Two Methods of Lip Taping as a Presurgical Orthopedic Appliance

April 5, 2024 updated by: Mushriq F. Abid, University of Baghdad

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 month (Child)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of maxillary arch dimension change
Time Frame: 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.
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
Time Frame: 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')
T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)]
Assessment of Angular measurement change
Time Frame: 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')
T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)]
Assessment of Parents Perception and experience
Time Frame: 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.
T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Baghdad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2023

Primary Completion (Actual)

March 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

March 18, 2023

First Submitted That Met QC Criteria

March 30, 2023

First Posted (Actual)

April 3, 2023

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 765423

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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