Three-dimensional documentation and evaluation of the nasolabial region of children with cleft lip and palate

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00032280

Enrollment

100

Registered

2023-07-20

Start date

2023-07-11

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Q36 Q37 Q35

Interventions

Group 1: Children with cleft lip and palate who are coming to the Department of Oral and Maxillofacial Surgery at the Universityhospital Erlangen will undergo a contactless, non-invasive 3D scan of th

at 2 and 4 months of age

at 6 months of age (if applicable: immediately before and after surgical cleft lip closure)

at 12 months of age (if applicable: immediately before and after surgical cleft palate closure)

at 18 and 30 months of age). The children will be included in the study if a primary surgical treatment (cleft lip and/or palate closure) is still pending at the time of recruitment.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ICD-10 diagnosis Q35/Q36/Q37

Exclusion criteria

Exclusion criteria: No primary surgical interventions (lip and/or palate cleft closure) required at the time of inclusion in the study.

Design outcomes

Primary

Measure	Time frame
The aim of the study is to evaluate the morphology of the nasolabial region of children with cleft lip and palate in a time course before and after surgical cleft closures with the help of a 3D scan (TRIOS 4/TRIOS 5 scanner, 3Shape). Data acquisition shall be carried out up to 30 months of age.	—

Countries

Germany

Contacts

Public ContactRainer Lutz

Mund-, Kiefer- und Gesichtschirurgische Klinik des Universitätsklinikums Erlangen

rainer.lutz@uk-erlangen.de+49 9131 85 33601

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026