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

Primary Purpose

Peri-Implantitis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Surgery with a previous non-surgical approach
Surgery without a previous non-surgical approach
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-Implantitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Non Surgical + Surgical

Immediate Surgery

Arm Description

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

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

Outcomes

Primary Outcome Measures

Disease Resolution
Probing Pocket Depth changes
Measured from the mucosal margin to the bottom of the probeable pocket.

Secondary Outcome Measures

Full Information

First Posted
August 2, 2018
Last Updated
May 11, 2021
Sponsor
Universidad Complutense de Madrid
Collaborators
Azienda Policlinico Umberto I, University of Turin, Italy, Osteology Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03620331
Brief Title
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Complutense de Madrid
Collaborators
Azienda Policlinico Umberto I, University of Turin, Italy, Osteology Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-Implantitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non Surgical + Surgical
Arm Type
Active Comparator
Arm Description
Non surgical approach (NS) followed by surgical treatment (S) of peri-implantitis
Arm Title
Immediate Surgery
Arm Type
Experimental
Arm Description
Direct surgical approach (S), without a previous non surgical approach
Intervention Type
Procedure
Intervention Name(s)
Surgery with a previous non-surgical approach
Intervention Description
Non-surgical phase done prior to the surgical treatment of peri-implantitis
Intervention Type
Procedure
Intervention Name(s)
Surgery without a previous non-surgical approach
Intervention Description
Non-surgical phase not done prior to the surgical treatment of peri-implantitis
Primary Outcome Measure Information:
Title
Disease Resolution
Time Frame
1 year post-surgery
Title
Probing Pocket Depth changes
Description
Measured from the mucosal margin to the bottom of the probeable pocket.
Time Frame
1 year post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariano Sanz Alonso
Organizational Affiliation
Department of Periodontology, University Complutense Madrid, Spain
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Luca Cordaro
Organizational Affiliation
Department of Periodontology and Prosthodontics, "Umberto I" Policlinic - "G. Eastman" Section
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mario Romandini
Organizational Affiliation
Department of Periodontology, University Complutense Madrid, Spain
Official's Role
Study Director
Facility Information:
Facility Name
Policlinico Umberto I - "G. Eastman" Section - Department of Periodontology
City
Roma
Country
Italy
Facility Name
Department of Surgical Sciences, C.I.R. Dental School, University of Turin
City
Turin
Country
Italy
Facility Name
Department of Periodontology, University Complutense Madrid, Spain
City
Madrid
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
36085409
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.
Results Reference
derived

Learn more about this trial

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

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