Back to resultsEvaluation of the Clinical Effectiveness of Naso-alveolar Molding (NAM) Versus Computer Aided Design NAM (CAD/NAM) in Infants With Bilateral Cleft Lip and Palate: A Randomized Clinical Trial
Primary Purpose
Cleft Lip and Palate
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Naso-alveolar molding (NAM)
Computer aided design NAM (CAD/NAM)
Sponsored by
About this trial
This is an interventional treatment trial for Cleft Lip and Palate
Eligibility Criteria
Inclusion Criteria:
• Bilateral cleft lip and palate
Exclusion Criteria:
Patients without cleft palate Unilateral cleft lip Patients having systemic medical problems that contraindicate NAM treatment Patients with history of previous presurgical infant orthopedics Patients with history of any surgical procedures (ex: lip adhesion)
Sites / Locations
- Faculty of Oral and Dental Medicine, Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Naso-alveolar molding (NAM)
Computer aided design NAM (CAD/NAM)
Arm Description
Active plates and nasal stents (Grayson method)
Computer aided design active plates and nasal stents
Outcomes
Primary Outcome Measures
Alveolar alignment
Reference points,lines and planes on digital models recording the symmetry and alignment of maxillary arch segments
Secondary Outcome Measures
Nasal and labial esthetics
Reference points, lines and planes on standardized photos recording the collumellar length, symmetry of nostrils and interlabial gap
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02881606
Brief Title
Evaluation of the Clinical Effectiveness of Naso-alveolar Molding (NAM) Versus Computer Aided Design NAM (CAD/NAM) in Infants With Bilateral Cleft Lip and Palate: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
May 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Bilateral cleft lip and palate neonates will be randomly assigned to one of two groups: (gp1 presurgical Naso-alveolar molding (NAM) using Grayson method, gp 2 computer aided design NAM (CAD/NAM). The aim of the study is to compare between short term clinical effects of both interventions as regards alveolar alignment, nasal esthetics and interlabial gap.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Lip and Palate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Masking Description
Blinding was done for the plastic surgeon (care provider) during lip repair and for the outcome assessor
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Naso-alveolar molding (NAM)
Arm Type
Active Comparator
Arm Description
Active plates and nasal stents (Grayson method)
Arm Title
Computer aided design NAM (CAD/NAM)
Arm Type
Active Comparator
Arm Description
Computer aided design active plates and nasal stents
Intervention Type
Device
Intervention Name(s)
Naso-alveolar molding (NAM)
Intervention Type
Device
Intervention Name(s)
Computer aided design NAM (CAD/NAM)
Primary Outcome Measure Information:
Title
Alveolar alignment
Description
Reference points,lines and planes on digital models recording the symmetry and alignment of maxillary arch segments
Time Frame
5-6 months
Secondary Outcome Measure Information:
Title
Nasal and labial esthetics
Description
Reference points, lines and planes on standardized photos recording the collumellar length, symmetry of nostrils and interlabial gap
Time Frame
5-6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Days
Maximum Age & Unit of Time
60 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• Bilateral cleft lip and palate
Exclusion Criteria:
Patients without cleft palate Unilateral cleft lip Patients having systemic medical problems that contraindicate NAM treatment Patients with history of previous presurgical infant orthopedics Patients with history of any surgical procedures (ex: lip adhesion)
Facility Information:
Facility Name
Faculty of Oral and Dental Medicine, Cairo University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Evaluation of the Clinical Effectiveness of Naso-alveolar Molding (NAM) Versus Computer Aided Design NAM (CAD/NAM) in Infants With Bilateral Cleft Lip and Palate: A Randomized Clinical Trial
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