Cleft Lip and Palate Clinical Trial
Official title:
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
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.
Status | Recruiting |
Enrollment | 24 |
Est. completion date | March 30, 2022 |
Est. primary completion date | September 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 1 Month |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Cairo University | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in the maxillary arch | they will be measured in mm by digital models | T1 and T2 (4- 6 months) |
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