Parodontitis AggressiveNCT01246648
Chronic Presence of Epstein Barr Virus in Sulcular and Junctional Epithelial Tissue From Gingiva is Associated With Severe Periodontitis
A study testing Biopsy in people with Parodontitis Aggressive and Parodontitis Chronic, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
The etiopathogenesis of periodontal disease results from complex interaction between infectious agents, mainly including bacteria, and host cellular and humoral immune responses. Read more about this study
- Who is it for?
- Ages 12 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Parodontitis Aggressive, Parodontitis Chronic
- What is being tested?
- Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jan 2011to 1 Apr 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 12 years and older
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Men exclusively
- 12 years minimum
- 2 patients affected by chronic periodontitis
- 2 patients affected by aggressive periodontitis
- 2 healthy patients (orthodontics extraction)
- Subject who have read and understood the information note relative under investigation and who have signed the informed consent
- Subject whose legal representative signed the parental consent (if minor patient)
Who cannot join
- Patient with contre-indication to dental extraction
- Patient witn serious blood disease
- Patient who exhibits systemic condition incompatible with the realization of the study
- Patient treated with oral retinoids, bisphosphonates, oral anticoagulants and anticonvulsivants
- Patient who presents za buccal carcinoma treated with radiotherapy
- Patient who have received during the past 6 months: anti-inflammatory drugs, anti-cancerous or immunosuppressive chemiotherapy
- Patient who presents a linguistic or psychic incapacity to understand information
- Female patient
Trial locations and contacts
1 site in 1 country.
About this study
The etiopathogenesis of periodontal disease results from complex interaction between infectious agents, mainly including bacteria, and host cellular and humoral immune responses. However it is thought that bacteria-induced pathogenesis is not sufficient alone to explain all biological and clinical features of the destructive periodontal disease. The main hypothesis is that herpesviruses, such as Epstein-Barr Virus, may participate as well by altering epithelial gingival cell biology and consequently may promote the initiation and progression of periodontitis.
- Conditions
- Parodontitis Aggressive, Parodontitis Chronic
- Being tested
- Biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
dental extraction and gingival epithelial biopsy
biopsyProcedure or surgery
dental extraction and gingival epithelial biopsy
BiopsyProcedure or surgery
dental extraction and gingival epithelial biopsy
| Study group | Role | What they receive |
|---|---|---|
| chronic periodontitis | Active comparator | Not described Receives: Procedure: Biopsy |
| agressive periodontitis | Active comparator | Not described Receives: Procedure: biopsy |
| healthy patients | Active comparator | Not described Receives: Procedure: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence/absence of EBV in the epithelial cells of periodontal pockets (by Immunofluorescence and in situ Hybridization
Measured: at time = 0 (baseline)
Secondary outcomes (2)
Presence/ absence of latency and/or lytic proteins (by immunofluorescence and in situ hybridization
Measured: at time = 0 (baseline)
- Epithelial tissue infected (by Immunofluorescence and In situ Hybridization) : detection of oral gingival epithelium, sulcular epithelium, junctional epithelium.
Measured: at time = 0 (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2010 (estimated)
- Study start17 Jan 2011
- Primary completion1 Apr 2015
- Study completion1 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parodontitis AggressiveStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- VINCENT Severine, PH, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01246648
- Sponsor's protocol ID
- 10-PP-13
- Status last verified
- Jun 2024
- First submitted
- 17 Nov 2010
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Presence of Epstein Barr Virus in Sulcular and Junctional Epithelial Tissue From Gingiva is Associated With Severe Periodontitis
- ClinicalTrials.gov ID
- NCT01246648
- Acronym / sponsor ID
- 10-PP-13
- Conditions
- Parodontitis Aggressive, Parodontitis Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 17 Jan 2011 (actual)
- Primary completion
- 1 Apr 2015 (actual)
- Study completion
- 1 Apr 2015 (actual)
- First posted
- 23 Nov 2010 (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 etiopathogenesis of periodontal disease results from complex interaction between infectious agents, mainly including bacteria, and host cellular and humoral immune responses. However it is thought that bacteria-induced pathogenesis is not sufficient alone to explain all biological and clinical features of the destructive periodontal disease. The main hypothesis is that herpesviruses, such as Epstein-Barr Virus, may participate as well by altering epithelial gingival cell biology and consequently may promote the initiation and progression of periodontitis.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| chronic periodontitis | Active comparator | Procedure: Biopsy |
| agressive periodontitis | Active comparator | Procedure: biopsy |
| healthy patients | Active comparator | Procedure: Biopsy |
Who may qualify
- Ages
- 12 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Men exclusively
- 12 years minimum
- 2 patients affected by chronic periodontitis
- 2 patients affected by aggressive periodontitis
- 2 healthy patients (orthodontics extraction)
Key exclusion criteria (8 listed)
- Patient with contre-indication to dental extraction
- Patient witn serious blood disease
- Patient who exhibits systemic condition incompatible with the realization of the study
- Patient treated with oral retinoids, bisphosphonates, oral anticoagulants and anticonvulsivants
- Patient who presents za buccal carcinoma treated with radiotherapy
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 |
|---|---|---|
| Biopsydental extraction and gingival epithelial biopsy | Procedure or surgery | chronic periodontitis |
| biopsydental extraction and gingival epithelial biopsy | Procedure or surgery | agressive periodontitis |
| Biopsydental extraction and gingival epithelial biopsy | Procedure or surgery | healthy patients |
Primary outcome
Presence/absence of EBV in the epithelial cells of periodontal pockets (by Immunofluorescence and in situ Hybridization
Time frame: at time = 0 (baseline)
2 secondary outcomes
Presence/ absence of latency and/or lytic proteins (by immunofluorescence and in situ hybridization
Time frame: at time = 0 (baseline)
- Epithelial tissue infected (by Immunofluorescence and In situ Hybridization) : detection of oral gingival epithelium, sulcular epithelium, junctional epithelium.
Time frame: at time = 0 (baseline)
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 27 Jun 2024.
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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.
VINCENT Severine, PH principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy in people with Parodontitis Aggressive and Parodontitis Chronic, 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 7 inclusion and 8 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 27 Jun 2024. 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?
Presence/absence of EBV in the epithelial cells of periodontal pockets (by Immunofluorescence and in situ Hybridization (time frame: at time = 0 (baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2024.