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

Phase 2

Completed

• Conditions: Peri-Implantitis
• Interventions: Device: Titanium brush; Other: Classic decontamination

• Registration Number: NCT03512730
• Lead Sponsor: Universitat Internacional de Catalunya

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-19
• Primary Completion: 2013-12-10
• Study Completion: 2017-06-20
• Study First Submitted: 2018-04-27
• Study First Submitted QC: 2018-04-30
• Status Verified: 2018-05
• Study First Posted: 2018-05-01
• Last Update Submitted: 2018-05-01
• Last Update Posted: 2018-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Titanium brush, H2O2 3%, plastic curettes	Titanium brush	-
H2O2 3%, plastic curettes	Classic decontamination	-
Titanium brush, H2O2 3%, plastic curettes	Classic decontamination	-

Primary Outcome Measures

Name	Time	Method
Evaluate probing pocket depth changes by decontamination of the implant surface with ultrasonics, 3% H2O2, and Ti-Brush™ at 6 and 12 months.	6 and 12 months