Short Term Efficiency of Presurgical Vacuum Formed Nasoalveolar Molding Aligners in Infants With Bilateral Cleft Lip and Palate Compared With Grayson Acrylic Formed Nasoalveolar Molding Appliances.

Not Applicable

• Conditions: Bilateral Cleft Lip/Palate; Cleft Lip and Palate
• Interventions: Device: Conventional Grayson acrylic formed nasoalveolar molding appliances; Device: Presurgical vacuum formed nasoalveolar molding aligners

• Registration Number: NCT04966572
• Lead Sponsor: Cairo University

Brief 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.

Detailed 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 Timeline

• Study Start: 2021-03-01
• Status Verified: 2021-07
• Study First Submitted: 2021-07-08
• Study First Submitted QC: 2021-07-08
• Last Update Submitted: 2021-07-17
• Study First Posted: 2021-07-19
• Last Update Posted: 2021-07-22
• Primary Completion: 2021-09-01
• Study Completion: 2022-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional Grayson acrylic formed nasoalveolar molding appliances group	Conventional Grayson acrylic formed nasoalveolar molding appliances	This group will receive conventional Grayson acrylic formed nasoalveolar molding appliances without taping except some cases, with follow up every week for activation.
Presurgical vacuum formed nasoalveolar molding aligners group	Presurgical vacuum formed nasoalveolar molding aligners	In this group, all patients will receive 1-2 VF-NAM aligners incorporated with palatal screw in addition to taping from day 1 for 4-6 Months with follow-up every 3 weeks

Primary Outcome Measures

Name	Time	Method
Changes in the maxillary arch	T1 and T2 (4- 6 months)	they will be measured in mm by digital models

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt