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

Evaluation of Temporomandibular Joint Condition Post Longstanding Mouth Opening by Rubber Dam (A Clinical and Radiographic Study)

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06487819
Enrollment
300
Registered
2024-07-05
Start date
2025-08-10
Completion date
2026-07-01
Last updated
2025-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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?

Interventions

PROCEDUREApplication 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).

Sponsors

Al-Azhar University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Interincisal DistancePreoperative, 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 ForcePreoperative, 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)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)2 weeks postoperative (for symptomatic patients).MRI scans will be done for patients who exhibit signs and symptoms of TMD postoperatively.
Lateral Excursion MovementPreoperative, immediately postoperative, 2 weeks postoperative.The maximum amount of lateral excursion on each side will be measured in mm.

Secondary

MeasureTime frameDescription
Optimal Duration for Rubber Dam Useimmediately postoperativemeasure 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 .

Countries

Egypt

Contacts

Primary Contact‪Ahmed Sabry‬
sabry98939@dent.aun.edu.eg+201144795829

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026