Towards a Viral Etiology of Periodontal Disease in Relation to Radiotherapy Treatment of Head and Neck Cancers
Primary Purpose
Periodontal Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
periodontal pocket samples
Sponsored by
About this trial
This is an interventional basic science trial for Periodontal Disease
Eligibility Criteria
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
Sites / Locations
- Hôpital saint Roch
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
periodontal disease
Arm Description
Saliva samples
Outcomes
Primary Outcome Measures
Measure of level of EBV nucleic acids
Measure of level of EBV nucleic acids
Secondary Outcome Measures
Full Information
NCT ID
NCT02180932
First Posted
May 20, 2014
Last Updated
October 23, 2015
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT02180932
Brief Title
Towards a Viral Etiology of Periodontal Disease in Relation to Radiotherapy Treatment of Head and Neck Cancers
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
periodontal disease
Arm Type
Experimental
Arm Description
Saliva samples
Intervention Type
Biological
Intervention Name(s)
periodontal pocket samples
Primary Outcome Measure Information:
Title
Measure of level of EBV nucleic acids
Time Frame
day 1
Title
Measure of level of EBV nucleic acids
Time Frame
day 180
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hôpital saint Roch
City
Nice
Country
France
12. IPD Sharing Statement
Learn more about this trial
Towards a Viral Etiology of Periodontal Disease in Relation to Radiotherapy Treatment of Head and Neck Cancers
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