Skip to content

Unilateral Cleft Lip Closure - Development of a New Hybrid Technique

Unilateral Cleft Lip Closure - Development of a New Hybrid Technique

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05102513
Enrollment
20
Registered
2021-11-01
Start date
2022-05-01
Completion date
2023-11-01
Last updated
2022-05-19

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

Conditions

Complete Unilateral Cleft Lip

Keywords

Cleft Lip, Cleft Lip Repair, Unilateral Cleft Lip

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.

Interventions

PROCEDUREUnilateral 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.

PROCEDUREUnilateral 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.

Sponsors

Marco Kesting
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

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

Eligibility

Sex/Gender
ALL
Age
2 Months to 12 Months
Healthy volunteers
No

Inclusion criteria

* Complete unilateral cleft lip and palate

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Distance from the midpoint of the columella to the lateral alaeperioperativelyPerioperatively, 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 columellaperioperativelyA 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.
Measurement of the length of the philtral colomn on the cleft and non-cleft sideperioperatively to 6 month postoperativelyPerioperatively, 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.

Countries

Germany

Contacts

Primary ContactMarco Kesting, Prof Dr Dr
mkg-chirurgie@uk-erlangen.de+49 9131 8533601
Backup ContactJan Buerstner
jan.buerstner@fau.de+491712740291

Outcome results

None listed

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