Chronic PeriodontitisNCT01246596
Chronic Presence of Epstein Barr Virus in Epithelial Cells From Gingiva is Associated With Periodontitis
A study testing dental root planing in people with Chronic Periodontitis and Aggressive Periodontitis, 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 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis, Aggressive Periodontitis, Presence / Absence of EBV
- What is being tested?
- dental root planing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2011to 5 May 2014
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 10 patients affected by chronic periodontitis
- 10 patients affected by aggressive periodontitis
- 10 healthy patients (orthodontics extraction)
- Subject who have read and understood the information note relative under investigation and who have signed the informed consent
- major patient
Who cannot join
- Patient with no contre-indication to periodontal treatment
- Patient with serious blood disease
- Patient who exhibits systemic condition incompatible with realization of the study
- Patient treated with oral retinoids, bisphosphonates, oral anticoagulants and anticonvulsivants
- Patient who presents a 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
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.
- Being tested
- dental root planing
- Medical subject headings
- Chronic Periodontitis, Aggressive Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental root planingProcedure or surgery
The objective of root planing, otherwise known as conventional periodontal therapy, non-surgical periodontal therapy, or dental prophylaxis is to remove or eliminate the etiologic agents which cause inflammation: dental plaque, its products and calculus,[1] thus helping to establish a periodontium that is free of disease.[2]
dental root planingProcedure or surgery
The objective of root planing, otherwise known as conventional periodontal therapy, non-surgical periodontal therapy, or dental prophylaxis is to remove or eliminate the etiologic agents which cause inflammation: dental plaque, its products and calculus, thus helping to establish a periodontium that is free of disease.
dental root planingProcedure or surgery
The objective of root planing, otherwise known as conventional periodontal therapy, non-surgical periodontal therapy, or dental prophylaxis is to remove or eliminate the etiologic agents which cause inflammation: dental plaque, its products and calculus, thus helping to establish a periodontium that is free of disease.
| Study group | Role | What they receive |
|---|---|---|
| chronic periodontitis | Active comparator | Not described Receives: Procedure: dental root planing |
| aggressive periodontitis | Active comparator | Not described Receives: Procedure: dental root planing |
| healthy patient (orthodontics extraction) | Active comparator | Not described Receives: Procedure: dental root planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of gingival epithelial cells infected by EBV (by immunofluorescence and In situ Hybridization)
Measured: at time=0
Secondary outcomes (2)
Epithelial tissue infected by EBV (by immunofluorescence and in situ hybridization)
Measured: at time = 0
Presence / absence of latency and / or lytic proteins (by immunofluorescence and in situ hybridization)
Measured: at time = 0
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 startJan 2011
- Primary completion5 May 2014
- Study completion5 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriodontitisStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Severine VINCENT, PH, Principal investigator, CHU de Nice Hôpital Saint Roch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01246596
- Sponsor's protocol ID
- 10-AOI-01
- Status last verified
- Nov 2023
- First submitted
- 17 Nov 2010
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Presence of Epstein Barr Virus in Epithelial Cells From Gingiva is Associated With Periodontitis
- ClinicalTrials.gov ID
- NCT01246596
- Acronym / sponsor ID
- 10-AOI-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- 5 May 2014 (actual)
- Study completion
- 5 May 2014 (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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| chronic periodontitis | Active comparator | Procedure: dental root planing |
| aggressive periodontitis | Active comparator | Procedure: dental root planing |
| healthy patient (orthodontics extraction) | Active comparator | Procedure: dental root planing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 10 patients affected by chronic periodontitis
- 10 patients affected by aggressive periodontitis
- 10 healthy patients (orthodontics extraction)
- Subject who have read and understood the information note relative under investigation and who have signed the informed consent
- major patient
Key exclusion criteria (7 listed)
- Patient with no contre-indication to periodontal treatment
- Patient with serious blood disease
- Patient who exhibits systemic condition incompatible with realization of the study
- Patient treated with oral retinoids, bisphosphonates, oral anticoagulants and anticonvulsivants
- Patient who presents a 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 |
|---|---|---|
| dental root planingThe objective of root planing, otherwise known as conventional periodontal therapy, non-surgical periodontal therapy, or dental prophylaxis is to remove or eliminate the etiologic agents which cause inflammation: dental plaque, its products and calculus,[1] thus helping to establish a periodontium that is free of disease.[2] | Procedure or surgery | chronic periodontitis |
| dental root planingThe objective of root planing, otherwise known as conventional periodontal therapy, non-surgical periodontal therapy, or dental prophylaxis is to remove or eliminate the etiologic agents which cause inflammation: dental plaque, its products and calculus, thus helping to establish a periodontium that is free of disease. | Procedure or surgery | aggressive periodontitis |
| dental root planingThe objective of root planing, otherwise known as conventional periodontal therapy, non-surgical periodontal therapy, or dental prophylaxis is to remove or eliminate the etiologic agents which cause inflammation: dental plaque, its products and calculus, thus helping to establish a periodontium that is free of disease. | Procedure or surgery | healthy patient (orthodontics extraction) |
Primary outcome
Percentage of gingival epithelial cells infected by EBV (by immunofluorescence and In situ Hybridization)
Time frame: at time=0
2 secondary outcomes
Epithelial tissue infected by EBV (by immunofluorescence and in situ hybridization)
Time frame: at time = 0
Presence / absence of latency and / or lytic proteins (by immunofluorescence and in situ hybridization)
Time frame: at time = 0
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 13 Nov 2023.
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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.
Severine VINCENT, PH principal investigator
CHU de Nice Hôpital Saint Roch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dental root planing in people with Chronic Periodontitis and Aggressive Periodontitis, 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 7 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 13 Nov 2023. 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?
Percentage of gingival epithelial cells infected by EBV (by immunofluorescence and In situ Hybridization) (time frame: at time=0). 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 13 Nov 2023.