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

Study Overview
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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.

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

Conditions
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Peri-Implantitis

Intervention / Treatment
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* Procedure: Surgery with a previous non-surgical approach
* Procedure: Surgery without a previous non-surgical approach


Participation Criteria
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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: 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Non Surgical + Surgical<br>Non surgical approach (NS) followed by surgical treatment (S) of peri-implantitis | Procedure: Surgery with a previous non-surgical approach<br>* Non-surgical phase done prior to the surgical treatment of peri-implantitis<br>|
| Experimental: Immediate Surgery<br>Direct surgical approach (S), without a previous non surgical approach | Procedure: Surgery without a previous non-surgical approach<br>* Non-surgical phase not done prior to the surgical treatment of peri-implantitis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |