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

Al-Azhar University

Status: Not yet enrolling

Conditions: TMJ Disc Disorder; Osteoarthritis; Myofacial Pain; Temporomandibular Joint Condition Post Longstanding Mouth Opening During Dental Procedure Using Rubber Dam

Treatments: Procedure: Application of a rubber dam during dental treatments for varying durations.

Study type: Interventional

Funder types: Other

Identifiers

NCT06487819

AUAREC202400002-16

Details and patient eligibility

About

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?

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 3 patient groups

Group 1 - Short Duration Rubber Dam Application

Experimental group

Description:

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.

Treatment:

Procedure: Application of a rubber dam during dental treatments for varying durations.

Group 2 - Medium Duration Rubber Dam Application

Experimental group

Description:

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.

Treatment:

Procedure: Application of a rubber dam during dental treatments for varying durations.

Group 3 - Long Duration Rubber Dam Application

Experimental group

Description:

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.

Treatment:

Procedure: Application of a rubber dam during dental treatments for varying durations.