CClinicalTrials.gg
CompletedNCT03620331Updated May 14, 2021

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

An interventional study of Surgery with a previous non-surgical approach and Surgery without a previous non-surgical approach in Peri-Implantitis, sponsored by Universidad Complutense de Madrid. Completed at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-14.

Sponsored by Universidad Complutense de Madrid · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Peri-Implantitis

Browse trials for

03

In context

Peri-Implantitis

304 studies on the registry are indexed under Peri-Implantitis; 84 are open to participants now.

This study's enrollment of 42 is close to the median of 40 across 182 interventional studies indexed under Peri-Implantitis.

Browse Peri-Implantitis studies →

Lead sponsor

Universidad Complutense de Madrid is the lead sponsor of 200 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
42 participants (actual)

Study arms

  • Active comparator
    Non Surgical + Surgical

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

    Procedure: Surgery with a previous non-surgical approach

  • Experimental
    Immediate Surgery

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

    Procedure: Surgery without a previous 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

06

What researchers measure

Primary outcomes

  1. Disease Resolution

    Time frame: 1 year post-surgery

  2. Probing Pocket Depth changes

    Measured from the mucosal margin to the bottom of the probeable pocket.

    Time frame: 1 year post-surgery

07

Study locations

3 sites
  • Policlinico Umberto I - "G. Eastman" Section - Department of Periodontology
    Roma, Italy
  • Department of Surgical Sciences, C.I.R. Dental School, University of Turin
    Turin, Italy
  • Department of Periodontology, University Complutense Madrid, Spain
    Madrid, Spain
08

References and documents

Publications

  • Romandini M, Lafori A, Pedrinaci I, Baima G, Ferrarotti F, Lima C, Paterno Holtzman L, Aimetti M, Cordaro L, Sanz M. Effect of sub-marginal instrumentation before surgical treatment of peri-implantitis: A multi-centre randomized clinical trial. J Clin Periodontol. 2022 Dec;49(12):1334-1345. doi: 10.1111/jcpe.13713. Epub 2022 Sep 9. PubMed 36085409 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03620331
Lead sponsor
Universidad Complutense de Madrid
Collaborators
Azienda Policlinico Umberto I, University of Turin, Italy, Osteology Foundation
Responsible party
Sponsor
First posted
Aug 8, 2018
Start date
Jul 1, 2018
Primary completion
Nov 30, 2020
Completion
Nov 30, 2020
Last update
May 14, 2021

Study contacts

Mariano Sanz Alonso
study chair · Department of Periodontology, University Complutense Madrid, Spain
Luca Cordaro
study chair · Department of Periodontology and Prosthodontics, "Umberto I" Policlinic - "G. Eastman" Section
Mario Romandini
study director · Department of Periodontology, University Complutense Madrid, Spain

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion