Towards a Viral Etiology of Periodontal Disease in Relation to Radiotherapy Treatment of Head and Neck Cancers
1 other identifier
interventional
25
1 country
1
Brief Summary
The treatment of otolaryngology (OLR) cancer is based on surgery, radiation, sometimes used in combination with chemotherapy. Patients treated with radiotherapy have multiple oral diseases: mucositis, hyposalivation, tissue fibrosis, exacerbation of periodontitis. Over 70% of patients with head and neck cancers treated with radiotherapy have a lower level of dental clinical attachment and 92% have loose teeth or missing. The management of these oral complications is a priority in OLR oncology. The aim is to improve the oral health of patients to achieve a comfortable life acceptable and necessary for healing. This project proposes to deepen the investigation with two main objectives:
- 1.To study in vivo the effect of radiation treatment on the evolution of the viral flora of the periodontium in a cohort of patients and matched controls.
- 2.To study in vitro the effects of irradiation on the replication EBV (herpesvirus) in producing websites lymphoepithelial tonsillar, and atypical dendritic cells associated with EBV that existence were recently discovered.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2014
CompletedFirst Posted
Study publicly available on registry
July 3, 2014
CompletedStudy Start
First participant enrolled
October 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 3, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 3, 2015
CompletedMarch 24, 2026
March 1, 2026
9 months
May 20, 2014
March 20, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Measure of level of EBV nucleic acids
day 1
Measure of level of EBV nucleic acids
day 180
Study Arms (1)
periodontal disease
EXPERIMENTALSaliva samples
Interventions
Eligibility Criteria
You may qualify if:
- Patients ≥ 18 years
- Patients treated with curative radiotherapy on tumor site or surgery for cancer of the oral cavity and / or oropharynx
- Patients naive treatments for head and neck cancers
- Patients affiliated or beneficiary of a social security scheme
- Patients who gave informed consent in writing
You may not qualify if:
- Patients treated with neoadjuvant chemotherapy, adjuvant or concomitant
- Patients taking immunosuppressants after organ transplantation
- Taking anticoagulants incompatible with dental samples (possible bleeding)
- Patients edentulous and / or whose dental condition is incompatible with the dental samples
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital saint Roch
Nice, France
Related Publications (1)
De Monte A, Olivieri CV, Vitale S, Bailleux S, Castillo L, Giordanengo V, Maryanski JL, Segura E, Doglio A. CD1c-Related DCs that Express CD207/Langerin, but Are Distinguishable from Langerhans Cells, Are Consistently Present in Human Tonsils. Front Immunol. 2016 May 25;7:197. doi: 10.3389/fimmu.2016.00197. eCollection 2016.
PMID: 27252701RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2014
First Posted
July 3, 2014
Study Start
October 20, 2014
Primary Completion
July 3, 2015
Study Completion
December 3, 2015
Last Updated
March 24, 2026
Record last verified: 2026-03