Evaluation of Temporomandibular Joint Condition Post Longstanding Mouth Opening by Rubber Dam

Not Applicable

Not yet recruiting

• Conditions: TMJ Disc Disorder; Temporomandibular Joint Condition Post Longstanding Mouth Opening During Dental Procedure Using Rubber Dam; Osteoarthritis; Myofacial Pain
• Interventions: Procedure: Application of a rubber dam during dental treatments for varying durations.

• Registration Number: NCT06487819
• Lead Sponsor: Al-Azhar University

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?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-19
• Study First Submitted QC: 2024-06-27
• Study First Posted: 2024-07-05
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-18
• Study Start: 2025-08-10
• Primary Completion: 2026-05-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2 - Medium Duration Rubber Dam Application	Application of a rubber dam during dental treatments for varying durations.	Patients undergoing dental procedures with rubber dam isolation for 60 to 90 minutes. This group will help evaluate the effects of medium-term mouth opening on TMJ condition.
Group 1 - Short Duration Rubber Dam Application	Application of a rubber dam during dental treatments for varying durations.	Patients undergoing dental procedures with rubber dam isolation for 30 to 60 minutes. This group will help assess the impact of short-term mouth opening on temporomandibular joint (TMJ) condition.
Group 3 - Long Duration Rubber Dam Application	Application of a rubber dam during dental treatments for varying durations.	Patients undergoing dental procedures with rubber dam isolation for more than 90 minutes. This group will provide insights into the impact of long-term mouth opening on TMJ condition.

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS)	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	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	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)	2 weeks postoperative (for symptomatic patients).	MRI scans will be done for patients who exhibit signs and symptoms of TMD postoperatively.
Lateral Excursion Movement	Preoperative, immediately postoperative, 2 weeks postoperative.	The maximum amount of lateral excursion on each side will be measured in mm.

Secondary Outcome Measures

Name	Time	Method
Optimal Duration for Rubber Dam Use	immediately postoperative	measure the duration of time for rubber dam application from the beginning of rubber dam application till the dentist remove rubber dam from the mouth of patient .

Trial Locations

Locations (1)

‪Ahmed Sabry‬; 🇪🇬 Assiut, Assuit, Egypt