A Comparative Study Between the Different Levels of TMJ Arthroscopy in the Management of TMJ Internal Derangement
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ClinicalTrials.gov Identifier: NCT06013059 |
Recruitment Status :
Completed
First Posted : August 28, 2023
Last Update Posted : October 10, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
TMJ Disc Disorder | Procedure: three levels of TMJ arthroscopy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | A Comparative Study Between the Different Levels of TMJ Arthroscopy in the Management of TMJ Internal Derangement (A Randomized Clinical Trial) |
Actual Study Start Date : | June 1, 2021 |
Actual Primary Completion Date : | December 1, 2022 |
Actual Study Completion Date : | July 30, 2023 |
Arm | Intervention/treatment |
---|---|
Active Comparator: level (I) arthroscopy (Lysis and lavage) |
Procedure: three levels of TMJ arthroscopy
Group I: 10 patients will be treated with Lysis and lavage |
Active Comparator: level (II) arthroscopy (operative arthroscopy) |
Procedure: three levels of TMJ arthroscopy
Group II: 10 patients will be treated with operative arthroscopy |
Active Comparator: level (III) arthroscopy (operative arthroscopy + disc repositioning and fixation) |
Procedure: three levels of TMJ arthroscopy
Group III: 10 patients will be treated with operative arthroscopy + discopexy |
- Mouth opening measurement [ Time Frame: 1, 3 and 6 months postoperatively ]measuring the maximal interincisal opening (MIO)
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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with TMJ internal derangement Wilkes III
Exclusion Criteria:
- Medically unfit patients.
- Patients with TMDs secondary to malocclusion.
- Psychological instability.
- Patients operated before for other TMJ problems.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06013059
Egypt | |
Alexandria University | |
Alexandria, Egypt |
Principal Investigator: | Mohamed Fayad, MD | Alexandria University |
Documents provided by Mohamed Hamza Fayad, Alexandria University:
Responsible Party: | Mohamed Hamza Fayad, Assistant lecturer, Alexandria University |
ClinicalTrials.gov Identifier: | NCT06013059 |
Other Study ID Numbers: |
001056 - IORG 0008839 |
First Posted: | August 28, 2023 Key Record Dates |
Last Update Posted: | October 10, 2023 |
Last Verified: | October 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |