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.: PACTR202206785857005 Date of Approval: 23/06/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison between Perpendicular And Conventional Fixation In Symphyseal And Para Symphyseal Mandibular Fractures (Randomized Controlled Trial)
Official scientific title Comparison between Perpendicular And Conventional Fixation In Symphyseal And Para Symphyseal Mandibular Fractures (Randomized Controlled Trial)
Brief summary describing the background and objectives of the trial Mandibular fractures are the second most common fractures of the face after the nasal bone. Mandibular symphyseal/parasymphyseal fracture comprises 15.6 to 29.3% of mandibular fractures. The first plating system in maxillofacial surgery was introduced in 1973 by Champy and Michelet, who placed plates in the tension area of the mandible an- gle and symphysis to prevent displacement of the fracture parts of the upper border. Plates were inserted in the lower border in the premolar region which was assumed to be the compression area if the patient had teeth. Recently a perpendicular plating protocol was introduced. Application of per- pendicular plates at the lower border will allow more resistance to vertical bite forces and will constrict the motion in horizontal as well as vertical planes. This will result in better stability on the lateral surface of mandible when compared to the conventional plates. The present study was conducted to radiographically evaluate the bone density over the fracture line of the perpendicular plating protocol vs conventional Champy's protocol in mandibular symphyseal and parasymphyseal fractures on the first 24 hours , and 3 months post operatively. And to clinically evaluate the perpendicular plating protocol vs conventional Champy's protocol in mandibular symphyseal and parasymphyseal fractures.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning,Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/07/2021
Actual trial start date 01/07/2021
Anticipated date of last follow up 30/06/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants) 20
Recruitment status Closed to recruitment,follow-up continuing
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 Perpendicular fixation N/A Once Patients was treated using two 2 mm titanium mini plate placed perpendicular to each other. 10
Control Group Conventiona fixation N/A Once Patients was treated using two 2 mm titanium mini plates fixed according to the conventional. 10 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients suffering from displaced symphyseal and / or parasymphseal mandibular fractures and indicated for open reduction and internal fixation. Adult patient grees to present for follow-up visits for a minimum postoperative period of 3 months. Patients with untreated old symphyseal and / or parasymphseal mandibular fractures. Medically compromised patients contradicting operation,(uncontrolled hypertension , uncontrolled diabetes , patients under or were under radiotherapy in a period of time less than 6 months , osteoporosis patients ) Infected symphyseal and / or parasymphseal mandibular wounds Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 50 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 18/04/2021 Institutional Review Boards IRB at the faculty of dentistry Alexandria University IRB NO 00010556 IORG 0008839
Ethics Committee Address
Street address City Postal code Country
Champollion St., Azarita Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Bone density over the fracture line in mandibular symphyseal and parasymphyseal fractures first 24 hours , and 3 months post operatively
Secondary Outcome Pain first 24 hours , 1 week postoperatively
Secondary Outcome Edema first 24 hours , 1 week postoperatively
Secondary Outcome Maximum interincisal opening first 24 hours , 1 week, 3 months postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient Clinic of Alexandria University Teaching Hospital and operated in the Oral and Maxillofacial Surgery Department Faculty of Dentistry Alexandria University Champolion St., Azarita Alexandria 21521 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Nesma Anan Somaha Alexandria 21648 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Oral and Maxillofacial Surgery Department Faculty of Dentistry Alexandria University Champolion St., Azarita Alexandria 21521 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ragab Shaaban Hassan 17 Champolion St., Azarita Alexandria 21521 Egypt
Gaafar Nabil ElHalawani 17 Champolion St., Azarita Alexandria 21521 Egypt
Nesma Anan 17 Champolion St., Azarita Alexandria 21521 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ragab Shaaban Rabag_Shaaban@yahoo.com 0021001900919 17 Champollion street Al Mesallah Sharq, Al Attarin
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor of Oral and Maxillofacial Surgery Oral and Maxillofacial Surgery Department Faculty of Dentistry Alexandria University
Role Name Email Phone Street address
Scientific Enquiries Gaafar ElHalawani Gaafarelhalawani@gmail.com 0021227810403 17 Champollion street Al Mesallah Sharq, Al Attarin
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Lecturer of Oral and Maxillofacial Surgery Oral and Maxillofacial Surgery Department Faculty of Dentistry
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 Full excel sheet of data will be available upon completing the recruitment Informed Consent Form,Study Protocol 1 year 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