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

NCT ID: NCT02664675

Last Updated: 2016-01-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 33 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2016-01-31

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.

Conditions

Peri-Implantitis; Periodontitis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

Open Flap Debridement

Intervention Type: PROCEDURE

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.

Open Flap Debridement

Intervention Type: PROCEDURE

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

Crown lengthening

Intervention Type: PROCEDURE

After a local anesthesia, gingival tissue is removed around the teeth to extend the length of the crown for aesthetic or prosthetic matter.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dentsply Sirona Implants and Consumables

INDUSTRY

Sponsor Role: collaborator

University of Paris 5 - Rene Descartes

OTHER

Sponsor Role: lead

Responsible Party

Marjolaine Gosset

Associate professor in Periodontology, Faculty of dental surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Charles Foix APHP

Ivry-sur-Seine, , France

Hospital Rotschild

Paris, , France

Countries

France

Other Identifiers

D-2013-003

Identifier Type: -

Identifier Source: org_study_id