Back to results

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

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

NCT ID

NCT04627389

First Posted

November 4, 2020

Last Updated

October 8, 2022

Sponsor

Fayoum University

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

Time Frame

6months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Months

Maximum Age & Unit of Time

6 Months

Accepts Healthy Volunteers

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

Learn more about this trial

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

We'll reach out to this number within 24 hrs