NCT07364552

Patient-Specific Occlusal Splints Using MODJAW Kinematics

Patient-Specific Occlusal Splints Designed Using MODJAW Kinematic Data: A Prospective Clinical Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Istanbul University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This clinical study is designed to evaluate the effectiveness of patient-specific occlusal splints created using MODJAW, a jaw-tracking device that records 3D mandibular movements. Occlusal splints are commonly used to treat bruxism (teeth grinding) and temporomandibular joint (TMJ) disorders, which can cause jaw pain, headaches, and worn teeth. Traditional splints are made using standard designs that do not consider each patient's unique jaw movements. In this study, 40 participants with mild-to-moderate bruxism or TMJ dysfunction will be randomly assigned to two groups. One group will receive custom splints designed using MODJAW kinematic data, while the other group will receive standard occlusal splints. Participants will use their assigned splint for 8 weeks. The study will measure: Jaw movement patterns using MODJAW TMJ pain levels Patient comfort and satisfaction The main goal is to determine whether MODJAW-based, patient-specific splints provide better jaw function, reduced pain, decreased teeth grinding, and higher patient satisfaction compared to standard splints. Participants will be monitored throughout the study to ensure safety, comfort, and proper splint use. This study is expected to help dentists design more effective, personalized splints in the future and improve treatment outcomes for people with jaw disorders or bruxism.

Detailed description

Detailed Description: Background and Rationale: Bruxism and temporomandibular joint (TMJ) disorders are common conditions that can lead to jaw pain, headaches, tooth wear, and impaired quality of life. Occlusal splints are commonly prescribed to manage these conditions by stabilizing the jaw and distributing occlusal forces. Standard splints, however, are typically fabricated using uniform designs that do not account for the individual jaw movement patterns of each patient. Recent advances in digital dentistry, including the use of jaw-tracking devices such as MODJAW, allow clinicians to capture three-dimensional mandibular kinematics in real time. By using this information, occlusal splints can be designed to match the specific movement patterns of each patient, potentially improving comfort, jaw function, and clinical outcomes. This study aims to evaluate whether patient-specific occlusal splints designed using MODJAW kinematic data provide superior clinical outcomes compared to standard occlusal splints. Study Objectives: To compare mandibular movement patterns between MODJAW-based patient-specific splints and standard occlusal splints. To evaluate the effect of MODJAW-based splints on bruxism frequency and intensity. To assess TMJ pain reduction in participants using MODJAW-based splints versus standard splints. To determine patient satisfaction and comfort with patient-specific versus standard splints. Study Design: This is a prospective, randomized, controlled interventional study. Forty participants with mild-to-moderate bruxism or TMJ dysfunction will be randomly assigned to one of two groups: MODJAW group (n=20): Participants will receive a patient-specific occlusal splint designed based on 3D mandibular kinematic data collected with MODJAW. Standard splint group (n=20): Participants will receive a conventional occlusal splint fabricated using standard methods. The study duration for each participant is 8 weeks, during which participants will wear their assigned splints according to instructions and attend follow-up assessments. Inclusion Criteria: Age 18-50 years Diagnosed with mild-to-moderate bruxism or TMJ dysfunction Willingness and ability to comply with splint use and study visits Signed informed consent Exclusion Criteria: Severe dental loss or existing prosthetic devices interfering with splint placement Systemic medical conditions affecting jaw function History of TMJ trauma or surgery Pregnancy or breastfeeding Allergy to splint materials Study Procedures: Screening and Baseline Assessment: Clinical examination of dentition and TMJ Recording baseline jaw movements using MODJAW (for both groups) Baseline assessment of bruxism frequency, TMJ pain (VAS score), and patient-reported comfort Splint Fabrication: MODJAW group: CAD/CAM splints designed using mandibular movement data captured by MODJAW Standard group: Conventional splints fabricated according to standard occlusal design Splint Use: Participants instructed to wear splints nightly (or as directed) for 8 weeks Weekly check-ins to monitor compliance and comfort Follow-Up Assessments (Week 4 and Week 8): Repeat MODJAW recordings to evaluate changes in mandibular movement Assess TMJ pain, bruxism frequency and intensity Collect patient satisfaction and comfort scores via 5-point Likert scale Record any adverse events Outcome Measures: Primary Outcome: Changes in mandibular movement patterns as measured by MODJAW Secondary Outcomes: Reduction in TMJ pain (VAS score) Patient-reported satisfaction and comfort Data Analysis: Within-group comparisons: Paired t-tests or Wilcoxon signed-rank tests Between-group comparisons: Mann-Whitney U test Categorical outcomes: Chi-square or Fisher's exact test Statistical significance set at p \< 0.05 Safety Considerations: Participants monitored for adverse events related to splint use, including discomfort, tissue irritation, or allergic reactions Participants may withdraw at any time All data handled according to confidentiality and privacy guidelines Significance: This study will provide evidence on the effectiveness of patient-specific, MODJAW-guided occlusal splints in improving jaw function, reducing bruxism, and increasing patient satisfaction. The results may support the adoption of kinematic data in routine occlusal splint design and contribute to personalized dentistry approaches.

Conditions

• Bruxism

Interventions

Type	Name	Description
DEVICE	MODJAW-Based Patient-Specific Occlusal Splint	A custom occlusal splint designed using MODJAW-recorded 3D mandibular movement data. Fabricated via CAD/CAM to fit the patient's unique jaw movements. Worn nightly (or per instructions) for 8 weeks.
DEVICE	Standard Occlusal Splint	A conventional occlusal splint made using standard methods without patient-specific mandibular movement data. Worn nightly (or per instructions) for 8 weeks.

Timeline

• Start date: 2025-10-15
• Primary completion: 2025-12-15
• Completion: 2025-12-25
• First posted: 2026-01-23
• Last updated: 2026-01-23

Locations

1 site across 1 country: Turkey (Türkiye)