Diacutaneus Fibrolysis on Tempromandibular Joint Pain and Trismus Post Oral Surgery

February 27, 2025 updated by: Aliaa Elsayed Ali, Cairo University

Effect of Diacutaneus Fibrolysis on Tempromandibular Joint Pain and Trismus Post Oral and Maxillofacial Surgery

This study is carried out on sixty patients who will have tempromandibular pain and trismuspostOral and Maxillofacial Surgeryand their ages will be ranged from 18 to 40 years.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt, 12613
        • Cairo university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Ages of patients will be ranged from 18 to 40 years.
  2. All patients will have Oral and Maxillofacial Surgery.
  3. All patients will be referred by a surgeon before starting the study procedure.
  4. All participants will have pain and trismus in the jaw,
  5. The participants will be also cleared for periodontal issues.
  6. All patients will enter the study having their informed consent

Exclusion Criteria:

  1. Patients with associated vascular injuries requiring arterial repair.
  2. Patient with systemic diseases such as arthritis; pain attributable to confirmed migraine, head, or neck pain condition
  3. Patient with acute infection or other significant disease of the teeth, ears, eyes, nose, or throat
  4. Patient with present neurologic or cognitive deficit.
  5. Patients with history of previously failed surgeries.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group B
This group includes 30 patients who will receive 4 weeks(3times/week) DiacutaneusFibrolysis in addition to post-surgical traditional physiotherapy .
Device: Diacutaneus fibrolysis
Material : Stainless steel large angle and small long angle: length 22cm x height 6cm x width 2cm. Weight: 70 grams
Other Names:
  • Hook measurements
Procedure: Massage
manual therapy intervention
Device: Transcutaneous electrical nerve stimulation
physical therapy electrical modality
Other Names:
  • TENS
Placebo Comparator: Group A
This group will includes 30 patients who will receive 4 weeks (3times/week) post-surgical traditional physiotherapy (TENS , massage , range of motion exercise ) .
Procedure: Massage
manual therapy intervention
Device: Transcutaneous electrical nerve stimulation
physical therapy electrical modality
Other Names:
  • TENS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
temporomandibular joint pain
Time Frame: pre intervention and re assessed after 1 month
pain is assessed Pressure pain threshold(PPT) will be obtained with the aid of an algometer by applying pressure to the masseter and to the anterior, middle, and posterior temporalis, increasing pressure until the patient will feel that the pressure will become unpleasant or "painful .
pre intervention and re assessed after 1 month
Trismus
Time Frame: pre intervention and re assessed after 1 month
Trismus is assessed by caliper
pre intervention and re assessed after 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2024

Primary Completion (Actual)

September 20, 2024

Study Completion (Actual)

February 27, 2025

Study Registration Dates

First Submitted

November 4, 2024

First Submitted That Met QC Criteria

November 4, 2024

First Posted (Actual)

November 5, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 27, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 012/005335

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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