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

Periodontitis Clinical Trial

— DUOROPA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02664675
• Other study ID #: D-2013-003
• Status: Completed
• Phase: N/A
• First received: April 25, 2014
• Last updated: January 27, 2016
• Start date: April 2014
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: University of Paris 5 - Rene Descartes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational [Patient Registry]

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: January 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Bone Resorption
• Peri-Implantitis
• Periodontitis

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Hospital Charles Foix APHP	Ivry Sur Seine
France	Hospital Rotschild	Paris

Sponsors (2)

Lead Sponsor	Collaborator
University of Paris 5 - Rene Descartes	Dentsply Implants

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No