Patient-Specific Occlusal Splints Using MODJAW Kinematics

NCT07364552 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-01-23

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Istanbul University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-15
Primary Completion
2025-12-15
Completion
2025-12-25

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07364552 on ClinicalTrials.gov