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Completed

NCT Number: NCT04607213

Effectiveness of Rotation-advancement and Straight-line Surgical Approaches in Repairing Unilateral Cleft Lip Defect

compare different effects of Rotation-advancement based on the Millard technique and Straight-line based on Fisher modification as surgical approaches in repairing lip defect of unilateral cleft lip patients.

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Key information

Conditions

Unilateral Cleft Lip

Age range

1 day–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Azarita, 00203, Egypt

About this study

Twelve participants with unilateral cleft lip equally divided into two groups. Both groups were photographed preoperative and postoperative. The Control group treated using (Rotation-advancement) based on the Millard technique; and the test group treated using (Straight-line) technique based on Fisher modification.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have complete unilateral cleft lip
  • from birth to 4 years old

Exclusion criteria

  • syndromic cleft patient

Treatment and study plan

Advancement-rotation approach based on Millard' for repairing lip defect.

Procedure

patients were treated using Millard technique is the downward rotation of the medial part of the flap, and lateral advancement of the flap to close and fill the defect. if more lip height is needed; "cut- as- you-go" by adding a back-cut incision at the end of his rotation incision down toward the philtral ridge of non-clefted side. Moreover; C-flap is used to close nasal sill.

Straight-line approach

Procedure

patients were treated using Straight-Line design based on Fisher modification. C-shaped flap extend from the proposed nasal sill to the origin of philtral column of medial flap as a straight incision to the planned top of the cupid's bow. In addition, to the previous mentioned incision, small inlate incision is needed to length the cleft side on the medial flap.

On the other hand, on the lateral flap; two connected triangular incisions are used; one on the vermillion border at Noordhoff's point. And the other one just above the cutaneous margin to improve aesthetic outcome and diminish formed scar.

Primary outcomes

  1. change in vertical and horizontal lip length

    Time frame: at 3rd, 6th months

    Measuring vertical and horizontal lip length of the constructed philtral ridge by caliper

  2. change in lip defect

    Time frame: at 1st, 3rd and 6th months

    repaired lip is evaluated by direct visual inspection for the patient evaluation.

Secondary outcomes

  1. change in degree of labial scaring

    Time frame: at 3rd, 6th months

    Using a five-point scale based on Asher-McDade scoring system:

    (very good, good, fair, poor, very poor on a scale of 1-5, where 5 represents very poor and 1 represent very good).

  2. change in nasal symmetry

    Time frame: at 3rd, 6th months

    measuring total nasal width and nostril width by caliper

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

Comparison of Rotation- Advancement and Straight-line Methods for Repairing of Unilateral Cleft Lip (Randomized Controlled Clinical Trial)

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 29, 2020
Registry last updated
Oct 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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