Clinical trial · Observational
The Characterisation of RT Caries.
The Characterisation of Therapeutic Radiation-induced Caries; the Histopathological, Ultrastructural and Microbial Changes Affecting Its Prevention and Treatment.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Overcoming limitations of previous studies, the following research project will assess the most significant acute and long-term complications of RT that affect HNC patients: oral mucositis, dry mouth feeling, taste alteration and carious lesion incidence, all of which negatively affect cancer treatment outcomes and the quality of life of cancer survivors. This project was developed with an aim to study any possible correlations / links between the oral sequelae of RT and the negative clinical outcomes listed, in order to help the development of clinical management protocols for HNC patients to mitigate the effect on care and patient comfort and its delivery in healthcare systems. The project comprises of a longitudinal cohort study of HNC patients correlating biodata of biochemical salivary parameters, clinical outcomes and oral health status over a period up to 12 months post-RT, focusing on baseline pre-IMRT (T0), 6 months post-IMRT (T1) and up to 12 months post-IMRT treatments (T2). The ultimate goal is to identify possible predictive markers in the saliva at T0 to assist with evaluation of oral mucositis severity in individual HNC patients prior to start of treatment so that treatment can be adapted for such high-risk patients individually, to either prevent or minimise the severity of this consequence of RT.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Radiotherapy Side Effect | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- head and neck cancer pre RT
- description
- head and neck cancer patients before and after RT
- label
- head and neck cancer treated
- description
- head and neck cancer patients treated with radiotherapy
- label
- control group
- description
- age gender matched subjects
Primary outcomes (1)
- measure
- Effects of IMRT on saliva composition and potential associations with oral side effects
- timeFrame
- october 2019
- description
- integrated longitudinal study of HNC patients correlating biodata of biochemical parameters, clinical parameters and oral health status
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Head and Neck Cancer Patients Male or female Over the age of 18. Received radiation treatment for Head and Neck cancer Exclusion Criteria: Subjects younger than 18. Patients unable to give consent. Patients with non-controlled systemic disease Distant metastases Patients who have been administered antibiotics in the previous 3 months Patients with Sjogren syndrome. Patients with Rheumatoid arthritis Neurological disorders (Parkinson's disease) Dehydration Sialoadenitis Sialolithiasis
References
Publications (0)
Data not yet available