Two Methods of Lip Taping as a Presurgical Orthopedic Appliance

• Sponsor: University of Baghdad (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05796336
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 6.6
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cleft Lip and Palate	Device: Lip taping	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jan 12, 2023
• Anticipated Primary Completion Date: Jul 1, 2023
• Anticipated Study Completion Date: Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Passive lip taping Will receive passive baby feeding plate and conventional steri strip	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.
Experimental: Custom-made tape will receive passive baby feeding plate and custom-made tape (Steri Srip and orthodontic elastics)	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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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')

2. 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')

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Day to 1 Month
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	College of Dentistry	Baghdad	Al-Rusaffa	Iraq	01110

Sponsors and Collaborators

• University of Baghdad

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mushriq F. Abid, Professor, University of Baghdad
• ClinicalTrials.gov Identifier: NCT05796336
• Other Study ID Numbers: 765423
• First Posted: Apr 3, 2023
• Last Update Posted: Apr 3, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cleft Lip

Study Results

No Results Posted as of Apr 3, 2023