Unilateral Cleft Lip Closure - Development of a New Hybrid Technique

Not Applicable

• Conditions: Complete Unilateral Cleft Lip

• Registration Number: NCT05102513
• Lead Sponsor: Marco Kesting

Brief Summary

Unilateral cleft lips can be treated with different incision techniques. According to a survey by the American Cleft Palate Association, the Millard II technique is currently used by the majority of US cleft surgeons. In this technique, a cleft-sided advancement flap is pivoted from the cleft side into the rotation flap of the non-cleft side, which serves, among other things, to lengthen the lip. However, the rotational component is often insufficient to sufficiently lengthen the lip on the cleft side. The result is a raised red lip, a shortened edge of the philtrum or a so-called pipe-hole deformity. In order to compensate for these "deficiencies", a triangular flap is currently being formed in the area of the white roll, which is intended to provide sufficient lengthening.

However, the scar of the triangular flaps runs exactly opposite to the aesthetic unit. In addition, it often provides a step formation within the white roll. Knowing the weaknesses of the previous techniques, a further development of the incision was made. The rotational flap of the Millard II technique was extended by extending the incision into the columella - similar to the well-known Mohler technique. The caudal part of the advancement flap of the Millard II technique was extended by a wave incision as known from the Pfeifer procedure.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-19
• Study First Submitted QC: 2021-10-19
• Study First Posted: 2021-11-01
• Status Verified: 2022-05
• Study Start: 2022-05-01
• Last Update Submitted: 2022-05-18
• Last Update Posted: 2022-05-19
• Primary Completion: 2023-05-01
• Study Completion: 2023-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Complete unilateral cleft lip and palate

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Measurement of the length of the philtral colomn on the cleft and non-cleft side	perioperatively to 6 month postoperatively	Perioperatively, a 3-D scan and photos are taken. Additional photos are also taken after the removal of the stitches, after 3 months and after 6 months. From these, the increase in length of the philtral column can be determined with 3D computer software and with a linear measurement of the photos.
Distance from the midpoint of the columella to the lateral alae	perioperatively	Perioperatively, a 3-D scan and photos are taken. The distance can be measured with a 3D computer software and with a linear measurement of the photos.
Angle of the columella	perioperatively	A 3d scan and photos are made perioperatively. From this the angle of the columella can be determined with a 3D Computer software and with a linear measurement of the photos.

Trial Locations

Locations (1)

Mund-, Kiefer- und Gesichtschirurgische Klinik; 🇩🇪 Erlangen, Bayern, Germany