Orbicularis Oris Z-plasty Modification of Modified Millard Technique and the Esthetic Outcome of Cleft Lip Repair

Cleft Lip Clinical Trial

Official title:

Esthetic Outcomes Evaluation of Unilateral Cleft Lip Repaired by Orbicularis Oris Z-plasty Modification of Modified Millard Technique Versus Modified Millard Technique. A Randomized Clinical Trail.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04627389
• Other study ID #: 27/9/20
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: June 1, 2023

Study information

• Verified date: October 2022
• Source: Fayoum University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aimed to evaluate the effect of orbicularis oris muscle z-plasty modification of modified Millard technique on the esthetic outcome and length of the repaired lip

Description:

forty patients with a unilateral cleft lip will be enrolled in this randomized comparative study. The patients will be divided into two groups, the control (group A) who treated with the modified Millard technique and the study group who repaired by orbicularis oris muscle Zplasty modification of modified Millard technique (group B).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: June 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 6 Months

Eligibility

Inclusion Criteria:

• non-syndromic cleft lip patients.
• Primary, unilateral, complete or incomplete cleft lip.
• The patient's age is younger than six months.
• lip repair performed by one craniofacial surgeon Exclusion Criteria
• syndromic cleft lip.
• Secondary lip treatment (previously operated cases)
• Bilateral cleft lip
• Patients are older than six months. Associated Cardiac anomalies. Any systemic condition

Related Conditions & MeSH terms

• Cleft Lip

Intervention

Procedure:
• orbicularis oris muscle Z- plasty modification of modified millard technique
After orbicularis oris muscle had been released from the overlying skin, the previously marked points using methylene blue for designing the z-plasty were shown to be followed by back-cut incisions including the OOM and inner mucosa in both medial and lateral elements without involving the overlying skin. This procedure resulted in two triangular flaps in both segments
• modified millard technique
no z-plasty modification

Locations

Country	Name	City	State
Egypt	Fayoum University	Fayoum

Sponsors (1)

Lead Sponsor	Collaborator
Fayoum University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lip legth	evaluate the lip length of the cleft side changes from preoperative at immediate postoperative	immediate postoperative
Secondary	Philtral ridge length symmetry index assessment	Philtral ridge symmetry index was calculated as follow:- (philtral ridge length by mm at cleft side)/(philtral ridge length by mm at non-clefted side)×100	6months
Secondary	Scar width assessment by photograph	Standard photography was taken; objective measurements were obtained from the photographs using the ruler as a control reference.; One standard surgical ruler was placed over the lower lip and a frontally orientated photograph of the patient was taken at 6m follow up to assess scar width using the Image J1.5i0R program. The first point was 1mm above the white roll and the second point was 1mm below the C-flap suture line . Scar width will be measured by two assessors and the mean score of two assessors was calculated	6months
Secondary	scar width by ultrasound	scar width will be quantified by ultrasound. The transducer placement with its upper border touching the columella-philtral junction, upper lip imaging obtained and the scar width will be measured.	6months
Secondary	scar elascitity	Scar elasticity will be quantified by ultrasound. The transducer, coupled with several millimeters of ultrasound gel, was smoothly placed in the longitudinal section and perpendicular to the skin without compressing the tissue. Compare scar stiffness in relation to adjacent normal tissue	6months