Back to resultsA NEW MECHANICAL DECONTAMINATION METHOD IN PERI-IMPLANTITIS, TI-BRUSH, A RANDOMIZED CONTROLLED CLINICAL TRIAL
Primary Purpose
Peri-Implantitis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Titanium brush
Classic decontamination
Sponsored by
About this trial
This is an interventional treatment trial for Peri-Implantitis focused on measuring regenera
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Titanium brush, H2O2 3%, plastic curettes
H2O2 3%, plastic curettes
Arm Description
Outcomes
Primary Outcome Measures
Evaluate probing pocket depth changes by decontamination of the implant surface with ultrasonics, 3% H2O2, and Ti-Brush™ at 6 and 12 months.
Secondary Outcome Measures
Full Information
NCT ID
NCT03512730
First Posted
April 27, 2018
Last Updated
May 1, 2018
Sponsor
Universitat Internacional de Catalunya
1. Study Identification
Unique Protocol Identification Number
NCT03512730
Brief Title
A NEW MECHANICAL DECONTAMINATION METHOD IN PERI-IMPLANTITIS, TI-BRUSH, A RANDOMIZED CONTROLLED 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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
November 19, 2013 (Actual)
Primary Completion Date
December 10, 2013 (Actual)
Study Completion Date
June 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitat Internacional de Catalunya
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-Implantitis
Keywords
regenera
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Titanium brush, H2O2 3%, plastic curettes
Arm Type
Experimental
Arm Title
H2O2 3%, plastic curettes
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Titanium brush
Intervention Description
a titanium brush will be tested as mechanical decontamination in regenerative treatment of peri-implantitis
Intervention Type
Other
Intervention Name(s)
Classic decontamination
Intervention Description
Classic decontamination will be performed by means of H2O2 3% and plastic curettes
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Eligibility 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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing 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.
Learn more about this trial
A NEW MECHANICAL DECONTAMINATION METHOD IN PERI-IMPLANTITIS, TI-BRUSH, A RANDOMIZED CONTROLLED CLINICAL TRIAL
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