Cellular and Molecular Inflammatory Mechanisms Leading to Bone Resorption in Peri-implantitis Vs Periodontitis
DUOROPA
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
1 other identifier
observational
33
1 country
2
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2014
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 25, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedFirst Posted
Study publicly available on registry
January 27, 2016
CompletedJanuary 28, 2016
January 1, 2016
1 year
April 25, 2014
January 27, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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.
24 hours of incubation
Study Arms (3)
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.
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.
Healthy patient
healthy patients needing crown lengthening allowing collection of gingival explants
Interventions
After a local anesthesia, gingival tissue is removed around the teeth to extend the length of the crown for aesthetic or prosthetic matter.
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.
Eligibility Criteria
Patients treated in periodontology department of Hospital Rotschild or Charles Foix
You may qualify if:
- 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.
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hospital Charles Foix APHP
Ivry-sur-Seine, 94200, France
Hospital Rotschild
Paris, France
Biospecimen
Gingiva samples
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor in Periodontology, Faculty of dental surgery
Study Record Dates
First Submitted
April 25, 2014
First Posted
January 27, 2016
Study Start
April 1, 2014
Primary Completion
April 1, 2015
Study Completion
January 1, 2016
Last Updated
January 28, 2016
Record last verified: 2016-01