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

May 1, 2018 updated by: Beatriz de Tapia, Universitat Internacional de Catalunya

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: 6 and 12 months
6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitat Internacional de Catalunya

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2013

Primary Completion (Actual)

December 10, 2013

Study Completion (Actual)

June 20, 2017

Study Registration Dates

First Submitted

April 27, 2018

First Submitted That Met QC Criteria

April 30, 2018

First Posted (Actual)

May 1, 2018

Study Record Updates

Last Update Posted (Actual)

May 4, 2018

Last Update Submitted That Met QC Criteria

May 1, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PERECL-201305

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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