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

• ClinicalTrials.gov Identifier: NCT04627389
• Recruitment Status: Enrolling by invitation
• First Posted: November 13, 2020
• Last Update Posted: November 16, 2021
• Sponsor: Fayoum University
• Information provided by (Responsible Party): Shaimaa Mohsen, Fayoum University

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

Condition or disease	Intervention/treatment	Phase
Cleft Lip	Procedure: orbicularis oris muscle Z- plasty modification of modified millard technique; Procedure: modified millard technique	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: October 1, 2020
• Estimated Primary Completion Date: May 1, 2022
• Estimated Study Completion Date: June 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. lip legth [ Time Frame: immediate postoperative ]
   evaluate the lip length of the cleft side changes from preoperative at immediate postoperative

Secondary Outcome Measures :

1. Philtral ridge length symmetry index assessment [ Time Frame: 6months ]
   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
2. Scar width assessment by photograph [ Time Frame: 6months ]

   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

3. scar width by ultrasound [ Time Frame: 6months ]
   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.
4. scar elascitity [ Time Frame: 6months ]
   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

Eligibility Criteria

• Ages Eligible for Study: 3 Months to 6 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Egypt

Fayoum University

Fayoum, Egypt

Sponsors and Collaborators

Fayoum University

Investigators

• Principal Investigator: shaimaa refahee, phd; Fayoum University

More Information

• Responsible Party: Shaimaa Mohsen, lecturer,oral surgery, Fayoum University
• ClinicalTrials.gov Identifier: NCT04627389
• Other Study ID Numbers: 27/9/20
• First Posted: November 13, 2020
• Last Update Posted: November 16, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shaimaa Mohsen, Fayoum University:

cleft lip; chelioplasty; modified millard; orbicularis oris modification

Additional relevant MeSH terms:

Cleft Lip; Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities