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.: PACTR201803003238398 Date of Approval: 21/03/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Assessment of Two Appliances used for Infants with Complete Bilateral Cleft Lip and Palate
Official scientific title Assessment of Two Appliances Fabricated by Cad Cam Used for Infants with Complete Bilateral Cleft Lip and Palate (A Comparative Clinical Trial)
Brief summary describing the background and objectives of the trial Cleft lip and palate (CLP) affects about 1.5 per 1000 live births (250,000 new cases per year) worldwide. They can be either unilateral or bilateral, complete or incomplete. The bilateral cleft lip and palate (BCLP) deformity typically arises with a protrusive premaxilla. The lip segments are widely separated and the columella is shortened. Nasoalveolar moulding (NAM) technique, aims to properly align the alveolus, lip, and nose; reduce the severity of the nasal deformity; and lengthen the columella without surgery. Opponents to NAM therapy state that it requires much dedication and extensive taping. On the other hand, another appliance consists of two separate parts, one on the premaxilla and the other on the maxillary segments. It achieves retraction of the premaxilla through orthodontic elastics on hooks which will also lengthen the columella and improve the nasal measurements. The aim of the study is to assess the NAM appliance and the two-piece premaxillary retractor, fabricated by CAD/CAM additive manufacturing, by using virtual planning in complete BCLP.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Complete Bilateral Cleft Lip and Palate,Musculoskeletal Diseases,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/04/2018
Actual trial start date 01/04/2018
Anticipated date of last follow up 31/03/2019
Actual Last follow-up date 31/03/2019
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants) 20
Recruitment status Not yet recruiting
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 Permuted block randomi sation (variable block size) Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group NAM appliance 3 months The Nasoalveolar molding appliance will be constructed using CAD CAM and virtual planning and will be inserted using tapes and orthodontic elastics. Nasal stents will then be attached. 10
Experimental Group two¿piece premaxillary retractor 3 months The two piece appliance will be constructed using CAD CAM and virtual planning. Retraction will be achieved by orthodontic elastics attached to hooks on the two pieces of the appliance. 10
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients should present with complete bilateral cleft lip and palate. Patient age should not be more than 3 months. Patients with congenital malformations and systemic syndromes. 5 Day(s) 3 Month(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 01/01/2018 IRB: Faculty of Dentistry, Alexandria University
Ethics Committee Address
Street address City Postal code Country
Champollion Street, Azarita Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Retraction of the premaxilla and reduction of the cleft gaps according to the required endpoint of treatment obtained in the virtual plan. Assessment of maxillary geometry before treatment and after 3 months.
Primary Outcome Improvement of nasal measurements. Nasal measurements before treatment and after 3 months.
Secondary Outcome Comparison of maxillary geometry with the planned endpoint of treatment obtained in the virtual plan. After 3 months.
Secondary Outcome Comparison of the effect of the two appliances (NAM and two-piece premaxillary retractor) regarding maxillary geometry and nasal measurements. After 3 months.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Maxillofacial Department, Faculty of Dentistry, Alexandria University. Champollion St., Azarita Alexandria 21521 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Maxillofacial Department, Faculty of Dentistry, Alexandria University. Champollion St., Azarita Alexandria 21521 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Dentistry, Alexandria University. Champollion St., Azarita Alexandria 21521 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmad Al-Shimy Champollion St., Azarita Alexandria 21521 Egypt
Ahmed Serag El-Din Habib Champollion St., Azarita Alexandria 21521 Egypt
Ibrahim M. El Fahham Lotfy elsied St. off Gamal Abdelnasser Alexandria 21532 Egypt
Mona Sabry Mostafa Saad Champollion St., Azarita Alexandria 21521 Egypt
Kenda Ibrahim Hisham Hanno Champollion St., Azarita Alexandria 21521 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmad Al-Shimy ahmadalshimy@yahoo.com 00201227431353 Champollion St., Azarita
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor and head of Prosthodontics Department, Faculty of Dentistry, University of Alexandria
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
Role Name Email Phone Street address
Scientific Enquiries Mona Saad mon_sabry2@yahoo.com 00201005126021 Champollion St., Azarita
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Lecturer of Prosthodontics Faculty of Dentistry, University of Alexandria
REPORTING
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