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

NCT03512730 | Completed Phase 2 DMC

• 1 other identifier: PERECL-201305
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Peri-Implantitis

Keywords

regenera

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Titanium brush, H2O2 3%, plastic curettes

EXPERIMENTAL

Device: Titanium brush; Other: Classic decontamination

H2O2 3%, plastic curettes

ACTIVE COMPARATOR

Other: Classic decontamination

Interventions

Titanium brush DEVICE

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

Titanium brush, H2O2 3%, plastic curettes

Classic decontamination OTHER

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

H2O2 3%, plastic curettes; Titanium brush, H2O2 3%, plastic curettes

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Related Publications (1)

• 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 Nov;96(11):1213-1226. doi: 10.1002/JPER.24-0673. Epub 2025 Mar 28.

  PMID: 40153369 DERIVED

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 27, 2018
• First Posted: May 1, 2018
• Study Start: November 19, 2013
• Primary Completion: December 10, 2013
• Study Completion: June 20, 2017
• Last Updated: May 4, 2018

Record last verified: 2018-05