative treatment of condylar fractures. The patients were divided into pediatric, adolescent, and adult groups according to age. The 3D-printed occlusal splint was secured to the maxilla for 2 months. Patients were instructed to perform mouth-opening exercises daily. Mouth opening was recorded before treatment and at the 3-month follow-up. Data were statistically analyzed.
Results
After 3 months of follow-up, no patients reported persistent pain, with mouth-opening and masticatory functions recovered. The postoperative mouth opening of all three groups was significantly greater compared with preoperative values, and the difference was statistically significant (P < 0.05). Regarding deviation of the mandible during mouth opening, the adolescent group showed significant improvement postoperatively (P < 0.05), whereas no statistically significant difference was observed in the pediatric group and the adult group.
Conclusion
The use of a 3D-printed occlusal splint combined with mouth-opening exercises is a feasible approach for the conservative treatment of condylar fractures.
Keywords: Mandibular, Condyle, Fracture, Conservative Treatment, Three-Dimensional Printing, Occlusal Splints
Background
The temporomandibular joint (TMJ) is an important anatomical and functional structure in the maxillofacial region. The condyle is a critical component of the TMJ, comprising its intracapsular portion and the condylar neck. It functions as a buffer during trauma and effectively absorbs external forces directed toward the skull. Within the TMJ complex, the condyle is relatively fragile and represents the most susceptible site of mandibular fractures [1, 2]. Occlusal disturbances, limited mouth opening, and pathological signs in the preauricular region (swelling, tenderness, crepitus) are important indicators for the diagnosis of condylar fractures [3]. The Association for the Study of Internal Fixation classification system categorizes condylar fractures into those of the condylar head, condylar neck, or condylar base [4].
Generally, conservative treatment is the first choice for condylar fractures in children and adolescents, with the primary therapeutic goal of restoring TMJ function and occlusal relationships [5, 6]. The advantage of conservative treatment lies in enabling early functional exercises in pediatric patients. With adequate functional stimulation, the condyle can undergo sufficient remodeling during fracture healing and subsequent growth [7, 8]. In the treatment of adult condylar fractures, Ellis et al. found no significant difference in bite force following conservative treatment compared with open treatment [9–11]. Conservative treatment can promote condylar fracture healing and TMJ functional recovery through occlusal adjustment and functional exercises, avoiding surgical trauma and postoperative complications.
Conservative treatment of condylar fractures requires the use of occlusal splints [12, 13]. However, limited mouth opening, pain, and tooth damage often prevent timely impression taking, which hinders the fabrication of the occlusal splints. In addition, for patients with fractures in other parts, intraoperative impression taking is prone to causing contamination. Therefore, there is an urgent need for a convenient new method. To address these problems, Trupthi [14] introduced thermoplastic transparent splints, while Grippaudo et al. [15] further improved such splints with advanced materials and design to enhance patient comfort. Despite these improvements, conventional splints still have limitations.
As a novel approach, the personalized three-dimensional (3D) printed occlusal splints, were developed to address these issues. This study aims to evaluate the clinical outcomes and feasibility of 3D-printed occlusal splints in the conservative treatment of condylar fractures.
Accordingly, the null hypothesis (H0) was that there would be no significant differences in maximum interincisal distance and mouth opening deviation in patients with condylar fractures before and after conservative treatment using 3D-printed occlusal splints. The alternative hypothesis (H1) was that such intervention could be associated with improved mouth opening function and TMJ function.
Methods
This was a retrospective, self-controlled observational study with pre- and post-treatment comparisons. The subjects were patients with condylar fractures treated at the Department of Oral and Maxillofacial Trauma and Temporomandibular Joint Surgery, School and Hospital of Stomatology, Wuhan University, from October 2022 to October 2025. The study was conducted in accordance with the Declaration of Helsinki, and the protocol was approved by the Medical Ethics Committee of School and Hospital of Stomatology, Wuhan University (Ethical approval numbers: WDKQ2025C01, WDKQ2024C23). Written informed consent was obtained from all patients or their legal guardians. During the study period, all patients with condylar fractures were evaluated. Patients with lateral dislocation of the condyle or dislocation of the condyle into the middle cranial fossa were recommended for surgical treatment and were excluded from this study. All patients included in this study received conservative treatment due to mild fracture severity or refusal of surgery by the patients or their families, and signed informed consent for conservative treatment.
Inclusion and exclusion criteria
This study included patients who met the following criteria: patients treated with 3D-printed occlusal splint for condylar fractures; patients with imaging evidence confirming condylar fractures; patients with a follow-up period of at least 3 months; and patients who provided signed informed consent.
