A NEW MECHANICAL DECONTAMINATION METHOD IN PERI-IMPLANTITIS, TI-BRUSH, A RANDOMIZED CONTROLLED CLINICAL TRIAL

Universitat Internacional de Catalunya

Status and phase

Completed

Phase 2

Conditions

Peri-Implantitis

Treatments

Other: Classic decontamination

Device: Titanium brush

Study type

Interventional

Funder types

Other

Identifiers

NCT03512730

PERECL-201305

Details and patient eligibility

About

Objective:

The objective of this study was to evaluate a new mechanical method (Ti-Brush, Straumann, AG, Basel, Switzerland) of implant surface decontamination.

Material and methods:

A randomized double-blinded controlled clinical trial with a 1-year follow-up it is being carried out. After a hygienic phase, defects were randomly assigned to a control (n=18) or to a test group (n=18). In control group, implant surface was decontaminated both mechanically and chemically with 3% H2O2 and plastic ultrasonic scalers, respectively, while in test group Ti-Brush was added. Infrabony defects in both groups were regenerated with BoneCeramic (Straumann, AG, Basel Switzerland) and collagen barrier membrane Cytoplast (Osteogenics, Lubbock, United States). Clinical and radiographic parameters were measured at baseline, 6, and 12 months after surgery.

Enrollment

30 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Healthy or treated periodontal patients
A good level of oral hygiene (Plaque Index ≤ 25%) (O'Leary et al., 1972).
Presence of at least one titanium implant exhibiting peri-implantitis (peri-implant bone loss > 30% and Implant PPD ≥ 6 mm with bleeding and/or pus suppuration on probing)
Osseous defect had to be circumferential, or present at least two walls and 3mm depth.
Presence of >1 mm of keratinized peri-implant mucosa
Absence of systemic diseases that could influence the outcome of the therapy.

Exclusion criteria

Pregnant or lactating women
Esthetically compromised patients
Patients who received systemic antibiotics in the past 3 months or treatment of peri-implantitis in the last 12 months.
Smokers of more than 10 cigarettes a day