Two Methods of Lip Taping as a Presurgical Orthopedic Appliance
Primary Purpose
Cleft Lip and Palate
Status
Recruiting
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Lip taping
Sponsored by
About this trial
This is an interventional treatment trial for Cleft Lip and Palate
Eligibility Criteria
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.
Sites / Locations
- College of DentistryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Passive lip taping
Custom-made tape
Arm Description
Will receive passive baby feeding plate and conventional steri strip
will receive passive baby feeding plate and custom-made tape (Steri Srip and orthodontic elastics)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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')
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')
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05796336
Brief Title
Two Methods of Lip Taping as a Presurgical Orthopedic Appliance
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 12, 2023 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Baghdad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Lip and Palate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Passive lip taping
Arm Type
Experimental
Arm Description
Will receive passive baby feeding plate and conventional steri strip
Arm Title
Custom-made tape
Arm Type
Experimental
Arm Description
will receive passive baby feeding plate and custom-made tape (Steri Srip and orthodontic elastics)
Intervention Type
Device
Intervention Name(s)
Lip taping
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessment of maxillary arch dimension change
Description
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.
Time Frame
T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)]
Secondary Outcome Measure Information:
Title
Assessment of Linear measurement change
Description
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')
Time Frame
T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)]
Title
Assessment of Angular measurement change
Description
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')
Time Frame
T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)]
Title
Assessment of Parents Perception and experience
Description
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.
Time Frame
T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mushriq Abid, PhD
Phone
7718800706
Ext
00964
Email
mushriq.abid@codental.uobaghdad.edu.iq
Facility Information:
Facility Name
College of Dentistry
City
Baghdad
State/Province
Al-Rusaffa
ZIP/Postal Code
01110
Country
Iraq
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mushriq Abid, PhD
Phone
07718800706
Ext
00964
Email
mushriq.abid@codental.uobaghadad.edu.iq
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Two Methods of Lip Taping as a Presurgical Orthopedic Appliance
We'll reach out to this number within 24 hrs