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.: PACTR201607001702305 Date of Approval: 01/07/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Anchorage control using miniscrews vs Essix appliance in treatment of post-pubertal patients Class II malocclusion using Carrière Motion appliance
Official scientific title Anchorage control using miniscrews vs Essix appliance in treatment of post-pubertal patients with Class II malocclusion using Carrière Motion appliance: A single-center, randomized clinical trial
Brief summary describing the background and objectives of the trial To evaluate anchorage control using miniscrews vs Essix appliance in treatment of post-pubertal patients with Class II malocclusion using Carrière Motion appliance.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Dental Class II malocclusion,Oral Health,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/04/2014
Actual trial start date 08/04/2014
Anticipated date of last follow up 01/05/2016
Actual Last follow-up date 04/06/2016
Anticipated target sample size (number of participants) 24
Actual target sample size (number of participants) 24
Recruitment status Completed
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 Randomization was accomplished using Excel software. Simple randomization was done by writing in the first column numbers from 1 to 24 and using Kutools for Excel to randomly sort these numbers. The first 12 numbers were assigned to Group (A), while the other 12 numbers were assigned to Group (B) The randomization numbers for participants were written in opaque white papers which were folded three times to form sealed envelopes and kept inside a box. They were then kept by another member of the study Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Carrière Motion appliance and miniscrews between mandibular first molars and second premolars bilate NA Until dental Class I has been reached or 9 months A miniscrew is inserted between the mandibular first molar and second premolar bilaterally. A fixation wire is used to anchor them to the screw. A band is fitted around the second molar with an extension arm bonded on the lingual surface of the first molar. Class II elastics are then used 12
Experimental Group Carrière Motion appliance and lower Essix appliance. Until dental Class I has been reached or 9 moths A band was fitted around the mandibular second molar bilaterally. An Essix appliance was fabricated with a window opposite the second molar. Class II elastics are then used 12
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Post-pubertal patients. Class II Division 1 malocclusion with at least an end-on Class II molar relationship bilaterally. The posterior maxillary segments from the canine to maxillary second molar should be well aligned or at least on the same plane. A normal skeletal maxilla, mild to moderate retrognathic or normal mandible and normal or horizontal growth pattern. Full permanent dentition including the second maxillary and mandibular permanent molars. The patient must have good oral hygiene and should comply to instructional motivation to provide a reasonable prognosis. No previous orthodontic treatment. The patient must be medically free from any systemic disease or health problem. Systemic condition that may interfere with the treatment. Growing Patients (pre-pubertal or pubertal). Bad habits that might jeopardize the appliance. Class II division 2 malocclusion or an anterior overjet less than 2 mm. Patients with dental anomalies e.g. enamel hypoplasia, root dilacerations in maxillary canines and first molars or mandibular second molars. 14 Year(s) 30 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 12/03/2014 The Research Ethics Committee of the Faculty of Oral and Dental Medicine, Cairo University
Ethics Committee Address
Street address City Postal code Country
Saraya St, Manial Cairo 11553 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The amount of anchorage loss in the mandibular arch When dental Class I has been reached or after 9 months
Secondary Outcome The amount and type of distalization When dental Class I has been reached or after 9 months
Secondary Outcome Treatment duration When dental Class I has been reached or after 9 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient Clinic at The Department of Orthodontics, Faculty of Oral and Dental Medicine, Cairo University Saraya St. Manial Cairo 11553 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self-funded by Ahmed Fouda Saraya St. Manial Cairo 11553 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Oral and Dental Medicine, Cairo University Saraya St, Manial Cairo 11553 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Amr Abou El Ezz Saraya St. Manial Cairo 11553 Egypt
Khaled Hazem Attia Saraya St. Manial Cairo 11553 Egypt
Mai Aboul Fotouh Saraya St. Manial Cairo 11553 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Fouda ahmed.fouda@dentistry.cu.edu.eg +201226226626 Saraya St. Manial
City Postal code Country Position/Affiliation
Cairo 11553 Egypt Resident of Orthodontics, Cairo University.
Role Name Email Phone Street address
Public Enquiries Amr Abou El Ezz amrezz@yahoo.com +201222166676 Saraya St. Manial
City Postal code Country Position/Affiliation
Cairo 11553 Egypt Professor of Orthodontics and Dean of Faculty of Oral and Dental Medicine Cairo University
Role Name Email Phone Street address
Scientific Enquiries Khaled Attia khaledhattia@yahoo.com +201006694947 Saraya St. Manial
City Postal code Country Position/Affiliation
Cairo 11553 Egypt Professor of Orthodontics, Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes None Study Protocol None None
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 25/01/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 25/01/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information