Patient-Specific Occlusal Splints Using MODJAW Kinematics

NCT07364552 | Completed

• 1 other identifier: U-116S697
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bruxism

Keywords

Occlusal splint

Outcome Measures

Primary Outcomes (1)

• Improvement in mandibular movement patterns

  Mandibular movements will be recorded using MODJAW 3D jaw-tracking system. Parameters include opening, lateral, and protrusive excursions, as well as path stability and range of motion. The primary analysis will compare baseline mandibular kinematics to post-intervention measurements between the MODJAW-based splint group and the standard splint group.

  Baseline and after 8 weeks of splint use

Secondary Outcomes (2)

• TMJ pain levels

  Baseline and after 8 weeks of splint use

• Comfort and satisfaction

  Baseline and after 8 weeks of splint use

Study Arms (2)

MODJAW-Based Patient-Specific Splint

EXPERIMENTAL

Participants receive a patient-specific occlusal splint designed using MODJAW 3D mandibular kinematic data. The splint is fabricated via CAD/CAM and worn according to study instructions for 8 weeks.

Device: MODJAW-Based Patient-Specific Occlusal Splint

Standard Occlusal Splint

EXPERIMENTAL

Participants receive a conventional occlusal splint fabricated using standard methods. The splint is worn according to study instructions for 8 weeks.

Device: Standard Occlusal Splint

Interventions

MODJAW-Based Patient-Specific Occlusal Splint DEVICE

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.

MODJAW-Based Patient-Specific Splint

Standard Occlusal Splint DEVICE

A conventional occlusal splint made using standard methods without patient-specific mandibular movement data. Worn nightly (or per instructions) for 8 weeks.

Standard Occlusal Splint

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-50 years
• Diagnosed with mild-to-moderate bruxism or temporomandibular joint (TMJ) dysfunction
• Willingness and ability to comply with splint use and study visits
• Signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul university

Istanbul, 34844, Turkey (Türkiye)

Location

Related Links

• Participants will wear their assigned splints for 8 weeks, following study instructions. Outcomes will be assessed at baseline and at the end of the 8-week period. Primary outcomes include improvement in mandibular movement patterns measured using MODJAW

MeSH Terms

Conditions

Bruxism

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Habits; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not applicable; this is an open-label study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: Participants are randomly assigned to one of two groups: (1) MODJAW-based patient-specific splint group, or (2) standard occlusal splint group. Each participant follows their assigned intervention for 8 weeks. Outcomes are compared between the groups at baseline and post-intervention.

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 23, 2026
• Study Start: October 15, 2025
• Primary Completion: December 15, 2025
• Study Completion: December 25, 2025
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

TU (1)