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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03620331
Recruitment Status : Completed
First Posted : August 8, 2018
Last Update Posted : May 14, 2021
Sponsor:
Collaborators:
Azienda Policlinico Umberto I
University of Turin, Italy
Osteology Foundation
Information provided by (Responsible Party):
Universidad Complutense de Madrid

Study Description
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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.

Condition or disease Intervention/treatment Phase
Peri-Implantitis Procedure: Surgery with a previous non-surgical approach Procedure: Surgery without a previous non-surgical approach Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Surgical Treatment of Peri-implantitis With and Without an Initial Non-surgical Approach: a Multi-center Randomized Clinical Trial
Actual Study Start Date : July 1, 2018
Actual Primary Completion Date : November 30, 2020
Actual Study Completion Date : November 30, 2020
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Disease Resolution [ Time Frame: 1 year post-surgery ]
  2. Probing Pocket Depth changes [ Time Frame: 1 year post-surgery ]
    Measured from the mucosal margin to the bottom of the probeable pocket.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03620331


Locations
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Italy
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
Spain
Department of Periodontology, University Complutense Madrid, Spain
Madrid, Spain
Sponsors and Collaborators
Universidad Complutense de Madrid
Azienda Policlinico Umberto I
University of Turin, Italy
Osteology Foundation
Investigators
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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
More Information
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Responsible Party: Universidad Complutense de Madrid
ClinicalTrials.gov Identifier: NCT03620331    
Other Study ID Numbers: Peri-implantitis_ImmediateSurg
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: May 14, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peri-Implantitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases