Completed

MOD-SPPersonalized Occlusal Splints Using MODJAW Kinematic Data for Bruxism and TMJ Disorders

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What is being tested

MODJAW-Based Patient-Specific Occlusal Splint

+ Standard Occlusal Splint

Device
Who is being recruted

Behavior+2

+ Bruxism

+ Habits

From 18 to 50 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: October 2025
See protocol details

Summary

Principal SponsorIstanbul University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 15, 2025

Actual date on which the first participant was enrolled.

This study focuses on bruxism and temporomandibular joint (TMJ) disorders, conditions that can cause jaw pain, headaches, tooth wear, and reduced quality of life. Occlusal splints, devices that stabilize the jaw and distribute biting forces, are commonly used to manage these conditions. However, standard splints do not account for individual jaw movement patterns. This study aims to evaluate if patient-specific occlusal splints, designed using MODJAW kinematic data for individual jaw movements, provide better clinical outcomes compared to standard splints. The study could potentially improve comfort, jaw function, and clinical outcomes for those suffering from bruxism or TMJ disorders. The study is a prospective, randomized, controlled interventional study involving 40 participants with mild-to-moderate bruxism or TMJ dysfunction. Participants will be divided into two groups. The MODJAW group will receive a patient-specific occlusal splint designed using 3D mandibular kinematic data collected with MODJAW. The standard splint group will receive a conventional occlusal splint. Over 8 weeks, participants will wear their assigned splints and attend follow-up assessments. The study's primary outcome is to measure changes in mandibular movement patterns using MODJAW. Secondary outcomes include reduction in TMJ pain, patient-reported satisfaction and comfort, and any adverse events related to splint use.

Official TitlePatient-Specific Occlusal Splints Designed Using MODJAW Kinematic Data: A Prospective Clinical Study
Principal SponsorIstanbul University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorBruxismHabitsStomatognathic DiseasesTooth Diseases

Criteria

Inclusion Criteria: * 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 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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Group II

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Istanbul university

Istanbul, Turkey (Türkiye)Open Istanbul university in Google Maps
CompletedOne Study Center