This study excluded patients who met the following criteria: patients with lateral dislocation of the condyle; patients with dislocation of the condyle into the middle cranial fossa.
The patients were categorized by age into the child group (≤ 12 years), adolescent group (13–18 years), and adult group (> 18 years). According to fracture type, they were divided into condylar head fractures, condylar neck fractures, and subcondylar fractures.
Potential study candidates were identified through the following information sources: surgical records, medical records, and imaging examinations from the Oral and Maxillofacial Trauma and Temporomandibular Joint Surgery Department of Wuhan University School of Stomatology.
Digital workflow and surgical operation
The treatment protocol for patients with condylar fractures using innovative 3D-printed occlusal splint was as follows: Spiral computed tomography (CT) was used as the imaging examination for all patients. Spiral CT was conducted to acquire data, followed by 3D reconstruction of the post-fracture maxillomandibular morphology using Mimics software to simulate the presurgical occlusal status. The spiral CT data were imported into Mimics software to reconstruct three-dimensional models of the mandible, maxilla, and dentition. The bilateral occlusal relationships were adjusted to symmetry, and a normal mandibular occlusal plane was established to ensure no occlusal interference. The displaced dentition segments were repositioned to restore a normal occlusal plane. An occlusal splint model was designed to ensure precise fitting with the repositioned dentition, providing stable support for fracture reduction. The files were then exported and 3D-printed using a stereolithography apparatus (JOYE300/JOYE600, JOYE Hi-Tech (Hubei) Co., Ltd.) with printing material 8111X. The 3D-printed occlusal splint was engineered to achieve simultaneous global occlusal elevation and inferior mandibular repositioning, thereby widening the TMJ space and facilitating functional recovery (Fig. 1). The 3D-printed occlusal splint was fabricated from photopolymer resin(a copolymer of epoxy resin and acrylate), with a thickness of 1.5 mm. Consistent with conventional computer aided design/computer aided manufacture (CAD/CAM) splints for orthognathic surgery, this splint aims to reconstruct stable occlusion and adopts the same design procedure. It removes the intraoral scanning step to fit patients with mouth opening limitation after fractures. Equipped with reserved marginal holes, the splint can be fixed on the maxilla for two months of long-term use, differing from orthognathic splints that are only used intraoperatively. Both belong to anatomical splints for occlusal stabilization. During the surgical procedure, intermaxillary fixation (IMF) screws were first inserted into the mucosa of the maxillary vestibular sulcus. Wires were then passed through the circular holes to secure the 3D-printed occlusal splint to the IMF screws, thereby achieving global occlusal elevation [16–18]. During the operation, the occlusal relationship was evaluated. If the occlusal relationship was satisfactory, IMF screws did not need to be implanted into the mandibular alveolar bone. In cases of poor occlusal relationship, IMF screws were implanted into the mandibular alveolar bone for the purpose of postoperative traction. The 3D printed occlusal splint could be used to check intraoperatively whether the pre-traumatic occlusal relationship can be restored when combined with fractures of other parts of the mandible. For patients with concomitant fractures in other parts of the mandible, open reduction and internal fixation of mandibular fractures are performed simultaneously with conservative treatment of condylar fractures.
Fig. 1.
A Left condylar fracture with anterior-medial displacement of the condylar head. B The 3D-printed occlusal splint was used to guide the overall downward movement of the mandible, increasing the joint space of the TMJ, relieving the entrapment of the articular disc, and promoting the recovery of the TMJ function. Red arrow: 3D-printed occlusal splint, which overall increased the occlusion by 1.5 mm. Yellow dotted line: TMJ space
The 3D-printed occlusal splint was secured to the maxilla for a 2-month period. During this period, the patient was required to perform mouth-opening exercises. For patients with mouth opening deviation, this study adopted guided elastic traction instead of complete intermaxillary fixation. Traction was applied using elastics suspended from IMF screws implanted in the maxilla and mandible, which were removed during meals and mouth-opening exercises. The duration of traction was adjusted according to the recovery of mouth-opening deviation and occlusal relationship. The patient was instructed to maintain a liquid diet for 3 months. A liquid diet was prescribed to avoid irritation to the fracture site caused by mastication and promote fracture healing. After 3 months, the diet was gradually transitioned to a semi-liquid diet and then to a regular diet, based on the recovery of mouth-opening function and fracture healing status.
