The dental status and oral microbiome of children and adults with phenylketonuria. A nation-based cross-sectional study.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00027482

Enrollment

200

Registered

2022-01-03

Start date

2018-09-24

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

E70.0

Interventions

Group 1: control group Group 2: siblings Group 3: Patients with phenylketonuria

Eligibility

Sex/Gender

All

Age

6 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. patients with PKU: phenylalanine-reduced diet and taking a phenylalanine-free amino acid preparation 2. control group: metabolically healthy individuals and siblings of patients with PKU

Exclusion criteria

Exclusion criteria: Antibiotic therapy in the last 12 weeks before the examination

Design outcomes

Primary

Measure	Time frame
Caries: detection using DMFT/dmft/DMFT+dmft (Decayed/Missing/Filled Teeth in permanent dentition/ primary dentition/ mixed dentition) Oral microbiome: determination by Next Generation Sequencing in stimulated saliva and subgingival plaque	—

Secondary

Measure	Time frame
Enamel defects: Determination with DDE (Developmental Defects of Enamel according to Dean) Gingivitis/periodontitis/oral hygiene: Determination with GBI (Gingival Bleeding Index), PCR (Plaque Control Record), PSI (Periodontal Screening Index) Tooth erosion: Determination with BEWE (Basic Erosive Wear Examination)	—

Countries

Germany

Contacts

Public ContactAnne Carolin Steinbeck

Charité Universitätsmedizin Berlin Institut für Zahn-, Mund- und Kieferheilkunde

anne-carolin.steinbeck@charite.de01626847000

Outcome results

None listed

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