Unilateral Cleft Lip Repair : Modified Millard and Mishra Technique

Comparative Study Between Modified Millard and Mishra Technique in Unilateral Cleft Lip Repair: a Randomised Controlled Study

Our study findings show that vertical lip length and philtral lip height significantly longer in Millard group than Mishra group in immediate postoperative assessment and nasal width was significantly wider in Mishra group than Millard in 3-month postoperative assessment, This may be attributed to that Mishra group deformity was more severe. The lip shape, the vermilion shape was better in Millard technique than Mishra technique, however, this was statistically insignificant The scar shape was less evident in Mishra technique than Millard technique. But this was also statistically insignificant. However, no major difference in the overall results between the Mishra and Millard rotationadvancement repairs. Thus, either technique could be used for unilateral clefts, as the goal of cleft lip repair is making a symmetrical lip with minimal scar restoring the normal appearance of the face and functional anatomy Anthropometric Measurement of surgical outcome evaluates the surgical technique used and helps to compare between cleft and non-cleft side showing the degree of deformity and we used Subjective assessment to analyse facial aesthetics and appearance impairment as the harmony of a person's face is as Important as measurements, so they should be used together in our opinion.

Study Overview

• Status: Completed
• Conditions: Cleft Lip
• Intervention / Treatment: Procedure: Unilateral cleft lip repair

Detailed Description

Cleft lip and palate, which affects 0.5-1.6 out of every 1000 live births, is the most prevalent congenital defect of the head and neck .

When the palatal shelves and the medial nasal process fail to fuse together between the fourth and eighth weeks of development, unilateral cleft lip and palate results . Lip muscles are disrupted and abnormally inserted to the columellar base on the non-cleft side and from the alar base on the cleft side. The nasal floor and alveolus on the cleft side may be deficient or absent. Several approaches, including quadrangular flaps, triangular flaps, and rotationadvancement procedures, were established in the middle of the twentieth century White Roll Vermilion Turn Down Flap (WRV flap) from the lateral lip element Making a symmetrical lip with a small scar and restoring the face's natural appearance and functional structure are the objectives of cleft lip repair . Over the past century, numerous surgical repair approaches have been developed The first known cleft-lip repair was a straight-line suture and a simple cut along the cleft borders, followed by a curved incision to lengthen the lip Drawbacks of straight-line restorations included vertical scar contracture and lip notching Tennison-triangular Randall's approach, which relies on mathematical calculations and lessens vertical lip contraction, is the most popular triangular technique, however the scar violates the philtrum.The Millard rotation-advancement approach was created to align the scar with the philtral column naturally occurring. The initial rotation-advancement technique underwent various variations. Vermilion notching and a scar along the philtral line can be noticed in Millard's repair. The Cupid's bow is distorted and the white roll up is pulled up by scar contracture. was employed by Mishra to modify Millard's technique to create the vermilion and white roll on the medial lip segment. If there is medial hypoplastic vermilion or partial medial vermilion loss, the Mishra procedure is also used Anthropometric Evaluation of surgical technique and comparison of cleft and non-cleft sides are two benefits of measuring surgical outcome .Farkas and colleagues, provided normative measurements of the lip and nose. Qualitative Assessment is subjective assessment and can analyze facial aesthetics and appearance impairment using scales, indices, scoring systems, and rankings. Both direct and indirect techniques can be used to perform anthropometric measurements and qualitative assessments. The most accurate anthropometric method is direct anthropometry, which is the gold standard but requires general anesthesia in young kids. Two dimensional (2D) images can be used for indirect anthropometry; however, calibration and image distance standardization are needed for linear measurements.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • Giza, Cairo, Egypt, 11074
      • Faculty of medicine Cairo University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Infants with unilateral isolated cleft lip aged from 2-6 months
• Infants with incomplete and complete unilateral cleft lip(reach floor of the nose)

Exclusion Criteria:

• Infants less than 2 months or more than 6 months
• Bilateral cleft lip patients
• Recurrent repair cleft lip cases
• Facial cleft cases 5-Syndromic patients cases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control group; 21normal infant aged 3-6 months	Procedure: Unilateral cleft lip repair; Surgical repair unilateral cleft lip
Other: Group a; 21 patient of unilateral cleft lip had mishra technique repair	Procedure: Unilateral cleft lip repair; Surgical repair unilateral cleft lip
Other: Group b; 21 patient of unilateral cleft lip had modified Millard technique repair	Procedure: Unilateral cleft lip repair; Surgical repair unilateral cleft lip

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical repair unilateral cleft lip measurements	Vertical lip height; Horizontal lip length; Philtral length	At 3 months post operative

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Kasr Elainy, Cairo university Egypt

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: February 16, 2023
• First Submitted That Met QC Criteria: February 25, 2023
• First Posted (Estimate): February 28, 2023

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 25, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Mouth Diseases; Lip Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Cleft Lip
• Other Study ID Numbers: MD-40-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Shared for every one
• IPD Sharing Time Frame: Once publication
• IPD Sharing Access Criteria: Open for every one
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No