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Longitudinal clinical and micorbiological assessment of oral health in patients undergoing radiation in the head and neck area

Longitudinal clinical and micorbiological assessment of oral health in patients undergoing radiation in the head and neck area - RADPAR

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00037774
Enrollment
50
Registered
2025-08-26
Start date
2026-01-12
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

K05 K02 K03 K04 K06 C01 C02 C03 C04 C05 C06

Interventions

Group 1: Observational group: Patients undergoing radiation in the head and neck area because of an HNSCC (head and neck squamous cell carcinoma) Group 2: Control: Patients with no anamnestic or plann

Sponsors

Klinik für Zahnerhaltungskunde und Parodontologie, Universitäsklinikum Freiburg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Voluntary consent and written signature of the information sheet At least five remaining teeth Consent to regular participation in supportive periodontitis therapy at the Clinic for Conservative Dentistry and Periodontology for the duration of the study

Exclusion criteria

Exclusion criteria: Medication with bisphosphonates or Denosumab. Second carcinoma in the head and neck area

Design outcomes

Primary

MeasureTime frame
Changes in the periodontal status (sounding depth and attachmentlevel) before and after radiation

Secondary

MeasureTime frame
1) Changes of periodontal parameters (sounding depth and attachmentlevel) after radiation of the head and neck area. 2) WHO Mucositits Score before and after radiation. 3) areaspecific radiation dose per tooth. 4) Diversity of the oral microbiome of dental plaque and saliva before and after radiation. 5) Perception of the oral health as recorded with the Oral Health Impact Profile questionaire. 6) Salivary flow rate before and after radiation. 7) Prevalence of osteoradionecrosis of the jaw. 8) Number of identified proteins in saliva and crevicular fluid samples. 9) Intensity of identified proteins in saliva and crevicular fluid samples.

Countries

Germany

Contacts

Public ContactTim Halstenbach

Klinik für Zahnerhaltungskunde und Parodontologie, Universitätsklinikum Freiburg

tim.halstenbach@uniklinik-freiburg.de076127048850

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026