Unilateral Cleft Lip Closure - Development of a New Hybrid Technique

• ClinicalTrials.gov Identifier: NCT05102513
• Recruitment Status: Recruiting
• First Posted: November 1, 2021
• Last Update Posted: May 19, 2022
• Sponsor: Marco Kesting
• Information provided by (Responsible Party): Marco Kesting, University Hospital Erlangen

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Complete Unilateral Cleft Lip	Procedure: Unilateral Cleft Lip Repair: Hybrid Technique; Procedure: Unilateral Cleft Lip Repair: Millard 2 Technique	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: 20 complete unilateral cleft lips are operated; 10 are treated with the Millard II technique and 10 are treated with the new hybrid technique
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Unilateral Cleft Lip Closure - Development of a New Hybrid Technique
• Actual Study Start Date: May 1, 2022
• Estimated Primary Completion Date: May 1, 2023
• Estimated Study Completion Date: November 1, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Unilateral Cleft Lip Repair with the New Hybrid Technique	Procedure: Unilateral Cleft Lip Repair: Hybrid Technique; The rotation flap of the Millard II technique was expanded 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 lengthened by a wave cut as known from the Pfeiffer procedure. For the vermillion a Noordhoff plasty is applied.
Active Comparator: Unilateral Cleft Lip Repair with the Millard II Technique	Procedure: Unilateral Cleft Lip Repair: Millard 2 Technique; A curved incision is marked skirting the philtral ridge. If more length is required a back-cut incision can be performed. The C-flap is outlined by the incision just marked and the incision along red-white border up to the base of the columella. On the cleft side an advancement flap is designed. For the vermillion a Noordhoff plasty is applied.

Outcome Measures

Primary Outcome Measures :

1. Measurement of the length of the philtral colomn on the cleft and non-cleft side [ Time Frame: 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.
2. Angle of the columella [ Time Frame: 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.
3. Distance from the midpoint of the columella to the lateral alae [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 2 Months to 12 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Complete unilateral cleft lip and palate

Exclusion Criteria:

-

Contacts and Locations

Contacts

Contact: Marco Kesting, Prof Dr Dr; +49 9131 8533601; mkg-chirurgie@uk-erlangen.de

Contact: Jan Buerstner; +491712740291; jan.buerstner@fau.de

Locations

Germany

Mund-, Kiefer- und Gesichtschirurgische Klinik; Recruiting

Erlangen, Bayern, Germany, 91054

Sponsors and Collaborators

Marco Kesting

Investigators

• Principal Investigator: Marco Kesting, Prof Dr Dr; Mund-, Kiefer- und Gesichtschirurgie Erlangen

More Information

• Responsible Party: Marco Kesting, Prof. Dr. med. Dr. med. dent., University Hospital Erlangen
• ClinicalTrials.gov Identifier: NCT05102513
• Other Study ID Numbers: 20211010
• First Posted: November 1, 2021
• Last Update Posted: May 19, 2022
• Last Verified: May 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marco Kesting, University Hospital Erlangen:

Cleft Lip; Cleft Lip Repair; Unilateral Cleft Lip

Additional relevant MeSH terms:

Cleft Lip; Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities