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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04966572
Study type Interventional
Source Cairo University
Contact Khadega Ali Al Khateeb, PhD
Phone 00201100739869
Email khadejaalkhateeb@yahoo.com
Status Recruiting
Phase N/A
Start date March 1, 2021
Completion date March 30, 2022

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