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

• Conditions: E70.0; Classical phenylketonuria

• Registration Number: DRKS00027482
• Lead Sponsor: Charité Universitätsmedizin Berlin Institut für Zahn-, Mund- und Kieferheilkunde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-06-21
• Study Start: 2022-01-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 223

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 PK

Exclusion Criteria

Antibiotic therapy in the last 12 weeks before the examination

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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