Adjustment Technique for Occlusal Stabilizing Splint

February 6, 2026 updated by: Mai Ahmed Haggag, Mansoura University

Adjustment Technique for Occlusal Stabilizing Splint Used in Temporomandibular Disorders. A Clinical Guide

This study aims to clarify the technique of occlusal stabilizing splint adjustment then to assess the overall clinical outcomes and patient satisfaction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

It is reasonable to highlight the occlusal stabilizing splint adjustment protocol as it is important to achieve TMDs' sign and symptom relief. Therefore, the objective of this study is to explain in detail how to adjust the occlusal stabilizing splint properly, as we found few studies that clarify the exact adjustment protocol.

Study Type

Interventional

Enrollment (Actual)

800

Phase

  • 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

  • Egypt
      • Al Mansurah, Egypt
        • Faculty of Dentistry - Mansoura University

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

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pain in the orofacial region (either arthrogenous and/or myogenous) in the last 3 months, who never underwent any type of treatment for TMD's.
  • Patients with TMJ internal derangement.
  • Age ≥16 years.

Exclusion Criteria:

  • Edentulous patients.
  • Patients with any systemic disease that could cause joint and/or muscle changes.
  • Patients who undergo drug treatment for the condition.
  • Current pregnancy or breastfeeding.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stabilizing Splint (3-point of Contact)
Stabilizing Splints were adjusted only in centric relation with at least 3-point of contact
Device: Stabilizing Splint(3-point of Contact)
These devices are also known as flat plane, inter-occlusal splint, or myo relaxation splint, and are used not only to stabilize the TMJ but also protect the teeth, relax masser etand temporalis muscles, increase inter-discal space, allow the balance of bite forces, and decrease bruxism activity.
Experimental: Stabilizing Splint (Centric and Eccentric)
Stabilizing Splints were adjusted in centric relation and in all eccentric movements
Device: Stabilizing Splint (Centric and Eccentric)
Stabilizing Splint (Centric and Eccentric)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Patient Satisfaction
Time Frame: 6 months after using the stabilizing splint
Using PSPSQ Questionnaire (The patient satisfaction questionnaire comprised three questions assessed using 10-point Likert Scale)
6 months after using the stabilizing splint

Collaborators and Investigators

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

Sponsor

Mansoura University

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)

June 1, 2025

Primary Completion (Actual)

September 1, 2025

Study Completion (Actual)

January 15, 2026

Study Registration Dates

First Submitted

February 2, 2026

First Submitted That Met QC Criteria

February 6, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R.26.01.97

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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