Outcome measures
All measurements were performed independently by two calibrated dentists who had completed a standardized training session to ensure consistent measurement criteria. The final value was recorded as the mean of the two measurements; if the difference between measurements exceeded 1 mm, a re-measurement was conducted. Maximum mouth opening was measured as the vertical distance between the incisal edges of the maxillary and mandibular central incisors with the patient seated upright and the head in a neutral position, recorded to the nearest 1 mm. During maximum mouth opening, the horizontal deviation of the mandibular central incisor relative to the maxillary central incisor was measured to the nearest 1 mm using a straight ruler (precision 1 mm), with consistent body position and fixed measurement points. Postoperative pain was assessed qualitatively based on patients’ subjective complaints and clinical records. No validated quantitative pain scale was used.
Study variables
Data analysis was conducted with SPSS 20.0 (IBM). Shapiro–Wilk tests were used to assess normality. Preoperative data were normally distributed, while postoperative data were not; therefore, parametric tests were not appropriate. Normally distributed data are reported as mean ± standard deviation (
± s), and non-normally distributed data as median (interquartile range), M (P25, P75). Given the self-controlled pre- and post-treatment design and non-normal data distribution, comparisons between preoperative and postoperative measurements were performed using the Wilcoxon signed-rank test. A two-sided significance level was set at α = 0.05, with P < 0.05 considered statistically significant.
As the paired differences did not follow a normal distribution, sample size estimation and post-hoc power analysis were performed using G*Power 3.1 software, approximated by paired t-test. A two-sided type I error rate (α) of 0.05 and a target power (1 − β) of 0.80 were set. Subgroup analyses were conducted in an exploratory manner due to relatively small subgroup sizes, and no adjustment for multiple comparisons was performed. Using the smaller effect size of mouth opening deviation (dz = 0.38) as the conservative estimate, the required sample size was calculated to be 57 cases. A total of 69 patients were included in this study, and the post-hoc power for mouth opening deviation was 87.5%, indicating sufficient statistical power.
Results
General information
A total of 69 patients were enrolled in this study, including 51 males (73.91%) and 18 females (26.09%). Age ranged from 2 to 69 years, with a mean age of 18.65 ± 17.71 years. Patients were divided into three groups by age: 35 children (≤ 12 years, 50.72%), 15 adolescents (13–18 years, 21.74%), and 19 adults (> 18 years, 27.54%). Causes of injury included falls in 47 patients (68.12%), high‑altitude falls in 4 patients (5.80%), and traffic accidents in 18 patients (26.09%). By fracture site, there were 56 condylar head fractures (81.16%), 3 condylar neck fractures (4.35%), and 10 subcondylar fractures (14.49%). All patients presented with preoperative limited mouth opening, and 10 patients exhibited mouth opening deviation. Thirty‑nine patients had unilateral condylar fractures (56.52%), and 30 had bilateral condylar fractures (43.48%).
Mouth opening analysis
Preoperative mouth opening in the child group was 15.00 (10.00, 20.00) mm, and postoperative mouth opening was 37.00 (35.00, 37.00) mm. Postoperative mouth opening was significantly greater than the preoperative value (Wilcoxon signed-rank test, Z = − 5.164, P < 0.001). In the adolescent group, preoperative mouth opening was 17.00 (15.00, 24.00) mm, and postoperative mouth opening was 37.00 (36.00, 37.00) mm. Postoperative mouth opening was significantly greater than the preoperative value (Wilcoxon signed-rank test, Z = − 3.413, P = 0.001). In the adult group, preoperative mouth opening was 17.00 (15.00, 20.00) mm, and postoperative mouth opening was 37.00 (35.00, 37.00) mm. Postoperative mouth opening was significantly greater than the preoperative value (Wilcoxon signed-rank test, Z = − 3.830, P < 0.001).
Mouth opening deviation analysis
In the child group, preoperative deviation was 0 (0, 3.00) mm, and postoperative deviation was 0 (0, 1.00) mm. No statistically significant difference was observed (Wilcoxon signed-rank test, Z = −1.633, P = 0.102). In the adolescent group, preoperative deviation was 0 (0, 3.00) mm, and postoperative deviation was 0 (0, 0) mm. A statistically significant difference was observed (Wilcoxon signed-rank test, Z = − 2.070, P = 0.038). In the adult group, preoperative deviation was 0 (0, 3.00) mm, and postoperative deviation was 0 (0, 2.00) mm. No statistically significant difference was observed (Wilcoxon signed-rank test, Z = − 0.535, P = 0.593).
Complications
No severe complications (such as ankylosis, nonunion, or infection) occurred in the 69 patients included in this study.
Summary of results
Based on the prespecified hypotheses, mouth opening was significantly greater after intervention in all three groups, leading to rejection of H0 in favor of H1 for this outcome. For mouth opening deviation, a statistically significant difference was observed only in the adolescent group, supporting rejection of H0 in favor of H1 for this outcome. No statistically significant difference was observed in the child and adult groups, and H0 could not be rejected accordingly.
