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

Unilateral Cleft Lip Clinical Trial

Official title:

Comparison of Rotation- Advancement and Straight-line Methods for Repairing of Unilateral Cleft Lip (Randomized Controlled Clinical Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04607213
• Other study ID #: Cleft lip_00010556
• Status: Completed
• Phase: N/A
• Start date: November 13, 2019
• Est. completion date: October 1, 2020

Study information

• Verified date: October 2020
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 4 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• syndromic cleft patient

Related Conditions & MeSH terms

• Cleft Lip
• Unilateral Cleft Lip

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt	Alexandria	Azarita

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in vertical and horizontal lip length	Measuring vertical and horizontal lip length of the constructed philtral ridge by caliper	at 3rd, 6th months
Primary	change in lip defect	repaired lip is evaluated by direct visual inspection for the patient evaluation.	at 1st, 3rd and 6th months
Secondary	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
Secondary	change in nasal symmetry	measuring total nasal width and nostril width by caliper	at 3rd, 6th months