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OpenTrials
Completed

NCT Number: NCT03620331

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Surgery with a previous non-surgical approach

Procedure

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

Surgery without a previous non-surgical approach

Procedure

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Collaborators

  • Azienda Policlinico Umberto I
  • Osteology Foundation
  • University of Turin, Italy

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 8, 2018
Registry last updated
May 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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