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

Periodontal Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02180932
• Other study ID #: 13-GIRCI-01
• Status: Completed
• Phase: N/A
• First received: May 20, 2014
• Last updated: October 23, 2015
• Start date: June 2014

Study information

• Verified date: May 2014
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Gingival Diseases
• Periodontal Disease
• Periodontal Diseases

Intervention

Biological:
• periodontal pocket samples

Locations

Country	Name	City	State
France	Hôpital saint Roch	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of level of EBV nucleic acids		day 1	No
Primary	Measure of level of EBV nucleic acids		day 180	No