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

Peri-Implantitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03512730
• Other study ID #: PERECL-201305
• Status: Completed
• Phase: Phase 2
• Start date: November 19, 2013
• Est. completion date: June 20, 2017

Study information

• Verified date: May 2018
• Source: Universitat Internacional de Catalunya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 20, 2017
• Est. primary completion date: December 10, 2013
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Peri-Implantitis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universitat Internacional de Catalunya

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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