Two Methods of Lip Taping as a Presurgical Orthopedic Appliance

Not Applicable

Recruiting

• Conditions: Cleft Lip and Palate
• Interventions: Device: Lip taping

• Registration Number: NCT05796336
• Lead Sponsor: University of Baghdad

Brief Summary

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

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.

Study Timeline

• Study Start: 2023-01-12
• Study First Submitted: 2023-03-18
• Study First Submitted QC: 2023-03-30
• Study First Posted: 2023-04-03
• Primary Completion: 2024-03-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-05
• Last Update Posted: 2024-04-08
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Non-Syndromic infants with complete bilateral cleft lip and palate.
2. Both sexes.
3. Age range from 1-30 day

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Exclusion Criteria

1. Infants with systemic syndromes.
2. infants with unilateral cleft
3. infants whom parents refuse to consent.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Passive lip taping	Lip taping	Will receive passive baby feeding plate and conventional steri strip
Custom-made tape	Lip taping	will receive passive baby feeding plate and custom-made tape (Steri Srip and orthodontic elastics)

Primary Outcome Measures

Name	Time	Method
Assessment of maxillary arch dimension change	T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)]	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.

Secondary Outcome Measures

Name	Time	Method
Assessment of Angular measurement change	T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)]	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')
Assessment of Parents Perception and experience	T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)]	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.
Assessment of Linear measurement change	T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)]	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')

Trial Locations

Locations (1)

College of Dentistry; 🇮🇶 Baghdad, Al-Rusaffa, Iraq