Evaluation of Temporomandibular Joint Condition Post Longstanding Mouth Opening by Rubber Dam
NCT ID: NCT06487819
Last Updated: 2025-02-18
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
300 participants
INTERVENTIONAL
2025-08-10
2026-07-01
Brief Summary
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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?
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
QUADRUPLE
Study Groups
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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.
Application of a rubber dam during dental treatments for varying durations.
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).
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.
Application of a rubber dam during dental treatments for varying durations.
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).
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.
Application of a rubber dam during dental treatments for varying durations.
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).
Interventions
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Application of a rubber dam during dental treatments for varying durations.
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).
Eligibility Criteria
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Inclusion Criteria
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
2. Patient with trismus.
3. Patient with Recurrent dislocation of TMJ.
4. Swelling affects mouth opening.
5. Patient came with TMJ ankylosis.
18 Years
40 Years
ALL
Yes
Sponsors
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Al-Azhar University
OTHER
Responsible Party
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Ahmed Sabry
Resident at Oral and Maxillofacial Surgery
Principal Investigators
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Ahmed Sabry
Role: PRINCIPAL_INVESTIGATOR
Al-Azhar University
Locations
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Ahmed Sabry
Asyut, Assuit, Egypt
Countries
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Central Contacts
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Facility Contacts
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Al_Azhar university
Role: primary
References
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Wang Q, Jia J, Zhou C, Ye W, Bi R. A Bibliometric Analysis of Research on Temporomandibular Joint Disc Displacement from 1992 to 2022. Healthcare (Basel). 2023 Jul 24;11(14):2108. doi: 10.3390/healthcare11142108.
Liu F, Steinkeler A. Epidemiology, diagnosis, and treatment of temporomandibular disorders. Dent Clin North Am. 2013 Jul;57(3):465-79. doi: 10.1016/j.cden.2013.04.006.
3. Okeson JP. Management of Temporomandibular Disorders and Occlusion. 5th ed. Louis: Mosby; 2003.
Goldstein BH. Temporomandibular disorders: a review of current understanding. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1999 Oct;88(4):379-85. doi: 10.1016/s1079-2104(99)70048-x.
Huang GJ, Rue TC. Third-molar extraction as a risk factor for temporomandibular disorder. J Am Dent Assoc. 2006 Nov;137(11):1547-54. doi: 10.14219/jada.archive.2006.0090.
Sahebi S, Moazami F, Afsa M, Nabavi Zade MR. Effect of lengthy root canal therapy sessions on temporomandibular joint and masticatory muscles. J Dent Res Dent Clin Dent Prospects. 2010 Summer;4(3):95-7. doi: 10.5681/joddd.2010.024. Epub 2010 Sep 16.
Nasef M, Alashmawy M, Abdelrahman A, Elsaid M, Elwaseef S, Mohamed A. Evaluation of intra-articular injection of injectable platelet-rich fibrin, anterior repositioning splint and arthrocentesis in treatment of temporomandibular joint internal derangement. Br J Oral Maxillofac Surg. 2024 Oct;62(8):710-715. doi: 10.1016/j.bjoms.2024.05.002. Epub 2024 May 20.
Tiwari RVC, Managutti A, Lakshmi DP, Mohindru K, Damarasingu R, Dubey A. Isolation Systems and its Effectiveness in Oral and Maxillofacial Surgery: A Systematic Review. J Pharm Bioallied Sci. 2023 Jul;15(Suppl 1):S79-S85. doi: 10.4103/jpbs.jpbs_518_22. Epub 2023 Jul 5.
Cochran MA, Miller CH, Sheldrake MA. The efficacy of the rubber dam as a barrier to the spread of microorganisms during dental treatment. J Am Dent Assoc. 1989 Jul;119(1):141-4. doi: 10.14219/jada.archive.1989.0131.
Other Identifiers
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AUAREC202400002-16
Identifier Type: -
Identifier Source: org_study_id
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