These findings reflect within-group comparisons from a retrospective self-controlled design without a comparative group and should be interpreted as preliminary observational results.
Representative cases are shown in Figs. 2 and 3.
Fig. 2.
A and E Following open reduction and internal fixation of the mandibular symphysis fracture, a 3D-printed occlusal splint was secured to the maxilla for the conservative treatment of condylar fracture. The 3D-printed occlusal splint was used to guide the overall downward movement of the mandible, increasing the joint space of the TMJ. Right condylar head displacement in an anterior-inferomedial direction, with reduced height of the mandibular ramus. B and F At the 3-month follow-up, spiral CT basal cranial and lateral views demonstrate healing of the condylar fracture. The condylar head is positioned below the articular tubercle, and bone resorption with remodeling is observed in the lateral cortical bone of the residual mandibular ramus stump. C and G At the 6-month follow-up, spiral CT basal cranial and lateral views demonstrate that the condyle further remodels with a tendency to return to the articular fossa. The articular tubercle becomes slightly flattened. D and H At the 1-month follow-up, the patient's interincisal distance was basically normal, with the splint fixed to the maxillary dentition. At the end of mouth opening, the mandible deviated 3 mm to the right. At the 6-month follow-up, the patient's interincisal distance further increased, and the deviation during maximum mouth opening was corrected
Fig. 3.
A and D Preoperative spiral CT demonstrated the fracture of the left condyle. The left condyle was displaced anteromedially, and the height of the mandibular ramus was reduced. B and E At the 3-month follow-up, the condylar fracture has achieved bony union and undergone bony remodeling, while the condylar head shows a trend of returning to the articular fossa. C and F At the 3-month follow-up, the patient's facial shape is basically symmetrical. The patient demonstrated remarkable improvement in both the interincisal distance and mouth opening deviation. A slight 1-mm deviation of the midline to the left was observed during maximal interincisal distance
Discussion
The primary findings of this study demonstrated a statistically significant increase in mouth opening in all condylar fracture patients, with age-specific changes in mouth opening deviation restricted to adolescents. A cross-age group comparison of oral function before and after treatment revealed that postoperative mouth opening was significantly greater in all three groups (P < 0.05), which further supports that this conservative treatment was associated with increased mouth opening in pediatric, adolescent and adult patients with condylar fractures. In terms of mouth opening deviation, a statistically significant change was observed only in the adolescent group (P < 0.05), with no statistically significant change seen in the child and adult groups. This observation may be associated with the limited sample size, mild baseline deviation resulting in a floor effect, and varying jaw growth and remodeling capacities across different age groups—factors that include reduced statistical power to detect subtle changes, little clinical room for change in preoperatively mild deviation, and a more pronounced treatment response driven by stronger adaptive jaw and occlusal remodeling during adolescence (Tables 1 and 2).
Table 1.
Changes in mouth opening before and after treatment
| Group | Preoperative (mm) | Postoperative (mm) | Z value | P value |
|---|---|---|---|---|
| Children(n = 35) | 15.00 (10.00, 20.00) | 37.00(35.00, 37.00) | − 5.164 | < 0.001 |
| Adolescents(n = 15) | 17.00 (15.00, 24.00) | 37.00(36.00, 37.00) | − 3.413 | 0.001 |
| Adults (n = 19) | 17.00 (15.00, 20.00) | 37.00(35.00, 37.00) | − 3.830 | < 0.001 |
Table 2.
Changes in mouth opening deviation before and after treatment
| Group | Preoperative (mm) | Postoperative (mm) | Z value | P value |
|---|---|---|---|---|
| Children (n = 35) | 0 (0, 3.00) | 0 (0, 1.00) | − 1.633 | 0.102 |
| Adolescents(n = 15) | 0 (0, 3.00) | 0 (0, 0) | − 2.070 | 0.038 |
| Adults (n = 19) | 0 (0, 3.00) | 0 (0, 2.00) | − 0.535 | 0.593 |
Safety of 3D-printed occlusal splints
3D-printed occlusal splints avoid the potential risks caused by intraoral impression taking. Patients with condylar fractures often have limited mouth opening and pain, which impede intraoral impression taking. For pediatric patients, general anesthesia is usually required for impression taking. In addition, loose teeth or tooth fractures caused by trauma increase the difficulty of impression taking. Moreover, during the impression taking process, loose teeth, tooth fragments or impression compound may fall off into the oral cavity or even the airway, posing safety hazards [16].
