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NCT Number: NCT06487819

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

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?

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Key information

Conditions

Temporomandibular Joint Condition Post Longstanding Mouth Opening During Dental Procedure Using Rubber Dam Arthritis Facial Pain Joint Diseases Musculoskeletal Diseases Myofacial Pain Neurologic Manifestations Osteoarthritis Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms TMJ Disc Disorder

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

‪Ahmed Sabry‬

Asyut, Assuit, Egypt

Location contact

Al_Azhar university

CONTACT

‪Ahmed Sabry‬

CONTACT

[email protected]

+201144795829 ext. Sabry‬

‪Ahmed Sabry‬

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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.

Secondary outcomes

  1. Optimal Duration for Rubber Dam Use

    Time frame: immediately postoperative

    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 .

Study contacts

Contact information is provided by the study sponsor or research team.

‪Ahmed Sabry‬

CONTACT

[email protected]

+201144795829

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 5, 2024
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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