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

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Disease
• Intervention / Treatment: Biological: periodontal pocket samples

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nice, France
    • Hôpital Saint Roch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: periodontal disease; Saliva samples	Biological: periodontal pocket samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measure of level of EBV nucleic acids	day 1
Measure of level of EBV nucleic acids	day 180

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: May 20, 2014
• First Submitted That Met QC Criteria: July 1, 2014
• First Posted (Estimate): July 3, 2014

Study Record Updates

• Last Update Posted (Estimate): October 26, 2015
• Last Update Submitted That Met QC Criteria: October 23, 2015
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases
• Other Study ID Numbers: 13-GIRCI-01