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Completed
NCT07814625
Improving the Outcomes of Nasoalveolar Molding in Complete Bilateral Cleft Lip and Palate Neonates Using a Modification in the Design of the Conventional Molding Appliance.
Conditions: Cleft Lip and Cleft Palate, Cleft Lip Bilateral, Complete Bilateral Cleft Lip and Palate
Sex: All
Ages: 1 Day – 15 Days
Healthy volunteers: No
Phase: NA
Enrollment: 20
Sponsor: Tanta University
Location: Faculty of Dentistry -Tanta university Tanta Gharbia Governorate
Summary
The goal of this clinical trial was to improve the outcome of using the nasoalveoalr molding appliances in patients with complete bilateral cleft lip and palate.
The primary outcome was to compare VMA and CMA regarding the three-dimensional change in the maxillary arch: anteroposterior, transverse, and vertical. The changes in the maxillary arch were assessed via the digital models acquired at two time intervals: before NAM therapy and 4 months after the start of either intervention modality (VMA and CMA).
Participants were divided into two groups: the vomer molding appliance group and the conventional molding appliance group , the appliances were delivered , followed up for 4 months till primary cheiloplasty and the results were assessd before the surgert.
Eligibility Criteria
Inclusion Criteria:
* Non-syndromic complete bilateral cleft lip and palate neonate.
* The deviation of the premaxilla is to the right side for ease of comparison.
Exclusion Criteria:
* Syndromic cases.
* Patients who received former interventions.
Source: ClinicalTrials.gov (NCT07814625). StuddyBuddy aggregates publicly available trial information.