Epstein-Barr Virus Implication in Peri-implantitis: Towards an Innovative Etiopathogenic Model.

NCT03631849 | Completed

• 1 other identifier: 18-AOI-10
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Peri-implantitis is a high prevalence disease that affects Dental Implants, and can lead to the implant loss if untreated. This condition isn't really well known, and treatments can't provide predictable results. The aim of this study will be to establish a link between the Epstein Barr Virus and the Peri-implantitis, as suggested by recent studies.

Conditions

Peri-Implantitis

Outcome Measures

Primary Outcomes (1)

• Correlate the Epstein-Barr Virus (EBV) levels of peri-implant sites with the presence of peri-implantitis

  The Epstein-Barr Virus (EBV) levels in periodontal sample is measured through quantitative Polymerase Chain Reaction (PCR) of their viral genomes, throughout patient follow-up.

  At inclusion, at surgery and 1, 6, 12 and 18 months post-surgery

Secondary Outcomes (6)

• Correlate cellular viral load to depth of peri-implant pocket

  At inclusion, at surgery and 1, 6, 12 and 18 months post-surgery

• Correlate cellular viral load to peri-implantite treatment failure (recurrence)

  At 1, 6, 12 and 18 months post-surgery

• Correlate cellular viral load to local inflammatory response during follow-up

  At inclusion, at surgery and 1, 6, 12 and 18 months post-surgery

• Correlate cellular viral load to the presence of virulent bacteria

  At 1, 6, 12 and 18 months post-surgery

• Characterize Epstein-Barr Virus (EBV)-infected cell types

  At 1, 6, 12 and 18 months post-surgery

Study Arms (2)

Patients with peri-implantitis

EXPERIMENTAL

Procedure: peri implantitis sanitation surgery

Patients without peri-implantitis

ACTIVE COMPARATOR

Other: Care

Interventions

Care OTHER

descaling and maintenance of implants

Patients without peri-implantitis

peri implantitis sanitation surgery PROCEDURE

an intrasulcular vestibular and lingual / palatal incision with respect to the implant-supported restoration involved is performed, it extends to at least one tooth on either side in order to give laxity to the flap. The use of an incision of discharge will be necessary if the muco-periosteal detachment of the flap (that is to say of full thickness) is considered insufficient to access and unclamp the peri-implant lesion. Then, the debridement will be carried out using manual curettes in titanium: the products (waste) removed with this curette will constitute the peri-implant pocket specimens. This sample will be deposited in a Roswell Park Memorial Institute Medium (RPMI) supplemented with serum.The surface of the titanium implant will then be disinfected with betadine, or with hydrogen peroxide for patients with an allergy to polyvidone iodine. The flap will then be repositioned and sutured with simple stitches made with a resorbable suture of Vicryl type 5.0.

Patients with peri-implantitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient
• Patient with at least one dental implant with a fixed implant-supported prostheses
• Patient with a peri-implantitis
• (Patient with healthy dental implant for control group)
• patients having read and understood the information note on the study and signed the informed consent form.
• patients affiliated to the social security system.

You may not qualify if:

• Patient with severe hematologic disease
• Patients with previous or current acute illness or severe chronic cardiovascular, renal, hepatic, gastrointestinal, allergic, endocrine, neuro-psychiatric, considered by the investigator to be incompatible with the conduct of the study.
• Patients treated with retinoids, oral bisphosphonates, oral anticoagulants or anticonvulsants.
• Patient have or have had cancer of the upper aerodigestive tract treated by radiotherapy.
• Patient taking a steroidal or non-steroidal anti-inflammatory, anti-cancer or immunosuppressive chemotherapy in the last 6 months.
• Patient monitoring considered difficult by the investigator.
• Patient with oral dermatitis or adverse occlusion.
• Patient with autoimmune disease
• Patient with a linguistic or mental incapacity to understand information
• Patient trust under curators or judicial protection
• Patient participating in another clinical study.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, France, 06000, France

Location

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 15, 2018
• Study Start: November 2, 2020
• Primary Completion: October 28, 2025
• Study Completion: October 28, 2025
• Last Updated: February 11, 2026

Record last verified: 2025-11

Locations

FR (1)