Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202303632334777 Date of Approval: 20/03/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Arthroscopic assisted release of lateral pterygoid versus scarification of retrodiscal tissue in management of internal derangement of temporomandibular joint: RCT
Official scientific title Arthroscopic assisted release of lateral pterygoid versus scarification of retrodiscal tissue in management of internal derangement of temporomandibular joint: A randomized control trial
Brief summary describing the background and objectives of the trial Temporomandibular joints are bilateral, diarthroidal, synovial and freely movable. The joints has two articulating bone components the mandibular condyle inferiorly and the articular eminence and glenoid fossa of the temporal bone superiorly interposed by disc. The most common TMJ disorder is the internal derangement due to abnormal relationship among the mandibular condyle, articular eminence and articular disc. More than 80% of patients with ID of the TMJ can be treated successfully with non- surgical therapy in the form of pharmacologic approaches, physical medicine, oral appliances, and management of the occlusion are applied before considering surgical treatment15. Patients who do not respond to conservative therapy may require more invasive procedures, such as disc repositioning by excision of retrodiscal tissue and intra- articular suturing and disc repair, discectomy or discectomy and replacement. McCain developed a procedure to scar the stratum inferior. He found that a scar contracture was effective to reduce the motion of the disc. Retrodiscal tissue is contracted using bipolar cautery, laser, or ArthroCare. The target area of the retrodiscal contracture is generally the redundant synovium found lateral to the oblique protuberance. Low voltage laser, bipolar, or ArthroCare is used to weld that tissue, accomplishing synovectomy superficially and then penetrating deeper into the bilaminar zone, causing scar contracture. Contracture is visible during the procedure, but the most significant contracture occurs 2 to 3 weeks postoperatively as the scar thickens. The purpose of the contracture is to enhance the posterior positioning of the disc and hold it there. The aim of this study is to compare arthroscopic assisted release of lateral pterygoid muscle versus retrodiscal scarification in the treatment of internal derangement of temporomandibular joint clinically and by magnetic resonance imaging.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/06/2019
Actual trial start date 01/06/2019
Anticipated date of last follow up 31/01/2022
Actual Last follow-up date 31/07/2022
Anticipated target sample size (number of participants) 16
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL N/A
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Arthroscopic assisted release N/A N/A The terminal end of diatherm was introduced through a second cannula. Once the purple shadow of the lateral pterygoid muscle were visualized, the myotomy is done using the diatherm to allows safe coagulation of the bleeding vessels. 8
Control Group scarification of the retrodiscal tissues N/A N/A The target area of the retrodiscal tissues is generally the redundant synovium found lateral to the oblique protuberance. Bipolar diatherm is used to weld that tissue, accomplishing synovectomy superficially and then penetrating deeper into the bilaminar zone, causing scar contracture. 8 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Patients who failed to respond to conservative management protocol (non-steroidal anti-inflammatory drugs, physiotherapy, and occlusal splint) for three months. - Wilkes stage II, III. - No prior TMJ surgery. - An inflammatory or connective tissue disease. - History of or an ongoing autoimmune disease. - Neurologic disorders. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/05/2021 Research Ethics Committee Faculty of Dentistry Tanta University
Ethics Committee Address
Street address City Postal code Country
El Gash street Medical Campus Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mouth opening with Digital Caliper Preoperative, after one week, three weeks and six months
Primary Outcome Pain relief VAS Preoperative, after one week, three weeks and six months
Secondary Outcome Clicking sound Preoperative, after one week, three weeks and six months
Secondary Outcome lateral excursion movements Preoperative, after one week, three weeks and six months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient clinic of the Department of Oral and Maxillofacial Surgery Faculty of Dentistry Tanta University El Gash street Medical Campus Tanta 31773 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Abd ElLatif Mosleh ElGalaa Street Quesna 32631 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Oral and Maxillofacial Surgery Department Faculty of Dentistry Tanta University El Gash street Medical Campus Tanta 31773 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Khaled Abd ElHamid Saad El Gash street Medical Campus Tanta 31773 Egypt
Abd ElFatah Abd ElMongy Sadakah El Gash street Medical Campus Tanta 31773 Egypt
Ibrahim Mohamed Nowair El Gash street Medical Campus Tanta 31773 Egypt
Ahmed Abd ElLatif Mosleh ElGalaa Street Quesna 32631 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Khaled Saad Khaled.elazab@dent.tanta.edu.eg 00201004563536 El Gash street Medical Campus
City Postal code Country Position/Affiliation
Tanta 31773 Egypt Professor of Oral And Maxillofacial Surgery Faculty of Dentistry Tanta University
Role Name Email Phone Street address
Scientific Enquiries Ahmed Mosleh Ahmed_mosleh@dent.tanta.edu.eg 00201094279620 ElGlaa Street
City Postal code Country Position/Affiliation
Quesna 32631 Egypt Lecturer of Oral And Maxillofacial Surgery Faculty of Dentistry Tanta University
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual data will be available (including data dictionaries) All of the individual participant data collected during the trial, after de-identification. Study protocol and informed consent form will be available Data will be available: - Immediately following publication with no end date. - For anyone who wishes to access the data - For any type (purpose) of analyses - Upon proposal(s) that should be directed to elsayedamr@yahoo.com Informed Consent Form,Study Protocol Immediately following publication. No end date. Proposals should be directed to elsayedamr@yahoo.com Open access will be permitted to get the data please send an e-mail to elsayedamr@yahoo.com (public relations) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information