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Improved Oral Health in Head and Neck Cancer Survivors
Sponsor: Uppsala University
Summary
The goal of this clinical trial is to learn if an oral care programme, designed as a multicentre two-armed randomised controlled trial (RCT), can prevent or mitigate late oral sequalae following completion of head and neck cancer (HNC) treatment, and assessing its impact on health-related quality of life (HRQoL), oral health, work ability, nutritional status, psychological well-being, and healthcare-related economic costs. The intervention consists of an oral care programme given to the intervention group (HNC survivors) from six months after the end of treatment and every three months for three years. The main questions it aims to answer are: * Does the intervention improve oral health, nutritional status, HRQoL, and reduce stress and anxiety compared with standard care? * Does the intervention reduce the duration of sick leave and improve return-to-work outcomes compared with standard care? * Is the intervention cost-effective from a health economic perspective? * Does the intervention improve patients' self-efficacy in managing their oral health and related challenges compared with standard care? * Does the intervention influence self-reported oral health, oral health-related behaviours, and oral health knowledge over time compared with standard care? * Do the effects of the intervention differ according to age, sex and sociodemographic factors? * Does the intervention affect salivary composition and salivary biomarkers over time compared with standard care?
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2025-09-25
Completion Date
2045-09-23
Last Updated
2026-09-03
Healthy Volunteers
No
Interventions
Oral health support
The intervention group will receive examination and treatment by a dental hygienist every 3 months starting 6 months after completion of RT/CRT up to 3 years. During visits to the dental hygienist, they will be asked about oral hygiene habits, fluoride use, dry mouth problems, and dietary habits (including intake of easily degradable carbohydrates). Oral dryness will be assessed using the Clinical Oral Dryness Scale. The stimulated salivary secretion and buffering capacity will be assessed, and the ability to open the mouth, cariological and periodontal status and registered plaque. Based on the results of the clinical examination, the patient will get individually tailored advice and recommendations on oral hygiene, fluoride use, dry mouth relief, and support in reducing the intake of food items and drinks with high sugar content. Professional oral care will be given, and fluoride applications when indicated.
Locations (1)
Uppsala University
Uppsala, Sweden