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

NCT06487819 | Not Yet Recruiting DMC

• 1 other identifier: AUAREC202400002-16
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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?

Conditions

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

Outcome Measures

Primary Outcomes (5)

• Interincisal Distance

  Measurement of the distance from the incisal edge of upper incisors to the incisal edge of lower incisors when the mouth is opened maximally in mm.

  Preoperative, immediately postoperative, 2 weeks postoperative.

• Occlusal Biting Force

  measurement of the biting force exerted by the patient's occlusion. This will be measured using a bite force gauge or similar instrument at the specified time points.

  Preoperative, immediately postoperative, 2 weeks postoperative.

• Visual Analogue Scale (VAS)

  A subjective measure of pain intensity experienced by the patient. Patients will mark their pain level on a scale from 0 (no pain) to 10 (worst pain imaginable).

  Preoperative, immediately postoperative, 2 weeks postoperative.

• Magnetic Resonance Imaging (MRI)

  MRI scans will be done for patients who exhibit signs and symptoms of TMD postoperatively.

  2 weeks postoperative (for symptomatic patients).

• Lateral Excursion Movement

  The maximum amount of lateral excursion on each side will be measured in mm.

  Preoperative, immediately postoperative, 2 weeks postoperative.

Secondary Outcomes (1)

• Optimal Duration for Rubber Dam Use

  immediately postoperative

Study Arms (3)

Group 1 - Short Duration Rubber Dam Application

EXPERIMENTAL

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.

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

Group 2 - Medium Duration Rubber Dam Application

EXPERIMENTAL

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.

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

Group 3 - Long Duration Rubber Dam Application

EXPERIMENTAL

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.

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

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).

Group 1 - Short Duration Rubber Dam Application; Group 2 - Medium Duration Rubber Dam Application; Group 3 - Long Duration Rubber Dam Application

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged from 18 - 40 years old of both sexes.
• No evidence of bad habits that affect occlusion like bruxism or clenching.
• Patient with normal occlusion.
• Patient free of any signs and symptoms of TMD and myofascial pain.
• Normal range of TMJ movements.
• Normal biting force.

You may not qualify if:

• Patient with systemic or local diseases that can affect TMJ like osteoarthritis, rheumatoid arthritis, or systemic lupus erythema.
• Patient with trismus.
• Patient with Recurrent dislocation of TMJ.
• Swelling affects mouth opening.
• Patient came with TMJ ankylosis.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

‪Ahmed Sabry‬

Asyut, Assuit, Egypt

Location

Related Publications (9)

• 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.

  PMID: 37510548 BACKGROUND

• 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.

  PMID: 23809304 BACKGROUND

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

  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.

  PMID: 10519741 BACKGROUND

• 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.

  PMID: 17082281 BACKGROUND

• 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.

  PMID: 22991607 BACKGROUND

• 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.

  PMID: 39043507 BACKGROUND

• 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.

  PMID: 37654409 BACKGROUND

• 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.

  PMID: 2760346 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis; Facial Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• ‪Ahmed Sabry‬

  Al-Azhar University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

‪Ahmed Sabry‬

CONTACT

+201144795829; sabry98939@dent.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Oral and Maxillofacial Surgery

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: July 5, 2024
• Study Start: August 10, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)