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

Universidad Complutense de Madrid

Status: Completed

Conditions: Peri-Implantitis

Treatments: Procedure: Surgery with a previous non-surgical approach; Procedure: Surgery without a previous non-surgical approach

Study type: Interventional

Funder types: Other

Identifiers

NCT03620331

Peri-implantitis_ImmediateSurg

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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42 participants in 2 patient groups

Non Surgical + Surgical

Active Comparator group

Description:

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

Treatment:

Procedure: Surgery with a previous non-surgical approach

Immediate Surgery

Experimental group

Description:

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

Treatment:

Procedure: Surgery without a previous non-surgical approach