Back to resultsEffectiveness of Nasal-alar Elevator Combined With Taping Vs. Taping Alone on Improving the Nose Esthetics and Maxillary Arch Dimensions in Infants With Unilateral Complete Cleft Lip and Palate
Primary Purpose
Cleft Lip and Palate
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Nasal Elevator
Taping Alone
Sponsored by
About this trial
This is an interventional treatment trial for Cleft Lip and Palate
Eligibility Criteria
Inclusion Criteria:
- Infants with age range from 1-30 days.
- Unilateral complete cleft lip and alveolus.
- Medically free subjects.
- Both males and females.
- Cleft gap more than 10 mm.
Exclusion Criteria:
- Patients older than 30 days.
- Syndromic patients with other defects in addition to cleft lip and palate.
- Patients with bilateral cleft lip and palate.
- Incomplete Cleft lip.
- Patient with previous surgical lip repair or adhesion.
- Patients with previous presurgical infant orthopedic treatment.
- Medically compromised patients.
- Cleft gap distance less than 10mm
Sites / Locations
- Faculty of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Nasal Elevator
Taping Alone
Arm Description
Outcomes
Primary Outcome Measures
Nasal Esthetics
Nasal esthetics will be following Dr Farkas' measurements and it will be carried out as linear and angular measurements on standardized photographs. it will be measured using photoshop software.
Maxillary arch changes
Different maxillary arch dimensions (e.g. cleft and arch widths and symmetry) will be measured virtually on digital models in mm using 3shape software.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04331379
Brief Title
Effectiveness of Nasal-alar Elevator Combined With Taping Vs. Taping Alone on Improving the Nose Esthetics and Maxillary Arch Dimensions in Infants With Unilateral Complete Cleft Lip and Palate
Official Title
Effectiveness of Nasal-alar Elevator (NE) Combined With Taping Vs. Taping Alone on Improving the Nose Esthetics and Maxillary Arch Dimensions in Infants With Unilateral Complete Cleft Lip and Palate: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
July 9, 2020 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This randomized trial is designed to assess the effectiveness of nasal elevator as a presurgical infant orthopedics on improvement of nose esthetics vs taping alone.
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
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nasal Elevator
Arm Type
Experimental
Arm Title
Taping Alone
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Nasal Elevator
Intervention Description
A device aiming to elevate the clefted nostril extraorally and fixed on the forehead.
Intervention Type
Device
Intervention Name(s)
Taping Alone
Intervention Description
Horizontal tape alone.
Primary Outcome Measure Information:
Title
Nasal Esthetics
Description
Nasal esthetics will be following Dr Farkas' measurements and it will be carried out as linear and angular measurements on standardized photographs. it will be measured using photoshop software.
Time Frame
3 months
Title
Maxillary arch changes
Description
Different maxillary arch dimensions (e.g. cleft and arch widths and symmetry) will be measured virtually on digital models in mm using 3shape software.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
30 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Infants with age range from 1-30 days.
Unilateral complete cleft lip and alveolus.
Medically free subjects.
Both males and females.
Cleft gap more than 10 mm.
Exclusion Criteria:
Patients older than 30 days.
Syndromic patients with other defects in addition to cleft lip and palate.
Patients with bilateral cleft lip and palate.
Incomplete Cleft lip.
Patient with previous surgical lip repair or adhesion.
Patients with previous presurgical infant orthopedic treatment.
Medically compromised patients.
Cleft gap distance less than 10mm
Facility Information:
Facility Name
Faculty of Dentistry
City
Giza
ZIP/Postal Code
00202
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effectiveness of Nasal-alar Elevator Combined With Taping Vs. Taping Alone on Improving the Nose Esthetics and Maxillary Arch Dimensions in Infants With Unilateral Complete Cleft Lip and Palate
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