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Dental and oral long-term complications of radio- and radio-chemotherapy in the head and neck area

Dental and oral long-term complications of radio- and radio-chemotherapy in the head and neck area

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00034708
Enrollment
20
Registered
2024-07-26
Start date
2025-01-01
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

C00-C14

Interventions

Group 1: Patients receive pre-treatment (removal of caries, filling therapy, periodontal pre-treatment, planning of extractions, impression for the distance/fluoridation splint) after inclusion in the

Sponsors

Medizinische Hochschule Hannover
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Tumor in the oral cavity, oropharynx, hypopharynx or larynx (corresponding to ICD codes C00 - C14), Primary or adjuvant radio- or radio-chemotherapy with curative therapy objective, German language skills, Informed Consent

Exclusion criteria

Exclusion criteria: Palliative tumor therapy; Previous radio therapy in the head and neck area; Pregnancy/breastfeeding period; Allergies to materials used; Small residual dentition (<10); Carious lesions not treated in the dental pre-treatment phase (ICDAS 3, 4, 5, 6); Deep, inflamed, periodontal pockets; Hyposalivation before the start of the study (unstimulated salivary flow rate < 0.1 ml/min or stimulated salivary flow rate < 0.7 ml/min; check during the baseline examination before the biopsy with subsequent exclusion if necessary); Serious blood clotting disorder; Known wound healing disorder.

Design outcomes

Primary

MeasureTime frame
Caries status (ICDAS), unstimulated/stimulated salivary flow rate & residual salivary flow rate (modified Schirmer test), oral mucositis score, cellular radiosensitivity, oral health-related quality of life questionnaire (OHIP-14)

Secondary

MeasureTime frame
Plaque index, periodontal probing depths, bleeding on probing, pH value of stimulated saliva, buffer capacity of stimulated saliva, questionnaire on xerostomia

Countries

Germany

Contacts

Public ContactBenedikt Luka

Medizinische Hochschule Hannover, Klinik für Zahnerhaltung, Parodontologie und Präventivzahnmedizin

luca.benedikt@mh-hannover.de+ 49 511 532 4833

Outcome results

None listed

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