Two Methods of Lip Taping as a Presurgical Orthopedic Appliance

Cleft Lip and Palate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05796336
• Other study ID #: 765423
• Status: Recruiting
• Phase: N/A
• Start date: January 12, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: April 2024
• Source: University of Baghdad
• Contact: Mushriq Abid, PhD
• Phone: 7718800706
• Email: mushriq.abid[@]codental.uobaghdad.edu.iq
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: May 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 1 Month

Eligibility

Inclusion Criteria:

1. Non-Syndromic infants with complete bilateral cleft lip and palate.

2. Both sexes.

3. Age range from 1-30 day

Exclusion Criteria:

1. Infants with systemic syndromes.

2. infants with unilateral cleft

3. infants whom parents refuse to consent.

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Lip and Palate

Intervention

Device:
• Lip taping
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.

Locations

Country	Name	City	State
Iraq	College of Dentistry	Baghdad	Al-Rusaffa

Sponsors (1)

Lead Sponsor	Collaborator
University of Baghdad

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)]
Secondary	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)]
Secondary	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)]