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

NCT03620331 | Completed

• 1 other identifier: Peri-implantitis_ImmediateSurg
• Study Type: interventional
• Target: 42
• Locations: 2 countries
• Sites: 3

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.

Conditions

Peri-Implantitis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Non Surgical + Surgical

ACTIVE COMPARATOR

Non surgical approach (NS) followed by surgical treatment (S) of peri-implantitis

Procedure: Surgery with a previous non-surgical approach

Immediate Surgery

EXPERIMENTAL

Direct surgical approach (S), without a previous non surgical approach

Procedure: Surgery without a previous non-surgical approach

Interventions

Surgery with a previous non-surgical approach PROCEDURE

Non-surgical phase done prior to the surgical treatment of peri-implantitis

Non Surgical + Surgical

Surgery without a previous non-surgical approach PROCEDURE

Non-surgical phase not done prior to the surgical treatment of peri-implantitis

Immediate Surgery

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead
• Azienda Policlinico Umberto I: collaborator
• University of Turin, Italy: collaborator
• Osteology Foundation: collaborator

Study Sites (3)

Policlinico Umberto I - "G. Eastman" Section - Department of Periodontology

Roma, Italy

Location

Department of Surgical Sciences, C.I.R. Dental School, University of Turin

Turin, Italy

Location

Department of Periodontology, University Complutense Madrid, Spain

Madrid, Spain

Location

Related Publications (1)

• 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.

  PMID: 36085409 DERIVED

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• 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 CHAIR

• Mario Romandini

  Department of Periodontology, University Complutense Madrid, Spain

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: August 8, 2018
• Study Start: July 1, 2018
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: May 14, 2021

Record last verified: 2021-05

Locations

IT (2); ES (1)