Peri-ImplantitisDUOROPANCT02664675
Cellular and Molecular Inflammatory Mechanisms Leading to Bone Resorption in Peri-implantitis Vs Periodontitis
An observational study of Peri-Implantitis and Periodontitis, run by University of Paris 5 - Rene Descartes at 2 sites in France.
Trial summary
Recent data found that peri-implantitis may differ from periodontitis at the histological level in terms of extent and composition of the cellular components. From human biopsies, it has been shown a deeper apical extension of the inflammatory cell infiltrate and a larger proportion of granulocytes and macrophages in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peri-Implantitis, Periodontitis
- What is being tested?
- Crown lengthening and Open Flap Debridement
- Type of treatment
- Surgery or procedure
- How many people
- 33 participants
- Where
- 2 sitesFrance
- Study dates
- Apr 2014to Jan 2016
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated in periodontology department of Hospital Rotschild or Charles Foix
Who may be able to join
- Beneficiary by national health insurance
- Age: over 18 year-old
- Non smoking
- Good health
- ---For the periimplantitis group:
- patients formerly treated with a non surgical procedure without antibiotics with at least one functional dental implant with at least on pocket deeper than 5 mm with bleeding on probing and radiographical alveolar bone loss.
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- ---For the periodontitis group:
- patients formerly treated with a non surgical procedure without antibiotics for a generalized severe chronic periodontitis (in accord to Armitage 2009) and needing a resective surgical procedure (periodontal pockets deeper than 5 mm with bleeding on probing)
- ---For the healthy group:
- patients with good health without periodontal or peri implant disease needing gingivectomy (crown lengthening, esthetic surgery)
Who cannot join
- Smokers
- Patients treated with antibiotics or NSAID during the last 3 months
- Patients suffering from a chronic infectious, inflammatory or auto-immune disease (non equilibrated diabetes mellitus, rheumatoid arthritis, spondylarthrosis, Gougerot-Sjögren, Crohn, Behcet, Horton, obesity, chronic end renal disease, cardiopathies....)
- Pregnant women
- For the healthy group : bleeding on probing on the site.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hospital Charles Foix APHP
Ivry-sur-Seine, 94200
Hospital Rotschild
Paris
About this study
Official title: Comparison of Cytokines Production and Cellular Recruitment in Gingival Crevicular Fluid (GCF) and Granulation Tissue From Periodontitis, Peri-implantitis and Healthy Patients Leading to Activation of Osteoclasts and Bone Resorption
Recent data found that peri-implantitis may differ from periodontitis at the histological level in terms of extent and composition of the cellular components. From human biopsies, it has been shown a deeper apical extension of the inflammatory cell infiltrate and a larger proportion of granulocytes and macrophages in peri-implantitis lesions compared to periodontitis lesions. Following experimental peri-implantitis, it has been observed a continuing bone loss around dental implants after ligature removal; whereas, such a progression was not observed around teeth after cessation of the experimental periodontitis. The factors influencing the recruitment and the activation of osteoclasts in both diseases have not been compared yet.
Hypothesis : The more rapid and more severe alveolar bone destruction occurring in peri-implantitis compared to periodontitis is due at least in part to differences in the inflammatory process in these diseases.
Read more
Aim: to study the cytokine profile produced by gingival explants from periodontitis or peri-implantitis sites and to test the consequences on alteration of bone remodelling activity using in vitro approach.
Materials and methods The investigators will establish a collection of human gingival samples from patients undergoing surgical treatment of periodontitis or peri-implantitis. The investigators will test pro-inflammatory cytokines and chemokines release and consequences on osteoclast differentiation and activity.
- Conditions
- Peri-Implantitis, Periodontitis
- Being tested
- Crown lengthening, Open Flap Debridement
- Medical subject headings
- Peri-Implantitis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crown lengtheningProcedure or surgery
After a local anesthesia, gingival tissue is removed around the teeth to extend the length of the crown for aesthetic or prosthetic matter.
Open Flap DebridementProcedure or surgery
After local anesthesia, intra-sulcular incisions are done and a flap is released to access to the intra-bony defect.
Granulation tissue is removed and carefully laid aside for further analysis. Interrupted sutures are done to close the flap.
| Study group | Role | What they receive |
|---|---|---|
| Periimplantitis | patients formerly treated with a non surgical procedure without antibiotics with at least one functional dental implant with at least on pocket deeper than 5 mm with bleeding on probing and radiographical alveolar bone loss.
These patient will be treated by open flap debridement nd the granulation tissue xill be harvested for analysis. Receives: Procedure: Open Flap Debridement | |
| Periodontitis | patients formerly treated with a non surgical procedure without antibiotics for a generalized severe chronic periodontitis (in accord to Armitage 2009) and needing a resective surgical procedure (periodontal pockets deeper than 5 mm with bleeding on probing) These patient will be treated by open flap debridement nd the granulation tissue xill be harvested for analysis. Receives: Procedure: Open Flap Debridement | |
| Healthy patient | healthy patients needing crown lengthening allowing collection of gingival explants Receives: Procedure: Crown lengthening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukine 17 (IL-17) releasing from periodontitis and peri-implantitis gingival samples
Interleukine 17 (IL-17) releasing in the medium from harvested granulation tissue from periodontitis, peri-implantitis and healthy patients will be determine by ELISA test 24 hours after the beginning of the culture.
