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

Overview

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.

Full Title of Study: “BENEFITS OF A NEW MECHANICAL DECONTAMINATION METHOD, TI-BRUSH, ON THE ADJUNCT TREATMENT OF REGENERATIVE THERAPY OF PERI-IMPLANTITIS LESIONS: 12-MONTH OUTCOMES OF A RANDOMIZED CONTROLLED CLINICAL TRIAL”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 10, 2013

Interventions

  • Device: Titanium brush
    • a titanium brush will be tested as mechanical decontamination in regenerative treatment of peri-implantitis
  • Other: Classic decontamination
    • Classic decontamination will be performed by means of H2O2 3% and plastic curettes

Arms, Groups and Cohorts

  • Experimental: Titanium brush, H2O2 3%, plastic curettes
  • Active Comparator: H2O2 3%, plastic curettes

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Investigator Details

  • Lead Sponsor
    • Universitat Internacional de Catalunya
  • Provider of Information About this Clinical Study
    • Principal Investigator: Beatriz de Tapia, Associate professor – Universitat Internacional de Catalunya

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