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NCT03512730

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

Completed Phase 2 Last updated 4 May 2018
What this trial tests

Phase 2 trial testing Titanium brush in Peri-Implantitis in 30 participants. Completed in 20 June 2017.

Timeline
19 November 2013
Primary endpoint
10 December 2013
20 June 2017

Quick facts

Lead sponsorUniversitat Internacional de Catalunya
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment30
Start date19 November 2013
Primary completion10 December 2013
Estimated completion20 June 2017

Drugs / interventions tested

Conditions studied

Sponsor

Universitat Internacional de Catalunya — full company profile →

Who can join

Adults 18 to 90, any sex, with Peri-Implantitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Peri-implantitis reconstructive treatment implementing a titanium brush: 5-year extension results from a randomized clinical trial.
    de Tapia B, Ribeiro-Amaral T, Mor C, Nart J, et al · · 2025 · cited 1× · PMID 40153369 · DOI 10.1002/jper.24-0673

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Other trials of Titanium brush

Trials testing the same drug.

Other recruiting trials for Peri-Implantitis

Currently open trials in the same condition.

Other Universitat Internacional de Catalunya trials

Trials by the same sponsor.

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Data sources for this page

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