Towards a Viral Etiology of Periodontal Disease in Relation to Radiotherapy Treatment of Head and Neck Cancers

Not Applicable

Completed

• Conditions: Periodontal Disease
• Interventions: Biological: periodontal pocket samples

• Registration Number: NCT02180932
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-05
• Study First Submitted: 2014-05-20
• Study Start: 2014-06
• Study First Submitted QC: 2014-07-01
• Study First Posted: 2014-07-03
• Primary Completion: 2015-07
• Last Update Submitted: 2015-10-23
• Last Update Posted: 2015-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
periodontal disease	periodontal pocket samples	Saliva samples

Primary Outcome Measures

Name	Time	Method
Measure of level of EBV nucleic acids	day 180

Trial Locations

Locations (1)

Hôpital saint Roch; 🇫🇷 Nice, France