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

NCT ID: NCT04627389

Last Updated: 2022-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2023-06-01

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).

Conditions

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Cleft Lip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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study arm

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

Group Type EXPERIMENTAL

orbicularis oris muscle Z- plasty modification of modified millard technique

Intervention Type 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

controlled arm

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

Group Type ACTIVE_COMPARATOR

modified millard technique

Intervention Type PROCEDURE

no z-plasty modification

Interventions

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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

Intervention Type PROCEDURE

modified millard technique

no z-plasty modification

Intervention Type PROCEDURE

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
Minimum Eligible Age

3 Months

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fayoum University

OTHER

Sponsor Role lead

Responsible Party

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Shaimaa Mohsen

lecturer,oral surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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shaimaa refahee, phd

Role: PRINCIPAL_INVESTIGATOR

Fayoum University

Locations

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Fayoum University

Al Fayyum, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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27/9/20

Identifier Type: -

Identifier Source: org_study_id

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