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

Not Applicable

• Conditions: Cleft Lip and Palate
• Interventions: Device: Vacuum formed aligners

• Registration Number: NCT03011489
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-01-04
• Study First Submitted QC: 2017-01-04
• Study First Posted: 2017-01-05
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-22
• Last Update Posted: 2017-04-25
• Primary Completion: 2017-06
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 14

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Parents' satisfaction	3 months	It will be measured by questionnaire

Secondary Outcome Measures

Name	Time	Method
Changes in Nasal morphology( Height, width, angulation of columella	3 months	It will be measured in mm by Standardized Digital photographs
Changes in Interlabial gab	3 months	It will be measured in mm by Standardized Digital photographs
Changes in Maxillary arch dimension	3 months	It will be measured in mm by Digital models