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

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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04627389
Enrollment
40
Registered
2020-11-13
Start date
2020-10-01
Completion date
2023-06-01
Last updated
2022-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cleft Lip

Keywords

cleft lip, chelioplasty, modified millard, orbicularis oris modification

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).

Interventions

PROCEDUREorbicularis 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

PROCEDUREmodified millard technique

no z-plasty modification

Sponsors

Fayoum University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Months to 6 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
lip legthimmediate postoperativeevaluate the lip length of the cleft side changes from preoperative at immediate postoperative

Secondary

MeasureTime frameDescription
Philtral ridge length symmetry index assessment6monthsPhiltral 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 photograph6monthsStandard 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 ultrasound6monthsscar 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 elascitity6monthsScar 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026