Periodontal DiseaseNCT02180932
Towards a Viral Etiology of Periodontal Disease in Relation to Radiotherapy Treatment of Head and Neck Cancers
A study testing periodontal pocket samples in people with Periodontal Disease, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Periodontal Disease
- What is being tested?
- periodontal pocket samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 20 Oct 2014to 3 Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Periodontal Disease
- Being tested
- periodontal pocket samples
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
periodontal pocket samplesBiological
| Study group | Role | What they receive |
|---|---|---|
| periodontal disease | Experimental | Saliva samples Receives: Biological: periodontal pocket samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of level of EBV nucleic acids
Measured: day 1
Measure of level of EBV nucleic acids
Measured: day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2014 (estimated)
- Study start20 Oct 2014
- Primary completion3 Jul 2015
- Study completion3 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02180932
- Sponsor's protocol ID
- 13-GIRCI-01
- Status last verified
- Mar 2026
- First submitted
- 20 May 2014
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
De Monte A, Olivieri CV, Vitale S, Bailleux S, Castillo L, Giordanengo V, Maryanski JL, Segura E, Doglio A. CD1c-Related DCs that Express CD207/Langerin, but Are Distinguishable from Langerhans Cells, Are Consistently Present in Human Tonsils. Front Immunol. 2016 May 25;7:197. doi: 10.3389/fimmu.2016.00197. eCollection 2016.
PubMed 27252701
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards a Viral Etiology of Periodontal Disease in Relation to Radiotherapy Treatment of Head and Neck Cancers
- ClinicalTrials.gov ID
- NCT02180932
- Acronym / sponsor ID
- 13-GIRCI-01
- Conditions
- Periodontal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 20 Oct 2014 (actual)
- Primary completion
- 3 Jul 2015 (actual)
- Study completion
- 3 Dec 2015 (actual)
- First posted
- 3 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| periodontal disease | Experimental | Biological: periodontal pocket samplesSaliva samples |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| periodontal pocket samples | Biological | periodontal disease |
Primary outcome
Measure of level of EBV nucleic acids
Time frame: day 1
Measure of level of EBV nucleic acids
Time frame: day 180
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Results publication: PubMed 27252701De Monte A, Olivieri CV, Vitale S, Bailleux S, Castillo L, Giordanengo V, Maryanski JL, Segura E, Doglio A. CD1c-Related DCs that Express CD207/Langerin, but Are Distinguishable from Langerhans Cells, Are Consistently Present in Human Tonsils. Front Immunol. 2016 May 25;7:197. doi: 10.3389/fimmu.2016.00197. eCollection 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing periodontal pocket samples in people with Periodontal Disease, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of level of EBV nucleic acids (time frame: day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02180932, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.