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

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.

Official Title
-----------------
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

Conditions
-----------------
Peri-Implantitis

Intervention / Treatment
-----------------
* Device: Titanium brush
* Other: Classic decontamination


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Titanium brush, H2O2 3%, plastic curettes<br> | Device: Titanium brush<br>* a titanium brush will be tested as mechanical decontamination in regenerative treatment of peri-implantitis<br>Other: Classic decontamination<br>* Classic decontamination will be performed by means of H2O2 3% and plastic curettes<br>|
| Active Comparator: H2O2 3%, plastic curettes<br> | Other: Classic decontamination<br>* Classic decontamination will be performed by means of H2O2 3% and plastic curettes<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
regenera