Adjustment Technique for Occlusal Stabilizing Splint

NCT07397013 | Completed DMC

• 1 other identifier: R.26.01.97
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myogenic Temporomandibular Joint Disorders; Internal Derangement of the Tempromandibular Joint; Temporomandibular Disorders (TMDs); Temporomandibular Joint Disc Displacement

Keywords

TMDs; Myogenic Pain; Intraarticular Pain; Disc Displacement; Stabilizing Splint

Outcome Measures

Primary Outcomes (1)

• Overall Patient Satisfaction

  Using PSPSQ Questionnaire (The patient satisfaction questionnaire comprised three questions assessed using 10-point Likert Scale)

  6 months after using the stabilizing splint

Study Arms (2)

Stabilizing Splint (3-point of Contact)

EXPERIMENTAL

Stabilizing Splints were adjusted only in centric relation with at least 3-point of contact

Device: Stabilizing Splint(3-point of Contact)

Stabilizing Splint (Centric and Eccentric)

EXPERIMENTAL

Stabilizing Splints were adjusted in centric relation and in all eccentric movements

Device: Stabilizing Splint (Centric and Eccentric)

Interventions

Stabilizing Splint(3-point of Contact) DEVICE

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.

Stabilizing Splint (3-point of Contact)

Stabilizing Splint (Centric and Eccentric) DEVICE

Stabilizing Splint (Centric and Eccentric)

Stabilizing Splint (Centric and Eccentric)

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Dentistry - Mansoura University

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 9, 2026
• Study Start: June 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: January 15, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)