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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03620331

Enrollment

Registered

2018-08-08

Start date

2018-07-01

Completion date

2020-11-30

Last updated

2021-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peri-Implantitis

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.

Interventions

PROCEDURESurgery with a previous non-surgical approach

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

PROCEDURESurgery without a previous non-surgical approach

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Disease Resolution	1 year post-surgery	—
Probing Pocket Depth changes	1 year post-surgery	Measured from the mucosal margin to the bottom of the probeable pocket.

Countries

Italy, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026