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

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ClinicalTrials.gov Identifier: NCT03512730
Recruitment Status : Completed
First Posted : May 1, 2018
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
Beatriz de Tapia, Universitat Internacional de Catalunya

Study Description
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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.


Condition or disease Intervention/treatment Phase
Peri-Implantitis Device: Titanium brush Other: Classic decontamination Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 19, 2013
Actual Primary Completion Date : December 10, 2013
Actual Study Completion Date : June 20, 2017
Arms and Interventions
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Arm Intervention/treatment
Experimental: Titanium brush, H2O2 3%, plastic curettes 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
Active Comparator: H2O2 3%, plastic curettes Other: Classic decontamination
Classic decontamination will be performed by means of H2O2 3% and plastic curettes


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Beatriz de Tapia, Associate professor, Universitat Internacional de Catalunya
ClinicalTrials.gov Identifier: NCT03512730    
Other Study ID Numbers: PERECL-201305
First Posted: May 1, 2018    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The results obtained are expected to be published in both national and international journals. In addition, the results will be disseminated national and international scientific events.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Beatriz de Tapia, Universitat Internacional de Catalunya:
regenera
Additional relevant MeSH terms:
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Peri-Implantitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases