Two Methods of Lip Taping as a Presurgical Orthopedic Appliance

Study Overview
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Brief Summary
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A randomized clinical trial to compare the effectiveness of two methods of lip taping as a presurgical orthopedic appliances on maxillary arch dimensions in infants with bilateral cleft lip and palate.

Detailed Description
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It is a multicenter randomized clinical trial with two parallel arms. The patients will be randomly divided into two groups, group one: a passive orthopedic appliance will be used with conventional steri strip, and group two will receive a passive orthopedic appliance with a custom-made tape consist of steri strip and orthodontic elastic. Impressions will be taken before starting the treatment (T1) and at the end of treatment (T2) three months later. The effectiveness of the two methods of taping will be assessed and measured on digital models of the maxillary arch before and after the treatment.

Official Title
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Effectiveness of Two Methods of Lip Taping as a Presurgical Orthopedic in Infants With Bilateral Cleft Lip and Palate: A Randomized Clinical Trial

Conditions
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Cleft Lip and Palate

Intervention / Treatment
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* Device: Lip taping


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-Syndromic infants with complete bilateral cleft lip and palate. Both sexes. Age range from 1-30 day Exclusion Criteria: Infants with systemic syndromes. infants with unilateral cleft infants whom parents refuse to consent.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 1 Month

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: Passive lip taping<br>Will receive passive baby feeding plate and conventional steri strip | Device: Lip taping<br>* Steri strip tape and passive baby feeding plate Two methods of lip taping will be used with passive baby feeding plate. Impressions will be taken before starting the treatment (T1) and at the end of treatment (T2) three months later. The effectiveness of the two appliances will be assessed and measured on digital models of the maxillary arch before and after the treatment.<br>|
| Experimental: Custom-made tape<br>will receive passive baby feeding plate and custom-made tape (Steri Srip and orthodontic elastics) | Device: Lip taping<br>* Steri strip tape and passive baby feeding plate Two methods of lip taping will be used with passive baby feeding plate. Impressions will be taken before starting the treatment (T1) and at the end of treatment (T2) three months later. The effectiveness of the two appliances will be assessed and measured on digital models of the maxillary arch before and after the treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of maxillary arch dimension change | To evaluate the effect of the lip taping as a presurgical orthopedic on the maxillary arch dimensions for infants with bilateral cleft using two different types of medical taping. | T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Linear measurement change | The linear measurements of arch dimensions in millimeter before and after treatment with both methods of lip taping in both experimental groups Linear measurements for maxillary arch assessments in millimeters: Antero-posterior arch length (I-ITT') Posterior arch width (T-T') Alveolar cleft widths (AP); Right cleft and (A'P') Left cleft Mid-palatal arch width (C-C') | T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)] | 
| Assessment of Angular measurement change | The angular measurements of arch dimensions in degrees before and after treatment with both methods of lip taping in both experimental groups. Angular measurements for maxillary arch assessments in degrees: Anterior arch curvature angle (AIA') | T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)] | 
| Assessment of Parents Perception and experience | The perception and experience of parents of children with cleft lip and palate concerning the use presurgical infant orthopedics using a questionnaire-based cross-sectional survey. The assessment of mothers' perception and experience regarding PSIO will be executed using 15 validated preformed questions. | T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)] |