Surgical Treatment of Peri-implantitis With and Without an Initial Non-surgical Approach

Not Applicable

Completed

• Conditions: Peri-Implantitis
• Interventions: Procedure: Surgery with a previous non-surgical approach; Procedure: Surgery without a previous non-surgical approach

• Registration Number: NCT03620331
• Lead Sponsor: Universidad Complutense de Madrid

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-01
• Study First Submitted: 2018-08-02
• Study First Submitted QC: 2018-08-02
• Study First Posted: 2018-08-08
• Primary Completion: 2020-11-30
• Study Completion: 2020-11-30
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-11
• Last Update Posted: 2021-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non Surgical + Surgical	Surgery with a previous non-surgical approach	Non surgical approach (NS) followed by surgical treatment (S) of peri-implantitis
Immediate Surgery	Surgery without a previous non-surgical approach	Direct surgical approach (S), without a previous non surgical approach

Primary Outcome Measures

Name	Time	Method
Disease Resolution	1 year post-surgery
Probing Pocket Depth changes	1 year post-surgery	Measured from the mucosal margin to the bottom of the probeable pocket.

Trial Locations

Locations (3)

Policlinico Umberto I - "G. Eastman" Section - Department of Periodontology; 🇮🇹 Roma, Italy

Department of Surgical Sciences, C.I.R. Dental School, University of Turin; 🇮🇹 Turin, Italy

Department of Periodontology, University Complutense Madrid, Spain; 🇪🇸 Madrid, Spain