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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2020-11-30

Brief Summary

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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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Detailed Description

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Conditions

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Peri-Implantitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Non Surgical + Surgical

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

Group Type ACTIVE_COMPARATOR

Surgery with a previous non-surgical approach

Intervention Type PROCEDURE

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

Immediate Surgery

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

Group Type EXPERIMENTAL

Surgery without a previous non-surgical approach

Intervention Type PROCEDURE

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

Interventions

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Surgery with a previous non-surgical approach

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

Intervention Type PROCEDURE

Surgery without a previous non-surgical approach

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

* 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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No