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.: PACTR201308000492164 Date of Approval: 01/02/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Three dimensional miniplates versus standard miniplates in fixation of angle mandibular fracture -randomized controlled clinical trial
Official scientific title Three dimensional miniplates versus standard miniplates in fixation of angle mandibular fracture - a randomized controlled clinical trial
Brief summary describing the background and objectives of the trial INTRODUCTION: The mandibular angle is one of the most frequent sites of fractures of the lower jaw accounting for around 20-30% of all fractures occurring in the mandible. (1,2).The use of a single miniplate for fixation of angle fractures of the mandible has been debated over the years. The conventional rigid fixation technique employs thick compression plate along the lower border of the mandible which negated the forces of torsion and shear, but had the disadvantage of bicortical screws, whereas, the Champy¿s osteosynthesis principle produced a natural strain of compression along the lower border of the mandible caused due to mastication. These drawbacks of rigid and semi rigid fixation led to the development of three-dimensional (3D) miniplate consisting of two miniplates joined by interconnecting struts. 3 These plates are highly malleable, offer good resistance against torque forces and most importantly low profile, and their stability doesn't derive from the thickness of the plate (3) OBJECTIVES: The objective of this review was to provide reliable evidence regarding the effectiveness of three dimensional miniplate versus conventional for fixation of angle mandibular fractures.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied angle mandibular fracture,Musculoskeletal Diseases,Oral Health,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 06/01/2013
Actual trial start date 16/05/2012
Anticipated date of last follow up 10/01/2013
Actual Last follow-up date 10/01/2013
Anticipated target sample size (number of participants) 10
Actual target sample size (number of participants) 10
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
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 a computer software program Sealed opaque envelopes Open-label(Masking Not Used) Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group single miniplate by champy techenque 6 months internal rigid fixation by open reduction 5
Experimental Group three dimensional miniplate 6 month open reduction with internal rigid fixation 5
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-Randomized or quasi randomized controlled trials (RCTs) and controlled clinical trial (CCTs) comparing three dimensional and standard (Champy¿s technique) in fixation of the mandibular angle fracture. 2-Adults dentate patients (>17 years old) with an angle mandibular fracture undergoing open reduction with internal rigid fixation. 3-Any studies comparing the three dimensional miniplate and standard miniplate (Champy technique) in the fixation of angle mandibular fracture . All other types of study design, such as case series, case reports, technical reports, animal studies and reviews were excluded 17 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 01/02/2013 Ethic research committee
Ethics Committee Address
Street address City Postal code Country
11 saraya cairo
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome potoperative complication (infection+malocclusion) infection measured by clinical examination after 3 month malocclusion evualuated by surgons and patients
Secondary Outcome potoperative bone healing (bone density) bone density evaluated radiographically by panoramic film using digora software system
Secondary Outcome hardware failure+mal and un uinon clincally and radiographically
Secondary Outcome trismus in millimter by using boely gauge after 3 month
Secondary Outcome time of operation in minutes
Secondary Outcome potoperative parasthesia clinical evaulation of parestheisa only after 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of oral and dental medicine 11 sarya st Cairo
FUNDING SOURCES
Name of source Street address City Postal code Country
faculty of dentistry radaa st dhamar 00967 Yemen
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of dentistry radaa st dhamar Yemen University
COLLABORATORS
Name Street address City Postal code Country
tarek elghareeb 11 sarya st cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator tarek elshrqawey tarek_elshrqawy@hotmail.com 01222255907 11 saray st
City Postal code Country Position/Affiliation
cairo main supervisor
Role Name Email Phone Street address
Principal Investigator Essam almoraissi dr_essamalmoraissi@yahoo.com 0021141477753 faysal
City Postal code Country Position/Affiliation
cairo Egypt lecturer in faculty of dentistry Thamar univeristy
Role Name Email Phone Street address
Public Enquiries ESSAM colleague dressamalmoraissi@gmail.com 967777788939
City Postal code Country Position/Affiliation
sanaa Yemen lecturer in faculty of dentistry
Role Name Email Phone Street address
Scientific Enquiries tarek elghareeb t_elghareeb@hotmail.com 00201227418235 saraya st
City Postal code Country Position/Affiliation
cairo Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries tarek elshrqawey tarek_elshrqawy@hotmail.com 01222255907 11 saray st
City Postal code Country Position/Affiliation
cairo main supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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