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

Primary Purpose

Cleft Lip

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
orbicularis oris muscle Z- plasty modification of modified millard technique
modified millard technique
Sponsored by
Fayoum University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cleft Lip focused on measuring cleft lip, chelioplasty, modified millard, orbicularis oris modification

Eligibility Criteria

3 Months - 6 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fayoum University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

study arm

controlled arm

Arm Description

20 patients with a unilateral cleft lip will be repaired with orbicularis oris muscle Z-plasty modification of modified Millard technique

20 patients with a unilateral cleft lip will be repaired with modified Millard technique

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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.
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

Full Information

First Posted
November 4, 2020
Last Updated
October 8, 2022
Sponsor
Fayoum University
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1. Study Identification

Unique Protocol Identification Number
NCT04627389
Brief Title
Orbicularis Oris Z-plasty Modification of Modified Millard Technique and the Esthetic Outcome of Cleft Lip Repair
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fayoum University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Lip
Keywords
cleft lip, chelioplasty, modified millard, orbicularis oris modification

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study arm
Arm Type
Experimental
Arm Description
20 patients with a unilateral cleft lip will be repaired with orbicularis oris muscle Z-plasty modification of modified Millard technique
Arm Title
controlled arm
Arm Type
Active Comparator
Arm Description
20 patients with a unilateral cleft lip will be repaired with modified Millard technique
Intervention Type
Procedure
Intervention Name(s)
orbicularis oris muscle Z- plasty modification of modified millard technique
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
modified millard technique
Intervention Description
no z-plasty modification
Primary Outcome Measure Information:
Title
lip legth
Description
evaluate the lip length of the cleft side changes from preoperative at immediate postoperative
Time Frame
immediate postoperative
Secondary Outcome Measure Information:
Title
Philtral ridge length symmetry index assessment
Description
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
Title
Scar width assessment by photograph
Description
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
Title
scar width by ultrasound
Description
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
Title
scar elascitity
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
shaimaa refahee, phd
Organizational Affiliation
Fayoum University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fayoum University
City
Fayoum
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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

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