Furcation DefectsNCT02132806
Piezosurgery in the Treatment of Class II Furcation Involvement
A study testing Piezosurgery with biomaterial mp3 + bracket, Piezosurgery with biomaterial mp3 and Piezosurgery in people with Furcation Defects, run by Matteo Visintin at 1 site in Italy.
Trial summary
The purpose of this study is to evaluate the effectiveness of piezosurgery in the treatment of class II furcation involvement using biomaterials and new surgical techniques Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Furcation Defects
- What is being tested?
- Piezosurgery with biomaterial mp3 + bracket, Piezosurgery with biomaterial mp3 and Piezosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2014to Nov 2017
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- previous subgingival instrumentation with adequate plaque control (FMPS < 20%) and bleeding on probing (FMBS < 20%).
- one or more mandibular molar with buccal class-II furcation involvement
Who cannot join
- diabetes mellitus
- pregnancy and lactation period
- subjects smoking > 10 cigarettes/day were excluded
- subjects in chronically treatment with calcium antagonist, immunosuppressive drugs and Antiepileptic Drugs
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the effectiveness of piezosurgery in the treatment of class II furcation involvement using biomaterials and new surgical techniques
- Conditions
- Furcation Defects
- Being tested
- Piezosurgery with biomaterial mp3 + bracket, Piezosurgery with biomaterial mp3, Piezosurgery
- Keywords
- class II furcation involvement, piezoelectric surgery, regeneration, biomaterial
- Medical subject headings
- Furcation Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piezosurgery with biomaterial mp3 + bracketProcedure or surgery
Piezosurgery with biomaterial mp3Procedure or surgery
PiezosurgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| OFD with piezosurgery | Experimental | Open flap debridement with Piezosurgery Receives: Procedure: Piezosurgery |
| OFD with piezosurgery+biomaterial | Experimental | Open flap debridement with Piezosurgery with biomaterial mp3 Receives: Procedure: Piezosurgery with biomaterial mp3 |
| OFD with piezosurgery+mp3+bracket | Experimental | Open flap debridement with Piezosurgery with biomaterial mp3 + bracket Receives: Procedure: Piezosurgery with biomaterial mp3 + bracket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Horizontal probing depth (PH)
horizontal probing depth
Measured: 180 days
Secondary outcomes (5)
Plaque index (PI)
plaque index
Measured: 180 days
Bleeding on probing (BoP)
bleeding on probing
Measured: 180 days
Pocket probing depth (PPD)
pocket probing depth
Measured: 180 days
Furcation closure (FC)
furcation closure
Measured: 180 days
Clinical attachment level (CAL)
clinical attachment level
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2014 (estimated)
- Study startMar 2014
- Primary completionOct 2015
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Furcation DefectsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matteo Visintin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Matteo Visintin, University of Trieste
- Investigators
- Matteo Visintin, Principal investigator, UCO Clinica Odontoiatrica e Stomatologica - Ospedale Maggiore Trieste
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132806
- Sponsor's protocol ID
- UNITS01-2014
- Status last verified
- Feb 2017
- First submitted
- 5 May 2014
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piezosurgery in the Treatment of Class II Furcation Involvement
- ClinicalTrials.gov ID
- NCT02132806
- Acronym / sponsor ID
- UNITS01-2014
- Conditions
- Furcation Defects
- Keywords
- class II furcation involvement, piezoelectric surgery, regeneration, biomaterial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Matteo VisintinUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2017 (estimated)
- First posted
- 7 May 2014 (estimated)
- 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.
The purpose of this study is to evaluate the effectiveness of piezosurgery in the treatment of class II furcation involvement using biomaterials and new surgical techniques
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OFD with piezosurgery | Experimental | Procedure: PiezosurgeryOpen flap debridement with Piezosurgery |
| OFD with piezosurgery+biomaterial | Experimental | Procedure: Piezosurgery with biomaterial mp3Open flap debridement with Piezosurgery with biomaterial mp3 |
| OFD with piezosurgery+mp3+bracket | Experimental | Procedure: Piezosurgery with biomaterial mp3 + bracketOpen flap debridement with Piezosurgery with biomaterial mp3 + bracket |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- previous subgingival instrumentation with adequate plaque control (FMPS < 20%) and bleeding on probing (FMBS < 20%).
- one or more mandibular molar with buccal class-II furcation involvement
Key exclusion criteria (4 listed)
- diabetes mellitus
- pregnancy and lactation period
- subjects smoking > 10 cigarettes/day were excluded
- subjects in chronically treatment with calcium antagonist, immunosuppressive drugs and Antiepileptic Drugs
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 |
|---|---|---|
| Piezosurgery with biomaterial mp3 + bracket | Procedure or surgery | OFD with piezosurgery+mp3+bracket |
| Piezosurgery with biomaterial mp3 | Procedure or surgery | OFD with piezosurgery+biomaterial |
| Piezosurgery | Procedure or surgery | OFD with piezosurgery |
Primary outcome
Horizontal probing depth (PH)
Time frame: 180 days
horizontal probing depth
5 secondary outcomes
Plaque index (PI)
Time frame: 180 days
Bleeding on probing (BoP)
Time frame: 180 days
Pocket probing depth (PPD)
Time frame: 180 days
Furcation closure (FC)
Time frame: 180 days
Clinical attachment level (CAL)
Time frame: 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
Related trials for Furcation Defects
RecruitingPhase 3
Treatment of Class II Mandibular Furcation Defects
Class II Furcation Defect
Recruiting
Injectable Platelet-Rich Fibrin With Minimally Invasive Non-Surgical Technique in Treatment of Grade II Furcation Defects
Injectable Platelet-Rich Fibrin, Minimally Invasive
Recruiting
Enamel Matrix Derivative and Xenograft for Mandibular Molar Furcation Defects
Class II Furcation Defect
Recruiting
Morphological Characteristics of Mandibular Molar Furcation Involvement and Efficacy of Regenerative Surgical Treatment
Periodontitis, Periodontitis (Stage 3)
Recruiting
Efficacy of PRF and Xenograft in Treating Mandibular Molar Furcation Involvements
Periodontitis, Furcation Defects
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.
Matteo Visintin principal investigator
UCO Clinica Odontoiatrica e Stomatologica - Ospedale Maggiore Trieste
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Piezosurgery with biomaterial mp3 + bracket, Piezosurgery with biomaterial mp3 and Piezosurgery in people with Furcation Defects, run by Matteo Visintin at 1 site in Italy.
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 2 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: status not confirmed, as of the sponsor's last update on 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Results are not available in the source record.
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?
Horizontal probing depth (PH) (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2017.