Effect of Using Two Different Construction Techniques of Nasoalveolar Molding Devices in Unilateral Cleft Lip and Palate Patients

Launched by MINIA UNIVERSITY · Apr 20, 2023

Keywords

ClinConnect Summary

This study is a randomized trial that compares two ways of making nasoalveolar molding (NAM) devices, which are used in babies with unilateral cleft lip and palate to shape the upper jaw and nose before surgery. The goal is to see how these two construction methods affect changes in the upper jaw, especially the width of the alveolar cleft, after about 3 months, using three‑dimensional measurements. It’s a treatment study, and the assignment to the two methods is by chance.

Eligible participants are healthy newborns with non-syndromic unilateral cleft lip and palate, of any gender, aged roughly 7 days to under 1 month at enrollment. Parents must be willing to participate and sign informed consent. Exclusions include babies with other systemic diseases or syndromes. Babies will be randomly assigned to receive either conventionally constructed NAM devices or digitally constructed NAM devices, in a parallel design, and neither the families nor the people assessing the outcomes will know which method was used. They will wear or use the NAM device and be followed for about 3 months to measure the alveolar cleft width. The study is being conducted at Minia University in Egypt, and results are not available yet.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Good general health without any systematic disease, disability or other syndromes Non syndromatic unilateral cleft lip and palate Both genders Age less than one month Parents willing to participate in the study and sign informed consent
• Exclusion Criteria:
• • Patients exhibiting systemic disease, disability or other syndrome, parents denying participating in the study or not given their informed consent