Back to resultsEffectiveness of Rotation-advancement and Straight-line Surgical Approaches in Repairing Unilateral Cleft Lip Defect
Primary Purpose
Unilateral Cleft Lip
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Advancement-rotation approach based on Millard' for repairing lip defect.
Straight-line approach
Sponsored by
About this trial
This is an interventional treatment trial for Unilateral Cleft Lip
Eligibility Criteria
Inclusion Criteria:
- Have complete unilateral cleft lip
- from birth to 4 years old
Exclusion Criteria:
- syndromic cleft patient
Sites / Locations
- Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Advancement-rotation approach
Straight-line approach
Arm Description
Outcomes
Primary Outcome Measures
change in vertical and horizontal lip length
Measuring vertical and horizontal lip length of the constructed philtral ridge by caliper
change in lip defect
repaired lip is evaluated by direct visual inspection for the patient evaluation.
Secondary Outcome Measures
change in degree of labial scaring
Using a five-point scale based on Asher-McDade scoring system:
(very good, good, fair, poor, very poor on a scale of 1-5, where 5 represents very poor and 1 represent very good).
change in nasal symmetry
measuring total nasal width and nostril width by caliper
Full Information
NCT ID
NCT04607213
First Posted
October 16, 2020
Last Updated
October 22, 2020
Sponsor
Hams Hamed Abdelrahman
1. Study Identification
Unique Protocol Identification Number
NCT04607213
Brief Title
Effectiveness of Rotation-advancement and Straight-line Surgical Approaches in Repairing Unilateral Cleft Lip Defect
Official Title
Comparison of Rotation- Advancement and Straight-line Methods for Repairing of Unilateral Cleft Lip (Randomized Controlled Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
November 13, 2019 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
October 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hams Hamed Abdelrahman
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
compare different effects of Rotation-advancement based on the Millard technique and Straight-line based on Fisher modification as surgical approaches in repairing lip defect of unilateral cleft lip patients.
Detailed Description
Twelve participants with unilateral cleft lip equally divided into two groups. Both groups were photographed preoperative and postoperative. The Control group treated using (Rotation-advancement) based on the Millard technique; and the test group treated using (Straight-line) technique based on Fisher modification.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unilateral Cleft Lip
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Advancement-rotation approach
Arm Type
Active Comparator
Arm Title
Straight-line approach
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Advancement-rotation approach based on Millard' for repairing lip defect.
Intervention Description
patients were treated using Millard technique is the downward rotation of the medial part of the flap, and lateral advancement of the flap to close and fill the defect. if more lip height is needed; "cut- as- you-go" by adding a back-cut incision at the end of his rotation incision down toward the philtral ridge of non-clefted side. Moreover; C-flap is used to close nasal sill.
Intervention Type
Procedure
Intervention Name(s)
Straight-line approach
Intervention Description
patients were treated using Straight-Line design based on Fisher modification. C-shaped flap extend from the proposed nasal sill to the origin of philtral column of medial flap as a straight incision to the planned top of the cupid's bow. In addition, to the previous mentioned incision, small inlate incision is needed to length the cleft side on the medial flap.
On the other hand, on the lateral flap; two connected triangular incisions are used; one on the vermillion border at Noordhoff's point. And the other one just above the cutaneous margin to improve aesthetic outcome and diminish formed scar.
Primary Outcome Measure Information:
Title
change in vertical and horizontal lip length
Description
Measuring vertical and horizontal lip length of the constructed philtral ridge by caliper
Time Frame
at 3rd, 6th months
Title
change in lip defect
Description
repaired lip is evaluated by direct visual inspection for the patient evaluation.
Time Frame
at 1st, 3rd and 6th months
Secondary Outcome Measure Information:
Title
change in degree of labial scaring
Description
Using a five-point scale based on Asher-McDade scoring system:
(very good, good, fair, poor, very poor on a scale of 1-5, where 5 represents very poor and 1 represent very good).
Time Frame
at 3rd, 6th months
Title
change in nasal symmetry
Description
measuring total nasal width and nostril width by caliper
Time Frame
at 3rd, 6th months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have complete unilateral cleft lip
from birth to 4 years old
Exclusion Criteria:
syndromic cleft patient
Facility Information:
Facility Name
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
City
Alexandria
State/Province
Azarita
ZIP/Postal Code
00203
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Rotation-advancement and Straight-line Surgical Approaches in Repairing Unilateral Cleft Lip Defect
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