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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-19

Study Completion Date

2017-06-20

Brief Summary

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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.

Detailed Description

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Conditions

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Peri-Implantitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Titanium brush, H2O2 3%, plastic curettes

Group Type EXPERIMENTAL

Titanium brush

Intervention Type DEVICE

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

Classic decontamination

Intervention Type OTHER

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

H2O2 3%, plastic curettes

Group Type ACTIVE_COMPARATOR

Classic decontamination

Intervention Type OTHER

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

Intervention Type DEVICE

Classic decontamination

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitat Internacional de Catalunya

OTHER

Sponsor Role lead

Responsible Party

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Beatriz de Tapia

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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.

Reference Type DERIVED
PMID: 40153369 (View on PubMed)

Other Identifiers

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PERECL-201305

Identifier Type: -

Identifier Source: org_study_id

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