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.: PACTR202408851121914 Date of Approval: 02/08/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Use of Arch Bars versus IMF-Screws in Maxillomandibular Fixation of Mandibular Fractures: A Randomized Prospective Study with Special Evaluation of Sonographic Findings and Quality of Life
Official scientific title Use of Arch Bars versus IMF-Screws in Maxillomandibular Fixation of Mandibular Fractures: A Randomized Prospective Study with Special Evaluation of Sonographic Findings and Quality of Life
Brief summary describing the background and objectives of the trial Traditionally, arch bars are used for mandibulomaxillary fixation (MMF) of mandibular fractures. The introduction of intermaxillary fixation screws (IMFS) has provided an alternative for this purpose. We compared the arch bar versus IMFS for treatment of mandibular fractures including evaluation of sonographic findings and Quality of Life (QoL).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/10/2021
Actual trial start date 01/10/2021
Anticipated date of last follow up 01/10/2022
Actual Last follow-up date 01/10/2022
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Completed
Publication URL Nil
Secondary Ids Issuing authority/Trial register
617 University of Maiduguri Teaching Hospital Ethical Review Committee
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table from a statistics book Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Arch bar 6 weeks closed reduction and immobilization using arch bar 25 Active-Treatment of Control Group
Experimental Group intermaxillary fixation screw 6 weeks Close reduction and immobilization using intermaxillary fixation screw 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
mandibular fracture that is simple unilateral undisplaced or minimally displaced fracture in either symphysis, parasymphysis, or body of the mandible. Any fracture involving the angle, ramus and condyle multiple, comminuted or pathologic fractures patients with associated head injury or systemic debilitating diseases, smokers Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 10/05/2021 UMTH Research Ethical Committee
Ethics Committee Address
Street address City Postal code Country
Bama road Maiduguri Maiduguri 600230 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Degree of Mouth opening 6 week
Primary Outcome Occlusion 6 week
Primary Outcome Pain daily for first 3 days
Primary Outcome Fracture healing week 3 and week 6
Secondary Outcome Operating time time taken for fixation in minutes
Secondary Outcome Oral hygiene at 6 week
Secondary Outcome wire prick injury during fixation
Secondary Outcome Screw fracture during insertion
Secondary Outcome Parasthesia during fixation
Secondary Outcome Infection 6 week period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of maiduguri Teaching Hospital Bama road Maiduguri Maiduguri 600230 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Nil Nil Nil Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Nil Nil Nil Nigeria Nil
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mukhtar Modibbo Ahmad dentmamodibbo@gmail.com +2348065595483 Bama road Maiduguri
City Postal code Country Position/Affiliation
Maiduguri 600242 Nigeria Hospital consultant
Role Name Email Phone Street address
Public Enquiries Mukhtar Modibbo Ahmad dentmamodibbo@gmail.com +2348065596483 Bama road
City Postal code Country Position/Affiliation
Maiduguri 600242 Nigeria Hospital consultant
Role Name Email Phone Street address
Scientific Enquiries Mukhtar Modibbo Ahmad dentmamodibbo@gmail.com +2348065596483 Bama road
City Postal code Country Position/Affiliation
Maiduguri 600242 Nigeria Hospital consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Yes, All of the individual participant data collected during the trial, after deidentification Statistical Analysis Plan,Study Protocol Beginning three months and ends 5 years after publications Researchers who provides methodologically sound proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 04/07/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 04/07/2024 Result - 04/07/2024 Result - 04/07/2024 Result - 04/07/2024 Result - 04/07/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information