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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.
Sponsor: Tanta University
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.
Official title: Improving the Outcomes of Nasoalveolar Molding in Complete Bilateral Cleft Lip and Palate Neonates: Randomized Clinical Trial
Key Details
Gender
All
Age Range
1 Day - 15 Days
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2024-12-01
Completion Date
2026-02-01
Last Updated
2026-09-11
Healthy Volunteers
No
Interventions
vomer molding appliance
All the infants in the VMA group received clear heat cured acrylic resin appliance. Firstly, an impression was taken using additional rubber base (Zhirmach-Germany) and registering all undercuts carefully then impression was poured using Type III stone maintaining the desired undercuts around the vomer. Wax pattern of the appliance was made, with two retentive arms flasking, packing with clear heat cured acrylic resin then curing, finishing and polishing.
conventional molding appliance
After taking the impression and pouring the cast, it was prepared by blocking out all undercut areas with stone or plaster. An intraoral molding plate was then fabricated on the prepared working model using clear heat-cured acrylic resin. Retention of the appliance in both groups was achieved in the same manner; medium elastic bands (3/16 inch, 4.5 oz) were looped around each button and secured to the cheeks with surgical tape. The elastic bands were stretched to twice their passive diameter to ensure proper force activation and retention. Protective tape was applied to the cheeks to minimize tissue irritation from the surgical tapes, and further emollient creams were prescribed when needed. Additionally, horizontal lip tape was applied across the base of the nose, extending from one cheek to the other, starting from the first visit with the same-sized elastic band in the middle.
Locations (1)
Faculty of Dentistry -Tanta university
Tanta, Gharbia Governorate, Egypt