Surgical Treatment of Peri-implantitis With and Without an Initial Non-surgical Approach: a Multi-center Randomized Clinical Trial

Universidad Complutense de Madrid3 sites in 2 countries42 target enrollmentJuly 1, 2018

ConditionsPeri-Implantitis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Peri-Implantitis
Sponsor: Universidad Complutense de Madrid
Enrollment: 42
Locations: 3
Primary Endpoint: Disease Resolution
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Randomized, surgeon and outcome assessor blinded, multi-centric, superiority trial with two parallel groups and a 1:1 allocation ratio with the aim of comparing the surgical treatment of severe peri-implantitis with or without an initial non surgical approach.

Registry

clinicaltrials.gov

Start Date

July 1, 2018

End Date

November 30, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Universidad Complutense de Madrid

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Any patient having at least one implant affected by severe peri-implantitis, being at least 18 years old and able to sign an informed consent form will be potentially eligible for this trial.
•Severe peri-implantitis will be defined as peri-implant probing pocket depth \[PPD\] ≥6 mm in at least 1 site of the implant, together with bleeding and/or suppuration on probing \[BoP and/or SoP, respectively\] and radiographically documented marginal bone loss/level ≥3 mm (Carcuac et al. 2016) on implants in function by at least 1 year. In case of absence of baseline radiographs, the reference point for baseline bone levels will be considered where bone was likely to be at implant placement.

Exclusion Criteria

•Patients fitting to all the inclusion criteria as above will be not included in the study if they appear to be unable to attend to the study-related procedures (including the follow-up visits) or if one or more of the following systemic or local exclusion criteria are found in the enrolment phase.
•Systemic primary exclusion criteria:
•compromised general health which contraindicates the study procedures (ASA IV-VI patients);
•systemic diseases which could influence the outcome of the therapy (uncontrolled diabetes mellitus);
•pregnant or nursing women;
•chronic use of corticosteroids or NSAID or immune-modulator drugs (any type and any dose);
•patients who need use of medications affecting bone metabolism or peri-implant mucosa (bisphosphonates, any type and any dose).
•Local primary exclusion criteria:
•history of peri-implantitis treatment on implants to be included in the study (included topical antibiotics);
•hopeless implants (e.g. mobility) to be included in the study.