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

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

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.

Study Overview

• Status: Completed
• Conditions: Peri-Implantitis
• Intervention / Treatment: Procedure: Surgery with a previous non-surgical approach; Procedure: Surgery without a previous non-surgical approach

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy
    • Policlinico Umberto I - "G. Eastman" Section - Department of Periodontology
  • Turin, Italy
    • Department of Surgical Sciences, C.I.R. Dental School, University of Turin
• Spain
  • Madrid, Spain
    • Department of Periodontology, University Complutense Madrid, Spain

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Non Surgical + Surgical; Non surgical approach (NS) followed by surgical treatment (S) of peri-implantitis	Procedure: Surgery with a previous non-surgical approach; Non-surgical phase done prior to the surgical treatment of peri-implantitis
Experimental: Immediate Surgery; Direct surgical approach (S), without a previous non surgical approach	Procedure: Surgery without a previous non-surgical approach; Non-surgical phase not done prior to the surgical treatment of peri-implantitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Resolution		1 year post-surgery
Probing Pocket Depth changes	Measured from the mucosal margin to the bottom of the probeable pocket.	1 year post-surgery

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid
• Collaborators: University of Turin, Italy; Osteology Foundation; Azienda Policlinico Umberto I
• Investigators: Study Chair: Mariano Sanz Alonso, Department of Periodontology, University Complutense Madrid, Spain; Study Chair: Luca Cordaro, Department of Periodontology and Prosthodontics, "Umberto I" Policlinic - "G. Eastman" Section; Study Director: Mario Romandini, Department of Periodontology, University Complutense Madrid, Spain

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: August 2, 2018
• First Submitted That Met QC Criteria: August 2, 2018
• First Posted (Actual): August 8, 2018

Study Record Updates

• Last Update Posted (Actual): May 14, 2021
• Last Update Submitted That Met QC Criteria: May 11, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Peri-Implantitis
• Other Study ID Numbers: Peri-implantitis_ImmediateSurg

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No