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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorAl-Azhar University

About this trial

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?

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Procedure/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).

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: Group 1 - Short Duration Rubber Dam ApplicationExperimental treatment 1 intervention
Group B: Group 2 - Medium Duration Rubber Dam ApplicationExperimental treatment 1 intervention
Group C: Group 3 - Long Duration Rubber Dam ApplicationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Preoperative, immediately postoperative, 2 weeks postoperative.
2

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.

Time frame
Preoperative, immediately postoperative, 2 weeks postoperative.
3

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).

Time frame
Preoperative, immediately postoperative, 2 weeks postoperative.
4

Magnetic Resonance Imaging (MRI)

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

Time frame
2 weeks postoperative (for symptomatic patients).

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 .

Time frame
immediately postoperative

Other outcomes

Sponsors and contacts

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