Measured: 24 hours of incubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study startApr 2014
- Primary completionApr 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 33 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Paris 5 - Rene Descartes
- Sponsor type
- University, hospital or other
- Collaborators
- Dentsply Sirona Implants and Consumables
- Responsible party
- Principal investigator, Marjolaine Gosset, University of Paris 5 - Rene Descartes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02664675
- Sponsor's protocol ID
- D-2013-003
- Acronym
- DUOROPA
- Status last verified
- Jan 2016
- First submitted
- 25 Apr 2014
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cytokines Production and Cellular Recruitment in Gingival Crevicular Fluid (GCF) and Granulation Tissue From Periodontitis, Peri-implantitis and Healthy Patients Leading to Activation of Osteoclasts and Bone Resorption
- ClinicalTrials.gov ID
- NCT02664675
- Acronym / sponsor ID
- DUOROPA / D-2013-003
- Conditions
- Peri-Implantitis, Periodontitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Paris 5 - Rene DescartesUniversity, hospital or other
- Collaborators
- Dentsply Sirona Implants and Consumables
- Study start
- Apr 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 27 Jan 2016 (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.
Recent data found that peri-implantitis may differ from periodontitis at the histological level in terms of extent and composition of the cellular components. From human biopsies, it has been shown a deeper apical extension of the inflammatory cell infiltrate and a larger proportion of granulocytes and macrophages in peri-implantitis lesions compared to periodontitis lesions. Following experimental peri-implantitis, it has been observed a continuing bone loss around dental implants after ligature removal; whereas, such a progression was not observed around teeth after cessation of the experimental periodontitis. The factors influencing the recruitment and the activation of osteoclasts in both diseases have not been compared yet.
Hypothesis : The more rapid and more severe alveolar bone destruction occurring in peri-implantitis compared to periodontitis is due at least in part to differences in the inflammatory process in these diseases.
Aim: to study the cytokine profile produced by gingival explants from periodontitis or peri-implantitis sites and to test the consequences on alteration of bone remodelling activity using in vitro approach.
Materials and methods The investigators will establish a collection of human gingival samples from patients undergoing surgical treatment of periodontitis or peri-implantitis. The investigators will test pro-inflammatory cytokines and chemokines release and consequences on osteoclast differentiation and activity.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Periimplantitis | – | Procedure: Open Flap Debridementpatients formerly treated with a non surgical procedure without antibiotics with at least one functional dental implant with at least on pocket deeper than 5 mm with bleeding on probing and radiographical alveolar bone loss. These patient will be treated by open flap debridement nd the granulation tissue xill be harvested for analysis. |
| Periodontitis | – | Procedure: Open Flap Debridementpatients formerly treated with a non surgical procedure without antibiotics for a generalized severe chronic periodontitis (in accord to Armitage 2009) and needing a resective surgical procedure (periodontal pockets deeper than 5 mm with bleeding on probing) These patient will be treated by open flap debridement nd the granulation tissue xill be harvested for analysis. |
| Healthy patient | – | Procedure: Crown lengtheninghealthy patients needing crown lengthening allowing collection of gingival explants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated in periodontology department of Hospital Rotschild or Charles Foix
Key inclusion criteria (10 listed)
- Beneficiary by national health insurance
- Age: over 18 year-old
- Non smoking
- Good health
- patients formerly treated with a non surgical procedure without antibiotics with at least one functional dental implant with at least on pocket deeper than 5 mm with bleeding on probing and radiographical alveolar bone loss.
Key exclusion criteria (5 listed)
- Smokers
- Patients treated with antibiotics or NSAID during the last 3 months
- Patients suffering from a chronic infectious, inflammatory or auto-immune disease (non equilibrated diabetes mellitus, rheumatoid arthritis, spondylarthrosis, Gougerot-Sjögren, Crohn, Behcet, Horton, obesity, chronic end renal disease, cardiopathies....)
- Pregnant women
- For the healthy group : bleeding on probing on the site.
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 |
|---|---|---|
| Crown lengtheningAfter a local anesthesia, gingival tissue is removed around the teeth to extend the length of the crown for aesthetic or prosthetic matter. | Procedure or surgery | Healthy patient |
| Open Flap DebridementAfter local anesthesia, intra-sulcular incisions are done and a flap is released to access to the intra-bony defect. Granulation tissue is removed and carefully laid aside for further analysis. Interrupted sutures are done to close the flap. | Procedure or surgery | Periimplantitis, Periodontitis |
Primary outcome
Interleukine 17 (IL-17) releasing from periodontitis and peri-implantitis gingival samples
Time frame: 24 hours of incubation
Interleukine 17 (IL-17) releasing in the medium from harvested granulation tissue from periodontitis, peri-implantitis and healthy patients will be determine by ELISA test 24 hours after the beginning of the culture.
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 28 Jan 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peri-Implantitis and Periodontitis, run by University of Paris 5 - Rene Descartes at 2 sites 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 10 inclusion and 5 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 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Interleukine 17 (IL-17) releasing from periodontitis and peri-implantitis gingival samples (time frame: 24 hours of incubation). 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 28 Jan 2016.