Effectiveness of Rotation-advancement and Straight-line Surgical Approaches in Repairing Unilateral Cleft Lip Defect

Not Applicable

Completed

• Conditions: Unilateral Cleft Lip
• Interventions: Procedure: Advancement-rotation approach based on Millard' for repairing lip defect.; Procedure: Straight-line approach

• Registration Number: NCT04607213
• Lead Sponsor: Hams Hamed Abdelrahman

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.

Study Timeline

• Study Start: 2019-11-13
• Status Verified: 2020-10
• Primary Completion: 2020-10-01
• Study Completion: 2020-10-01
• Study First Submitted: 2020-10-16
• Study First Submitted QC: 2020-10-22
• Last Update Submitted: 2020-10-22
• Study First Posted: 2020-10-29
• Last Update Posted: 2020-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Have complete unilateral cleft lip
• from birth to 4 years old

Exclusion Criteria

• syndromic cleft patient

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Advancement-rotation approach	Advancement-rotation approach based on Millard' for repairing lip defect.	-
Straight-line approach	Straight-line approach	-

Primary Outcome Measures

Name	Time	Method
change in vertical and horizontal lip length	at 3rd, 6th months	Measuring vertical and horizontal lip length of the constructed philtral ridge by caliper
change in lip defect	at 1st, 3rd and 6th months	repaired lip is evaluated by direct visual inspection for the patient evaluation.

Secondary Outcome Measures

Name	Time	Method
change in degree of labial scaring	at 3rd, 6th months	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	at 3rd, 6th months	measuring total nasal width and nostril width by caliper

Trial Locations

Locations (1)

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt; 🇪🇬 Alexandria, Azarita, Egypt