The impact of cleft lip and palate (CLP) on the oral microbiome, the local immune response and clinical parameters during interdisciplinary orthodontic treatments
Recruiting
- Conditions
- Q35-Q37Cleft lip and cleft palate
- Registration Number
- DRKS00033429
- Lead Sponsor
- Poliklinik für Kieferorthopädie, Ludwig-Maximilians-Universität München
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 974
Inclusion Criteria
Newborns with cleft lip and palate and their mothers
- Newborns without cleft lip and palate malformation and their mothers
- Children and adolescents with cleft lip and palate
- Children and adolescents without cleft lip and palate malformation
Exclusion Criteria
Withdrawal of the declaration of consent by the parents/legal guardians
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is the difference between the study group (patients with cleft lip and palate) and the control group (patients without cleft malformation) regarding the oral microbiome (alpha diversity) per study time point.<br>Sample collection from different oral niches (tongue, cleft margin, gingival crevicular fluid) and investigation of the oral microbiome using 16SrRNA sequenzierung.
- Secondary Outcome Measures
Name Time Method