Cellular and Molecular Inflammatory Mechanisms Leading to Bone Resorption in Peri-implantitis Vs Periodontitis (DUOROPA)

January 27, 2016 updated by: Marjolaine Gosset, University of Paris 5 - Rene Descartes

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

33

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Ivry Sur Seine, France, 94200
        • Hospital Charles Foix APHP
      • Paris, France
        • Hospital Rotschild

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients treated in periodontology department of Hospital Rotschild or Charles Foix

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Procedure: Open Flap Debridement

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.
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.
Procedure: Open Flap Debridement

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.
Healthy patient
healthy patients needing crown lengthening allowing collection of gingival explants
Procedure: Crown lengthening
After a local anesthesia, gingival tissue is removed around the teeth to extend the length of the crown for aesthetic or prosthetic matter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours of incubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Paris 5 - Rene Descartes

Collaborators

Dentsply Sirona Implants and Consumables

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

April 25, 2014

First Submitted That Met QC Criteria

January 22, 2016

First Posted (Estimate)

January 27, 2016

Study Record Updates

Last Update Posted (Estimate)

January 28, 2016

Last Update Submitted That Met QC Criteria

January 27, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D-2013-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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