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

Peri-Implantitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03620331
• Other study ID #: Peri-implantitis_ImmediateSurg
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: November 30, 2020

Study information

• Verified date: May 2021
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Peri-Implantitis

Intervention

Procedure:
• Surgery with a previous non-surgical approach
Non-surgical phase done prior to the surgical treatment of peri-implantitis
• Surgery without a previous non-surgical approach
Non-surgical phase not done prior to the surgical treatment of peri-implantitis

Locations

Country	Name	City	State
Italy	Policlinico Umberto I - "G. Eastman" Section - Department of Periodontology	Roma
Italy	Department of Surgical Sciences, C.I.R. Dental School, University of Turin	Turin
Spain	Department of Periodontology, University Complutense Madrid, Spain	Madrid

Sponsors (4)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid	Azienda Policlinico Umberto I, Osteology Foundation, University of Turin, Italy

Countries where clinical trial is conducted

Italy,  Spain, 

Outcome

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