Patient-Specific Occlusal Splints Using MODJAW Kinematics (MOD-SP)

January 21, 2026 updated by: Dr. Merve Benli, Istanbul University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MODJAW-Based Patient-Specific Splint
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
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.
Experimental: Standard Occlusal Splint
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
A conventional occlusal splint made using standard methods without patient-specific mandibular movement data. Worn nightly (or per instructions) for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Improvement in mandibular movement patterns
Time Frame: Baseline and after 8 weeks of splint use

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
TMJ pain levels
Time Frame: Baseline and after 8 weeks of splint use
Patients pain levels will be assessed using a Visual Analog Scale (VAS).
Baseline and after 8 weeks of splint use
Comfort and satisfaction
Time Frame: Baseline and after 8 weeks of splint use
Patient comfort and satisfaction will be assessed using a patient-reported questionnaire and 5-point Likert scale.
Baseline and after 8 weeks of splint use

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 25, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • U-116S697

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Individual participant data (IPD) from this study will not be shared. The study involves patient-specific dental records and intraoral imaging that are considered sensitive and personally identifiable. To protect participant privacy and comply with ethical standards, raw data containing personal identifiers will remain confidential and will not be made publicly available. Aggregate or de-identified summary data may be shared upon reasonable request with qualified researchers following approval from the study team and institutional review board.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Dietary Supplements

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