Temporomandibular Joint Condition Post Longstanding Mouth Opening During Dental Procedure Using Rubber DamNCT06487819
Evaluation of Temporomandibular Joint Condition Post Longstanding Mouth Opening by Rubber Dam
A study testing Application of a rubber dam during dental treatments for varying durations. in people with Temporomandibular Joint Condition Post Longstanding Mouth Opening During Dental Procedure Using Rubber Dam and TMJ Disc Disorder, run by Al-Azhar University at 1 site in Egypt.
Trial 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 … Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Condition Post Longstanding Mouth Opening During Dental Procedure Using Rubber Dam, TMJ Disc Disorder, Osteoarthritis
- What is being tested?
- Application of a rubber dam during dental treatments for varying durations.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Ahmed Sabry
Asyut, Assuit
Al_Azhar university
Ahmed Sabry, +201144795829 ext. Sabry, sabry98939@dent.aun.edu.eg
About this study
Official title: Evaluation of Temporomandibular Joint Condition Post Longstanding Mouth Opening by Rubber Dam (A Clinical and Radiographic Study)
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
- Being tested
- Application of a rubber dam during dental treatments for varying durations.
- Medical subject headings
- Osteoarthritis, Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of a rubber dam during dental treatments for varying durations.Procedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Application of a rubber dam during dental treatments for varying durations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 2 weeks postoperative (for symptomatic patients).
Lateral Excursion Movement
The maximum amount of lateral excursion on each side will be measured in mm.
Measured: Preoperative, immediately postoperative, 2 weeks postoperative.
Secondary outcomes (1)
Optimal Duration for Rubber Dam Use
measure the duration of time for rubber dam application from the beginning of rubber dam application till the dentist remove rubber dam from the mouth of patient .
Measured: immediately postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start10 Aug 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint Condition Post Longstanding Mouth Opening During Dental Procedure Using Rubber DamStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Sabry, Al-Azhar University
- Investigators
- Ahmed Sabry, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487819
- Sponsor's protocol ID
- AUAREC202400002-16
- Status last verified
- Feb 2025
- First submitted
- 19 Jun 2024
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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.
PubMed 37510548Liu 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.
PubMed 238093043. 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.
PubMed 10519741Huang 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.
PubMed 17082281Sahebi 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.
PubMed 22991607Nasef 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.
PubMed 39043507Tiwari 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.
PubMed 37654409Cochran 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.
PubMed 2760346
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Temporomandibular Joint Condition Post Longstanding Mouth Opening by Rubber Dam (A Clinical and Radiographic Study)
- ClinicalTrials.gov ID
- NCT06487819
- Acronym / sponsor ID
- AUAREC202400002-16
- Conditions
- Temporomandibular Joint Condition Post Longstanding Mouth Opening During Dental Procedure Using Rubber Dam, TMJ Disc Disorder, Osteoarthritis, Myofacial Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 10 Aug 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Short Duration Rubber Dam Application | Experimental | Procedure: Application of a rubber dam during dental treatments for varying durations.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 2 - Medium Duration Rubber Dam Application | Experimental | Procedure: Application of a rubber dam during dental treatments for varying durations.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 3 - Long Duration Rubber Dam Application | Experimental | Procedure: Application of a rubber dam during dental treatments for varying durations.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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Procedure or surgery | Group 1 - Short Duration Rubber Dam Application, Group 2 - Medium Duration Rubber Dam Application, Group 3 - Long Duration Rubber Dam Application |
Primary outcome
Interincisal Distance
Time frame: Preoperative, immediately postoperative, 2 weeks postoperative.
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.
Occlusal Biting Force
Time frame: Preoperative, immediately postoperative, 2 weeks postoperative.
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.
Visual Analogue Scale (VAS)
Time frame: Preoperative, immediately postoperative, 2 weeks postoperative.
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).
Magnetic Resonance Imaging (MRI)
Time frame: 2 weeks postoperative (for symptomatic patients).
MRI scans will be done for patients who exhibit signs and symptoms of TMD postoperatively.
Lateral Excursion Movement
Time frame: Preoperative, immediately postoperative, 2 weeks postoperative.
The maximum amount of lateral excursion on each side will be measured in mm.
1 secondary outcome
Optimal Duration for Rubber Dam Use
Time frame: immediately postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Background: PubMed 37510548Wang 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.
- Background: PubMed 23809304Liu 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.
- Background3. Okeson JP. Management of Temporomandibular Disorders and Occlusion. 5th ed. Louis: Mosby; 2003.
- Background: PubMed 10519741Goldstein 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.
- Background: PubMed 17082281Huang 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.
- Background: PubMed 22991607Sahebi 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.
- Background: PubMed 39043507Nasef 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.
- Background: PubMed 37654409Tiwari 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.
- Background: PubMed 2760346Cochran 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.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahmed Sabry principal investigator
Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application of a rubber dam during dental treatments for varying durations. in people with Temporomandibular Joint Condition Post Longstanding Mouth Opening During Dental Procedure Using Rubber Dam and TMJ Disc Disorder, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Sabry (+201144795829, sabry98939@dent.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interincisal Distance (time frame: Preoperative, immediately postoperative, 2 weeks postoperative.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06487819, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.