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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 30
- Primary Endpoint
- Evaluate probing pocket depth changes by decontamination of the implant surface with ultrasonics, 3% H2O2, and Ti-Brush™ at 6 and 12 months.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Titanium brush, H2O2 3%, plastic curettes
Intervention: Titanium brush (Device)
Titanium brush, H2O2 3%, plastic curettes
Intervention: Classic decontamination (Other)
H2O2 3%, plastic curettes
Intervention: Classic decontamination (Other)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Beatriz de Tapia
Associate professor
Universitat Internacional de Catalunya