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

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.

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Cleft Lip
• Intervention / Treatment: Procedure: orbicularis oris muscle Z- plasty modification of modified millard technique; Procedure: modified millard technique

Detailed 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).

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Fayoum, Egypt
    • Fayoum university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 10 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study arm; 20 patients with a unilateral cleft lip will be repaired with orbicularis oris muscle Z-plasty modification of modified Millard technique	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
Active Comparator: controlled arm; 20 patients with a unilateral cleft lip will be repaired with modified Millard technique	Procedure: modified millard technique; no z-plasty modification

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
lip legth	evaluate the lip length of the cleft side changes from preoperative at immediate postoperative	immediate postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Fayoum University
• Investigators: Principal Investigator: shaimaa refahee, phd, Fayoum university

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: November 4, 2020
• First Submitted That Met QC Criteria: November 7, 2020
• First Posted (Actual): November 13, 2020

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 8, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: cleft lip; chelioplasty; modified millard; orbicularis oris modification
• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Mouth Diseases; Lip Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Cleft Lip
• Other Study ID Numbers: 27/9/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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