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

F

Fayoum University

Status

Invitation-only

Conditions

Cleft Lip

Treatments

Procedure: orbicularis oris muscle Z- plasty modification of modified millard technique
Procedure: modified millard technique

Study type

Interventional

Funder types

Other

Identifiers

NCT04627389
27/9/20

Details and patient eligibility

About

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

Full 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).

Enrollment

40 estimated patients

Sex

All

Ages

3 to 6 months old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

study arm
Experimental group
Description:
20 patients with a unilateral cleft lip will be repaired with orbicularis oris muscle Z-plasty modification of modified Millard technique
Treatment:
Procedure: orbicularis oris muscle Z- plasty modification of modified millard technique
controlled arm
Active Comparator group
Description:
20 patients with a unilateral cleft lip will be repaired with modified Millard technique
Treatment:
Procedure: modified millard technique

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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