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)

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.

Study Overview

• Status: Completed
• Conditions: Unilateral Cleft Lip
• Intervention / Treatment: Procedure: Advancement-rotation approach based on Millard' for repairing lip defect.; Procedure: Straight-line approach

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Azarita
    • Alexandria, Azarita, Egypt, 00203
      • Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• syndromic cleft patient

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Advancement-rotation approach	Procedure: Advancement-rotation approach based on Millard' for repairing lip defect.; 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.
Experimental: Straight-line approach	Procedure: Straight-line approach; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	at 3rd, 6th months
change in nasal symmetry	measuring total nasal width and nostril width by caliper	at 3rd, 6th months

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2019
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: October 16, 2020
• First Submitted That Met QC Criteria: October 22, 2020
• First Posted (Actual): October 29, 2020

Study Record Updates

• Last Update Posted (Actual): October 29, 2020
• Last Update Submitted That Met QC Criteria: October 22, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Mouth Diseases; Lip Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Cleft Lip
• Other Study ID Numbers: Cleft lip_00010556

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No