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

NCT04627389 | Unknown

• 1 other identifier: 27/9/20
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Cleft Lip

Keywords

cleft lip; chelioplasty; modified millard; orbicularis oris modification

Outcome Measures

Primary Outcomes (1)

• lip legth

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

  immediate postoperative

Secondary Outcomes (4)

• Philtral ridge length symmetry index assessment

  6months

• Scar width assessment by photograph

  6months

• scar width by ultrasound

  6months

• scar elascitity

  6months

Study Arms (2)

study arm

EXPERIMENTAL

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

controlled arm

ACTIVE COMPARATOR

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

Procedure: modified millard technique

Interventions

orbicularis oris muscle Z- plasty modification of modified millard technique PROCEDURE

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

study arm

modified millard technique PROCEDURE

no z-plasty modification

controlled arm

Eligibility Criteria

• Age: 3 Months - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• syndromic cleft lip.
• Secondary lip treatment (previously operated cases)
• Bilateral cleft lip
• Patients are older than six months. Associated Cardiac anomalies. Any systemic condition

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (1)

Fayoum University

Al Fayyum, Egypt

Location

MeSH Terms

Conditions

Cleft Lip

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• shaimaa refahee, phd

  Fayoum University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer,oral surgery

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: November 13, 2020
• Study Start: October 1, 2020
• Primary Completion: May 1, 2023
• Study Completion: June 1, 2023
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)