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 |
|
|