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Clinical Trials/NCT06487819
NCT06487819
Not Yet Recruiting
N/A

Evaluation of Temporomandibular Joint Condition Post Longstanding Mouth Opening by Rubber Dam (A Clinical and Radiographic Study)

Al-Azhar University1 site in 1 country300 target enrollmentAugust 10, 2025

Overview

Phase
N/A
Intervention
Not specified
Conditions
Temporomandibular Joint Condition Post Longstanding Mouth Opening During Dental Procedure Using Rubber Dam
Sponsor
Al-Azhar University
Enrollment
300
Locations
1
Primary Endpoint
Visual Analogue Scale (VAS)
Status
Not Yet Recruiting
Last Updated
last year

Overview

Brief Summary

This Clinical and radiographic study will be designed to evaluate the temporomandibular joint condition post longstanding mouth opening during dental procedure using rubber dam. primary outcome : preoperative and postoperative assessment of interincisal distance , occlusal biting force , visual analogue scale , lateral excursion movement and Magnetic resonance imaging (MRI).

Secondary outcome: investigator will try to answer the question of what is the best duration of time could the dentist use rubber dam isolation in dental procedures without harmful effect on TMJ and its supporting structures?

Registry
clinicaltrials.gov
Start Date
August 10, 2025
End Date
July 1, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

‪Ahmed Sabry‬

Resident at Oral and Maxillofacial Surgery

Al-Azhar University

Eligibility Criteria

Inclusion Criteria

  • Patients aged from 18 - 40 years old of both sexes.
  • No evidence of bad habits that affect occlusion like bruxism or clenching.
  • Patient with normal occlusion.
  • Patient free of any signs and symptoms of TMD and myofascial pain.
  • Normal range of TMJ movements.
  • Normal biting force.

Exclusion Criteria

  • Patient with systemic or local diseases that can affect TMJ like osteoarthritis, rheumatoid arthritis, or systemic lupus erythema.
  • Patient with trismus.
  • Patient with Recurrent dislocation of TMJ.
  • Swelling affects mouth opening.
  • Patient came with TMJ ankylosis.

Outcomes

Primary Outcomes

Visual Analogue Scale (VAS)

Time Frame: Preoperative, immediately postoperative, 2 weeks postoperative.

A subjective measure of pain intensity experienced by the patient. Patients will mark their pain level on a scale from 0 (no pain) to 10 (worst pain imaginable).

Interincisal Distance

Time Frame: Preoperative, immediately postoperative, 2 weeks postoperative.

Measurement of the distance from the incisal edge of upper incisors to the incisal edge of lower incisors when the mouth is opened maximally in mm.

Occlusal Biting Force

Time Frame: Preoperative, immediately postoperative, 2 weeks postoperative.

measurement of the biting force exerted by the patient's occlusion. This will be measured using a bite force gauge or similar instrument at the specified time points.

Magnetic Resonance Imaging (MRI)

Time Frame: 2 weeks postoperative (for symptomatic patients).

MRI scans will be done for patients who exhibit signs and symptoms of TMD postoperatively.

Lateral Excursion Movement

Time Frame: Preoperative, immediately postoperative, 2 weeks postoperative.

The maximum amount of lateral excursion on each side will be measured in mm.

Secondary Outcomes

  • Optimal Duration for Rubber Dam Use(immediately postoperative)

Study Sites (1)

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