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.

Cairo University (CU)

Status: Unknown

Conditions: Bilateral Cleft Lip/Palate; Cleft Lip and Palate

Treatments: Device: Conventional Grayson acrylic formed nasoalveolar molding appliances; Device: Presurgical vacuum formed nasoalveolar molding aligners

Study type: Interventional

Funder types: Other

Identifiers

NCT04966572

BCLP_ Grayson_ vacuum

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 1 day to 1 month old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Presurgical vacuum formed nasoalveolar molding aligners group

Experimental group

Description:

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

Treatment:

Device: Presurgical vacuum formed nasoalveolar molding aligners

conventional Grayson acrylic formed nasoalveolar molding appliances group

Experimental group

Description:

This group will receive conventional Grayson acrylic formed nasoalveolar molding appliances without taping except some cases, with follow up every week for activation.

Treatment:

Device: Conventional Grayson acrylic formed nasoalveolar molding appliances