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

NCT ID: NCT02180932

Last Updated: 2015-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Brief Summary

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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

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Conditions

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Periodontal Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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periodontal disease

Saliva samples

Group Type EXPERIMENTAL

periodontal pocket samples

Intervention Type BIOLOGICAL

Interventions

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periodontal pocket samples

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital saint Roch

Nice, , France

Site Status

Countries

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France

Other Identifiers

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13-GIRCI-01

Identifier Type: -

Identifier Source: org_study_id

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