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

Fayoum University40 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Cleft Lip

Interventions

orbicularis oris muscle Z- plasty modification of modified millard techniquePROCEDURE

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 techniquePROCEDURE

no z-plasty modification

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 6 Months

Medical Language ↔ Plain English

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

Locations (1)

Fayoum University

Al Fayyum, Egypt

Outcomes

Primary Outcomes

lip legth

evaluate the lip length of the cleft side changes from preoperative at immediate postoperative

Time frame: immediate postoperative

Secondary Outcomes

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

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: 6months

Data from ClinicalTrials.gov

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