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

Sponsor
Al-Azhar University
Study ID
NCT06487819
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • Application of a rubber dam during dental treatments for varying durations. — PROCEDURE
    Patients in each group will undergo dental procedures (either operative or endodontic treatment) with rubber dam isolation. The rubber dam will be applied for the specific durations mentioned in each group to evaluate the impact of mouth opening on the temporomandibular joint (TMJ).

Study Details

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?

Key Dates

First listed
Jul 5, 2024
Start date
Aug 10, 2025
Status verified
Feb 2025
Primary completion
May 1, 2026
Completion
Jul 1, 2026

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Experimental: Group 1 - Short Duration Rubber Dam Application
    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.
  • Experimental: Group 2 - Medium Duration Rubber Dam Application
    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.
  • Experimental: Group 3 - Long Duration Rubber Dam Application
    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 Measure

Interincisal Distance [ Time Frame: Preoperative, immediately postoperative, 2 weeks postoperative. ]

Central Contacts

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