Clinical trial NCT03620331: Surgical Treatment of Peri-implantitis With and Without an Initial Non-surgical Approach
Official title: Surgical Treatment of Peri-implantitis With and Without an Initial Non-surgical Approach: a Multi-center Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peri-Implantitis
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
Collaborators: name: Azienda Policlinico Umberto I
name: University of Turin, Italy
name: Osteology Foundation
First posted: 2018-08-08
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Secondary exclusion criteria:

- uncompliant patients (poor oral hygiene 2 weeks after OHI).

Primary outcomes:
measure: Disease Resolution
timeFrame: 1 year post-surgery
measure: Probing Pocket Depth changes
timeFrame: 1 year post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Policlinico Umberto I - "G. Eastman" Section - Department of Periodontology
city: Turin
country: Italy
facility: Department of Surgical Sciences, C.I.R. Dental School, University of Turin
city: Madrid
country: Spain
facility: Department of Periodontology, University Complutense Madrid, Spain
Study officials:
affiliation: Department of Periodontology, University Complutense Madrid, Spain
name: Mariano Sanz Alonso
role: STUDY_CHAIR
affiliation: Department of Periodontology and Prosthodontics, "Umberto I" Policlinic - "G. Eastman" Section
name: Luca Cordaro
role: STUDY_CHAIR
affiliation: Department of Periodontology, University Complutense Madrid, Spain
name: Mario Romandini
role: STUDY_DIRECTOR
References:
citation: Romandini M, Lafori A, Pedrinaci I, Baima G, Ferrarotti F, Lima C, Paterno Holtzman L, Aimetti M, Cordaro L, Sanz M. Effect of sub-marginal instrumentation before surgical treatment of peri-implantitis: A multi-centre randomized clinical trial. J Clin Periodontol. 2022 Dec;49(12):1334-1345. doi: 10.1111/jcpe.13713. Epub 2022 Sep 9.