Peri-ImplantitisPhase 2NCT03512730
A NEW MECHANICAL DECONTAMINATION METHOD IN PERI-IMPLANTITIS, TI-BRUSH, A RANDOMIZED CONTROLLED CLINICAL TRIAL
A Phase 2 study testing Titanium brush and Classic decontamination in people with Peri-Implantitis, run by Universitat Internacional de Catalunya.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- Titanium brush and Classic decontamination
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 19 Nov 2013to 20 Jun 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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
Objective:
The objective of this study was to evaluate a new mechanical method (Ti-Brush, Straumann, AG, Basel, Switzerland) of implant surface decontamination.
Read more
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
- Being tested
- Titanium brush, Classic decontamination
- Keywords
- regenera
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titanium brushDevice
a titanium brush will be tested as mechanical decontamination in regenerative treatment of peri-implantitis
Classic decontaminationOther
Classic decontamination will be performed by means of H2O2 3% and plastic curettes
| Study group | Role | What they receive |
|---|---|---|
| Titanium brush, H2O2 3%, plastic curettes | Experimental | Not described Receives: Device: Titanium brush; Other: Classic decontamination |
| H2O2 3%, plastic curettes | Active comparator | Not described Receives: Other: Classic decontamination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate probing pocket depth changes by decontamination of the implant surface with ultrasonics, 3% H2O2, and Ti-Brush™ at 6 and 12 months.
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start19 Nov 2013
- Primary completion10 Dec 2013
- Study completion20 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beatriz de Tapia, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03512730
- Sponsor's protocol ID
- PERECL-201305
- Status last verified
- May 2018
- First submitted
- 27 Apr 2018
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
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.
PubMed 40153369
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03512730
- Acronym / sponsor ID
- PERECL-201305
- Conditions
- Peri-Implantitis
- Keywords
- regenera
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 19 Nov 2013 (actual)
- Primary completion
- 10 Dec 2013 (actual)
- Study completion
- 20 Jun 2017 (actual)
- First posted
- 1 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Titanium brush, H2O2 3%, plastic curettes | Experimental | Device: Titanium brush, Other: Classic decontamination |
| H2O2 3%, plastic curettes | Active comparator | Other: Classic decontamination |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Titanium brusha titanium brush will be tested as mechanical decontamination in regenerative treatment of peri-implantitis | Device | Titanium brush, H2O2 3%, plastic curettes |
| Classic decontaminationClassic decontamination will be performed by means of H2O2 3% and plastic curettes | Other | H2O2 3%, plastic curettes, Titanium brush, H2O2 3%, plastic curettes |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
- Derived from this study: PubMed 40153369de 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.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Titanium brush and Classic decontamination in people with Peri-Implantitis, run by Universitat Internacional de Catalunya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03512730, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2018.