Clinical trial NCT06487819: Evaluation of Temporomandibular Joint Condition Post Longstanding Mouth Opening by Rubber Dam
Official title: Evaluation of Temporomandibular Joint Condition Post Longstanding Mouth Opening by Rubber Dam (A Clinical and Radiographic Study)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Temporomandibular Joint Condition Post Longstanding Mouth Opening During Dental Procedure Using Rubber Dam
TMJ Disc Disorder
Osteoarthritis
Myofacial Pain
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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?


Eligibility criteria: 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.

Primary outcomes:
measure: Interincisal Distance
timeFrame: Preoperative, immediately postoperative, 2 weeks postoperative.
measure: Occlusal Biting Force
timeFrame: Preoperative, immediately postoperative, 2 weeks postoperative.
measure: Visual Analogue Scale (VAS)
timeFrame: Preoperative, immediately postoperative, 2 weeks postoperative.
measure: Magnetic Resonance Imaging (MRI)
timeFrame: 2 weeks postoperative (for symptomatic patients).
measure: Lateral Excursion Movement
timeFrame: Preoperative, immediately postoperative, 2 weeks postoperative.
Secondary outcomes:
measure: Optimal Duration for Rubber Dam Use
timeFrame: immediately postoperative
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: ‪Ahmed Sabry‬
state: Assuit
Study officials:
affiliation: Al-Azhar University
name: ‪Ahmed Sabry‬
role: PRINCIPAL_INVESTIGATOR
References:
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