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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03512730

Enrollment

Registered

2018-05-01

Start date

2013-11-19

Completion date

2017-06-20

Last updated

2018-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peri-Implantitis

Keywords

regenera

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.

Interventions

DEVICETitanium brush

a titanium brush will be tested as mechanical decontamination in regenerative treatment of peri-implantitis

OTHERClassic decontamination

Classic decontamination will be performed by means of H2O2 3% and plastic curettes

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026