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

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Cleft Lip and Palate

Intervention / Treatment
-----------------
* Device: Vacuum formed aligners


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 1 Week
Maximum Age: 3 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vacuum formed aligners group<br>This group will receive Vacuum formed aligners in addition to taping for 3 Months with follow-up every 1-2 weeks | Device: Vacuum formed aligners<br>* Infants will receive this appliance which is a maxillary plate with nasal stent in addition to taping on the upper lip (taping is a modified step in Figueroa's technique.<br>|
| No Intervention: control group<br>This group will not receive any treatment | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parents' satisfaction | It will be measured by questionnaire | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Nasal morphology( Height, width, angulation of columella | It will be measured in mm by Standardized Digital photographs | 3 months | 
| Changes in Interlabial gab | It will be measured in mm by Standardized Digital photographs | 3 months | 
| Changes in Maxillary arch dimension | It will be measured in mm by Digital models | 3 months |