Not yet recruiting NCT06487819
Evaluation of Temporomandibular Joint Condition Post Longstanding Mouth Opening by Rubber Dam
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Application of a rubber dam during dental treatments for varying durations..
- Who it may be relevant to
- Registry conditions: Temporomandibular Joint Condition Post Longstanding Mouth Opening During Dental Procedure Using Rubber Dam, TMJ Disc Disorder, Osteoarthritis, Myofacial Pain. Basic parameters: 18 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of Temporomandibular Joint Condition Post Longstanding Mouth Opening by Rubber Dam (A Clinical and Radiographic Study)
Overview
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?
Interventions
- Procedure 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).
Primary outcome measures
- Interincisal Distance [Time frame: Preoperative, immediately postoperative, 2 weeks postoperative.]
- Occlusal Biting Force [Time frame: Preoperative, immediately postoperative, 2 weeks postoperative.]
- Visual Analogue Scale (VAS) [Time frame: Preoperative, immediately postoperative, 2 weeks postoperative.]
- Magnetic Resonance Imaging (MRI) [Time frame: 2 weeks postoperative (for symptomatic patients).]
- Lateral Excursion Movement [Time frame: Preoperative, immediately postoperative, 2 weeks postoperative.]
Secondary outcome measures (1)
- Optimal Duration for Rubber Dam Use [Time frame: immediately postoperative]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Screening
Study locations
Egypt · 1 center
- Ahmed Sabry — Asyut
Publications
- 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
- 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
- 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. PMID 10519741
- 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
- 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
- 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
- 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
Identifiers
NCT: NCT06487819 · AUAREC202400002-16