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.: PACTR202310506519010 Date of Approval: 13/10/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title naso-alveolar molding vs DynaCleft in infants with unilateral cleft lip and palate: a randomized clinical trial
Official scientific title Pre-Surgical Infant Orthopedics using Greyson Naso-alveolar molding technique versus DynaCleft with external nasal elevator in infants with unilateral cleft lip and palate: a randomized clinical trial
Brief summary describing the background and objectives of the trial Nasoalveolar molding is a procedure that is commonly used in many centers for improving cosmetic and functional aspects of the nose and maxilla before surgery in patients with unilateral cleft lip and palate. There is a striking diversity in the literature regarding treatment protocols for UCLP, with no standardized management protocols . Clinical decision-making based on evidence is lacking due to the few randomized clinical trials comparing the effectiveness of different approaches. A recent systematic review conducted a comprehensive search aiming at identifying the different treatment protocols and effectiveness of using pre-surgical infant orthopedics and recommended the need for further well-designed and high-quality randomized clinical trials in this area due to the unstandardized protocols with high diversity. Various studies supported the positive effect of naso-alveolar molding (NAM) appliance therapy on nasal symmetry in UCLP treatment. The NAM therapy decreases the severity of the initial cleft deformity and repositions deformed nasal cartilage and alveolar process, which has many beneficial results in the surgery outcome. DynaCleft with external nasal elevator is a simpler technique with no intra-oral component and could be promising. so the aim of this trial is to compare the effectiveness of NAM appliance compared to Dynacleft with nasal elevator in nasolabial soft tissue esthetics.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Unilateral Cleft Lip and Palate
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 05/09/2023
Actual trial start date
Anticipated date of last follow up 01/12/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants)
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Nam Appliance group until the infant is eligible for surgical lip repair The NAM appliance is constructed according to the Grayson technique with the nasal stent added from the start. The adhesive paste is used to hold the alveolar plate in place and labial taping is used. Patients are followed each 2 to 3 weeks for the appliance to be relined and selectively ground to modify the pressure as needed. 10
Control Group DynaCleft with external elevator until the infant is eligible for surgical lip repair DynaCleft elastic lip taping with external nasal elevator 10 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Infants with 0 (after birth) to 3 month of age - Non-syndromic with no other medical conditions - Unilateral complete cleft lip and palate - Syndromic UCLP or bilateral cleft lip and palate - Incomplete UCLP - Bilateral cleft lip and palate New born: 0 Day-1 Month 0 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
No 27/08/2023 Al Azhar Faculty of Dentistry research ethics committee
Ethics Committee Address
Street address City Postal code Country
Qesm Than Madinet Nasr, Cairo Governorate Cairo 11751 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Columella height before intervention and immediately before surgery
Secondary Outcome Nasal tip projection before intervention and immediately before surgery
Secondary Outcome Projection alar length before intervention and immediately before surgery
Primary Outcome Width of the nostril before intervention and immediately before surgery
Primary Outcome Nasal basal width before intervention and immediately before surgery
Primary Outcome Angle of the columella before intervention and immediately before surgery
Primary Outcome Cleft lip segment before intervention and immediately before surgery
Primary Outcome Height of the non-cleft lip before intervention and immediately before surgery
Primary Outcome Height of the cleft lip before intervention and immediately before surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Innovinity Medical Hub Al Arouba street - Heliopolis Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funded 38 Al Arouba street - Heliopolis Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Innovinity Medical Hub 38 AL Arouba Street - Heliopolis Cairo Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abdallah Bahaa abdallahbahaa000@gmail.com +201114084090 38 Al Arouba street - Heliopolis
City Postal code Country Position/Affiliation
Cairo Egypt Assistant Lecturer
Role Name Email Phone Street address
Public Enquiries Ahmed Ibrahim drahmed.ali.88@outlook.com +201063615001 38 Al Arouba Street - Heliopolis
City Postal code Country Position/Affiliation
Cairo Egypt Research developer
Role Name Email Phone Street address
Scientific Enquiries Ahmed Ibrahim drahmed.ali.88@outlook.com +01063615001 38 Al Arouba Street - Heliopolis
City Postal code Country Position/Affiliation
Cairo Egypt Research Developer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) wil be shared. Study Protocol After article publication Researchers who provide a methodologically sound proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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