Parent's Satisfaction and Evaluation of Postsurgical Outcomes in Unilateral Cleft Lip / Palate Newly Born Infants With / Without Vacuum Formed Nasoalveolar Molding Aligners : A Controlled Clinical Trial

Cairo University (CU)

Status: Unknown

Conditions: Cleft Lip and Palate

Treatments: Device: Vacuum formed aligners

Study type: Interventional

Funder types: Other

Identifiers

NCT03011489

UCLP_Vacuum

Details and patient eligibility

About

Newborns with unilateral cleft lip/ palate will be treated pre-surgically by Vacuum formed aligners in order to evaluate its effect on Nasoalveolar complex.

Full description

newborns with unilateral cleft lip/ palate will be allocated into two groups: treatment group will receive Vacuum formed aligners while control group will not receive Vacuum formed aligners.

the follow-up period will be 3 months till surgical lip closure. the assessment will be through a questionnaire for the parents' satisfaction outcome, standardized photographs for measurement of nasal changes and interlabial gap outcome and digital maxillary models for the maxillary dimension change outcome.

Enrollment: 14 estimated patients

Sex: All

Ages: 1 week to 3 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Non-syndromic Infants with complete unilateral cleft lip and palate
• Infants less than 3 months of age
• Males and females.
• Infants with displaced alveolus
• Patients whose parents provided written consent for the study.

Exclusion criteria

• Patients above 3 months of age
• Syndromic, malnourished and systemically ill infants.
• Patients with bilateral 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: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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14 participants in 2 patient groups

Vacuum formed aligners group

Experimental group

Description:

This group will receive Vacuum formed aligners in addition to taping for 3 Months with follow-up every 1-2 weeks

Treatment:

Device: Vacuum formed aligners

control group

No Intervention group

Description:

This group will not receive any treatment