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

Study Overview
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Brief Summary
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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

Detailed Description
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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).

Official Title
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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.

Conditions
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Cleft Lip

Intervention / Treatment
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* Procedure: orbicularis oris muscle Z- plasty modification of modified millard technique
* Procedure: modified millard technique


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study arm<br>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<br>* 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<br>|
| Active Comparator: controlled arm<br>20 patients with a unilateral cleft lip will be repaired with modified Millard technique | Procedure: modified millard technique<br>* no z-plasty modification<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cleft lip, chelioplasty, modified millard, orbicularis oris modification