Short Term Efficiency of Presurgical Vacuum Formed Nasoalveolar Molding Aligners in Infants With Bilateral Cleft Lip and Palate Compared With Conventional Grayson Acrylic Formed Nasoalveolar Molding Appliances: A Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cleft Lip and Palate
- Sponsor
- Cairo University
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Changes in the maxillary arch
- Last Updated
- 4 years ago
Overview
Brief Summary
Newborns with bilateral cleft lip/ palate will be treated pre-surgically by either presurgical vacuum-formed nasoalveolar molding aligners VF (NAM) or conventional Grayson acrylic formed nasoalveolar molding appliances in order to evaluate their effect on the maxillary arch.
Detailed Description
The aim of this trial is to evaluate and compare the short-term effect of VF (NAM) aligners with conventional Grayson appliances at 2 stages T1 (Before NAM therapy), and T2 (After NAM therapy) as regards maxillary arch changes. Newborns with Bilateral cleft lip/ palate will be allocated randomly into two groups: the first group will receive presurgical vacuum-formed nasoalveolar molding aligners while the second group will receive conventional Grayson acrylic formed nasoalveolar molding appliances. The follow-up period will be 4-6 months till surgical lip closure. The changes in the maxillary arch will be assessed by digital maxillary models.
Investigators
Khadega Ali Al Khateeb
Phd student, faculty of Dentistry, Cairo university
Cairo University
Eligibility Criteria
Inclusion Criteria
- •Non-syndromic Infants with complete BCLP infants
- •Infants less than 1 month of age
- •Males and females.
- •Infants with displaced premaxilla
- •Patients whose parents provided written consent for the study.
Exclusion Criteria
- •Patients above 1 month of age
- •Syndromic and systemically ill infants.
- •Patients with unilateral cleft lip and palate.
- •Incomplete Cleft lip.
- •Medically compromised patients
- •Patient's/guardians who will be unwilling to go through the PNAM therapy
Outcomes
Primary Outcomes
Changes in the maxillary arch
Time Frame: T1 and T2 (4- 6 months)
they will be measured in mm by digital models