Design of 3D-printed occlusal splints
Traditional occlusal splints, which only elevate the posterior teeth, resulted in contact between the upper and lower dental arches occurring solely in the posterior elevated area. This concentrates the occlusal force on just two limited contact points; the excessive pressure could cause occlusal trauma to the teeth. Such localized point contact also impaired the patient’s ability to eat. In contrast, 3D-printed occlusal splints evenly elevate the entire dental arch, which facilitates the dispersion of occlusal force and enhances the stability of the mandibular dental arch [19, 20]. Therefore, it is also more conducive to the recovery of patients' masticatory function. According to our observations, the optimal value for the overall uniform elevation of the dental arch was 1.5 mm. Excessively thick occlusal splints would hinder occlusal recovery during and after treatment, whereas overly thin splints would fail to achieve the desired therapeutic effect. A 1.5 mm thickness, however, is ideal-it did not cause an open bite during or after surgery. As the primary functional zone of the articular disc, the intermediate zone has a thickness of approximately 1 mm [21–23]. and the increased 1.5 mm joint space can just accommodate the articular disc, thereby promoting the self-recovery of the anteriorly displaced articular disc [24–26]. Additionally, for condylar fractures complicated with mandibular body fractures, 3D-printed occlusal splints can assist in mandibular retraction [13].
Clinical outcomes of 3D-printed occlusal splints
All patients regained normal mouth opening and masticatory function, which indicated the restoration of TMJ function. Notably, even patients with anterior-inferomedial displacement of the condylar head achieved favorable TMJ function recovery. Radiological assessments at the 3-month follow-up showed that these condylar heads had undergone bony union and exhibited a tendency to migrate and remodel toward the glenoid fossa; their positions [27] however, remained in the anterior-inferomedial direction.
The condylar head acts as the functional center for joint movement [28]. Based on previous literature, such findings may imply a potential anterior and inferior shift of the TMJ functional center. The inferior shift of the joint's functional center compensated for the reduced height of the mandibular ramus, which may explain why patients with unilateral condylar fractures complicated by anterior-inferomedial displacement achieved restoration of postoperative occlusal alignment and resolution of mouth opening deviation [7, 8, 26].
Limitations
This study was a non-controlled retrospective self-controlled study without a comparison group. Therefore, causal attribution cannot be confirmed, and we cannot disentangle the contributions of the splint, functional exercises, and natural healing. Conclusions should be interpreted cautiously. The study population exhibited high heterogeneity, including a wide age range, different fracture types, and both unilateral and bilateral condylar fractures, which was not adjusted for in the analysis and may limit the generalizability of subgroup findings. Prospective controlled studies are warranted in the future to further evaluate the clinical outcomes and comparative effectiveness of 3D-printed occlusal splints. TMJ remodeling requires a long period of time; therefore, the follow-up period will be extended in the later stage to observe long-term outcomes. In addition, quantitative indicators such as VAS scores will be included in subsequent studies to more accurately assess pain.
Conclusion
The use of a 3D-printed occlusal splint combined with mouth-opening exercises is a feasible approach for the conservative treatment of condylar fractures.
Acknowledgements
We thank Prof. Li Zubing and Prof. Li Zhi for clinical suggestions.
Abbreviations
- CT
Computed tomography
- 3D
Three-dimensional
- TMJ
Temporomandibular joint
- CAD/CAM
Computer aided design/computer aided manufacture
- IMF
Intermaxillary fixation
Authors’ contributions
ZDF designed the study protocol, collected and analyzed the clinical data, and drafted the initial version of the manuscript. LK supervised the study design, revised the manuscript critically for intellectual content, and served as the corresponding author responsible for final manuscript submission and communication with the journal. All authors read and approved the final manuscript.
Funding
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
Data availability
All data generated or analysed during this study are included in this published article. Written informed consent for publication of their clinical details and clinical images was obtained from the patient. A copy of the consent form is available for review by the Editor of this journal.
Declarations
Ethics approval and consent to participate
We have read the Helsinki Declaration and have followed the guidelines in this investigation. A specific informed consent form was designed, and the study was approved by the Medical Ethics Committee of Wuhan University School of Stomatology(No. WDKQ2024C23; No. WDKQ2025C01). All participants in this study provided written informed consent prior to their involvement.
Consent for publication
All presentations of case reports have consent for publication.
Competing interests
The authors declare no competing interests.
Footnotes
Publisher’s Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
All data generated or analysed during this study are included in this published article. Written informed consent for publication of their clinical details and clinical images was obtained from the patient. A copy of the consent form is available for review by the Editor of this journal.



