Effect of Novel Nasoalveolar Molding Techniques on Parents' Satisfaction and Short Term Treatment Outcomes in Unilateral Cleft Lip and Palate Infants: A Randomized Controlled Trial

Study Overview
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Brief Summary
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The aim of this trial is to figure out the efficiency of modified Grayson NAM on parents' satisfaction, nasal esthetics, interlabial gap and maxillary arch changes. NAM might improve and facilitate the surgical procedure after lip closure. This might decrease the need of further interventions to improve esthetics and function of CLP patients. This trial will help the patients and practitioners in taking the decision of inclusion of NAM in the CLP treatment protocol as a mandatory step or skip a useless procedure with all of its burden.

Detailed Description
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In this randomized trial, 4 groups will be included. The first group will receive a modified nasoalveolar molding appliance in addition to taping. In the second group, the patient will receive the CAD/NAM. the third group is tape only, while the fourth group remain untreated. the follow-up period will be 3 months till surgical lip closure. the assessment will be through a questionnaire for the parents' satisfaction outcome, photographs for nasal esthetics and interlabial gap outcome and maxillary models for the maxillary dimension change outcome.

Official Title
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Effect of A Novel (Modified Grayson) Technique for Nasoalveolar Molding and Taping on Parents' Satisfaction and Short Term Treatment Outcomes in Infants With Unilateral Complete Cleft Lip and Palate: A Randomized Controlled Trial

Conditions
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Cleft Lip and Palate

Intervention / Treatment
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* Device: Modified Nasoalveolar molding
* Device: Taping
* Device: CAD/NAM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants with age range from 7 - 30 days. Unilateral complete cleft lip and alveolus. Presence of unilateral cleft palate. Medically free subjects. Both males and females. Exclusion Criteria: Patients older than 30 days. Syndromic patients with other defects in addition to cleft lip and palate. Patients with bilateral cleft lip and palate. Incomplete Cleft lip. Medically compromised patients.

Ages Eligible for Study
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Minimum Age: 7 Days
Maximum Age: 30 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified Nasoalveolar molding group<br>This group will receive nasoalveolar molding appliance in addition to taping for 3 Months with follow-up every 2 weeks. | Device: Modified Nasoalveolar molding<br>* Infants will receive this appliance which is a maxillary plate with nasal stent in addition to taping on the upper lip (taping is routine step in Grayson's nasoalveolar molding technique).<br>|
| Experimental: Taping group<br>Tape will be used alone in this group on the upper lip segments for 3 months with follow-up every 2 weeks. | Device: Taping<br>* Infants will receive a tape only on the upper lip segments to mold it to touch each other.<br>|
| No Intervention: Control group<br>This group will not receive any treatment. | |
| Experimental: CAD/NAM group<br>Computer Aided Designed Nasoalveolar molding and 3D printed. | Device: CAD/NAM<br>* computer aided design NAM<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parents' satisfaction | It will be assessed using Questionnaire. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal Esthetics: a- Nostril height | It will be measured in mm by Digital ruler on the images using a software. | 3 months | 
| Nasal Esthetics: b- Nostril width | It will be measured in mm by Digital ruler on the images using a software. | 3 months | 
| Nasal Esthetics: c- Nasal sill height | It will be measured in mm by Digital ruler on the images using a software. | 3 months | 
| Nasal Esthetics: d- Nostril area | It will be measured on the images in mm 2 (square) using a software measuring area. | 3 months | 
| Interlabial gap | It will be measured in mm by Digital ruler on the images using a software. | 3 months | 
| Maxillary Arch Dimension | It will be measured as distances in mm between landmarks identified on the dental models assessing the anterioposterior, transverse and vertical changes. | 3 months |