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

NCT ID: NCT06487819

Last Updated: 2025-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-10

Study Completion Date

2026-07-01

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Group Type EXPERIMENTAL

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

Intervention Type 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).

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.

Group Type EXPERIMENTAL

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

Intervention Type 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).

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.

Group Type EXPERIMENTAL

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

Intervention Type 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).

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).

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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‪Ahmed Sabry‬

Resident at Oral and Maxillofacial Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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‪Ahmed Sabry‬

Role: PRINCIPAL_INVESTIGATOR

Al-Azhar University

Locations

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‪Ahmed Sabry‬

Asyut, Assuit, Egypt

Site Status

Countries

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Egypt

Central Contacts

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‪Ahmed Sabry‬

Role: CONTACT

+201144795829

Facility Contacts

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Al_Azhar university

Role: primary

‪Ahmed Sabry‬

Role: backup

+201144795829 ext. Sabry‬

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.

Reference Type BACKGROUND
PMID: 37510548 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23809304 (View on PubMed)

3. Okeson JP. Management of Temporomandibular Disorders and Occlusion. 5th ed. Louis: Mosby; 2003.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 10519741 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17082281 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22991607 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39043507 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37654409 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2760346 (View on PubMed)

Other Identifiers

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AUAREC202400002-16

Identifier Type: -

Identifier Source: org_study_id

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