Effectiveness of Rotation-advancement and Straight-line Surgical Approaches in Repairing Unilateral Cleft Lip Defect
Comparison of Rotation- Advancement and Straight-line Methods for Repairing of Unilateral Cleft Lip (Randomized Controlled Clinical Trial)
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedFirst Submitted
Initial submission to the registry
October 16, 2020
CompletedFirst Posted
Study publicly available on registry
October 29, 2020
CompletedOctober 29, 2020
October 1, 2020
11 months
October 16, 2020
October 22, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
change in vertical and horizontal lip length
Measuring vertical and horizontal lip length of the constructed philtral ridge by caliper
at 3rd, 6th months
change in lip defect
repaired lip is evaluated by direct visual inspection for the patient evaluation.
at 1st, 3rd and 6th months
Secondary Outcomes (2)
change in degree of labial scaring
at 3rd, 6th months
change in nasal symmetry
at 3rd, 6th months
Study Arms (2)
Advancement-rotation approach
ACTIVE COMPARATORStraight-line approach
EXPERIMENTALInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- Have complete unilateral cleft lip
- from birth to 4 years old
You may not qualify if:
- syndromic cleft patient
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria, Azarita, 00203, Egypt
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant lecturer of DPH and Clinical statistician
Study Record Dates
First Submitted
October 16, 2020
First Posted
October 29, 2020
Study Start
November 13, 2019
Primary Completion
October 1, 2020
Study Completion
October 1, 2020
Last Updated
October 29, 2020
Record last verified: 2020-10