A NEW MECHANICAL DECONTAMINATION METHOD IN PERI-IMPLANTITIS, TI-BRUSH, A RANDOMIZED CONTROLLED CLINICAL TRIAL
NCT ID: NCT03512730
Last Updated: 2018-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2013-11-19
2017-06-20
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Titanium brush, H2O2 3%, plastic curettes
Titanium brush
a titanium brush will be tested as mechanical decontamination in regenerative treatment of peri-implantitis
Classic decontamination
Classic decontamination will be performed by means of H2O2 3% and plastic curettes
H2O2 3%, plastic curettes
Classic decontamination
Classic decontamination will be performed by means of H2O2 3% and plastic curettes
Interventions
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Titanium brush
a titanium brush will be tested as mechanical decontamination in regenerative treatment of peri-implantitis
Classic decontamination
Classic decontamination will be performed by means of H2O2 3% and plastic curettes
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
90 Years
ALL
No
Sponsors
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Universitat Internacional de Catalunya
OTHER
Responsible Party
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Beatriz de Tapia
Associate professor
References
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de Tapia B, Ribeiro-Amaral T, Mor C, Nart J, Valles C. Peri-implantitis reconstructive treatment implementing a titanium brush: 5-year extension results from a randomized clinical trial. J Periodontol. 2025 Mar 28. doi: 10.1002/JPER.24-0673. Online ahead of print.
Other Identifiers
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PERECL-201305
Identifier Type: -
Identifier Source: org_study_id
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