ClinicalTrials.gg
Status unknownNCT02132806Updated Feb 10, 2017

Piezosurgery in the Treatment of Class II Furcation Involvement

An interventional study of Piezosurgery with biomaterial mp3 + bracket and Piezosurgery with biomaterial mp3 in Furcation Defects, sponsored by Matteo Visintin. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-10.

Sponsored by Matteo Visintin · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2017), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Furcation Defects

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Keywords

  • class II furcation involvement
  • piezoelectric surgery
  • regeneration
  • biomaterial
03

In context

Furcation Defects

42 studies on the registry are indexed under Furcation Defects; 13 are open to participants now.

This study's enrollment of 30 is above the median of 27 across 38 interventional studies indexed under Furcation Defects.

Browse Furcation Defects studies →

Lead sponsor

This is the only study on the registry with Matteo Visintin as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • diabetes mellitus
  • pregnancy and lactation period
  • subjects smoking > 10 cigarettes/day were excluded
  • subjects in chronically treatment with calcium antagonist, drugs and Antiepileptic Drugs
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    OFD with piezosurgery

    Open flap debridement with Piezosurgery

    Procedure: Piezosurgery

  • Experimental
    OFD with piezosurgery+biomaterial

    Open flap debridement with Piezosurgery with biomaterial mp3

    Procedure: Piezosurgery with biomaterial mp3

  • Experimental
    OFD with piezosurgery+mp3+bracket

    Open flap debridement with Piezosurgery with biomaterial mp3 + bracket

    Procedure: Piezosurgery with biomaterial mp3 + bracket

Interventions

  • ProcedurePiezosurgery with biomaterial mp3 + bracket
  • ProcedurePiezosurgery with biomaterial mp3
  • ProcedurePiezosurgery
06

What researchers measure

Primary outcomes

  1. Horizontal probing depth (PH)

    horizontal probing depth

    Time frame: 180 days

Secondary outcomes

  1. Plaque index (PI)

    plaque index

    Time frame: 180 days

  2. Bleeding on probing (BoP)

    bleeding on probing

    Time frame: 180 days

  3. Pocket probing depth (PPD)

    pocket probing depth

    Time frame: 180 days

  4. Furcation closure (FC)

    furcation closure

    Time frame: 180 days

  5. Clinical attachment level (CAL)

    clinical attachment level

    Time frame: 180 days

07

Study locations

1 site
  • Matteo Visintin
    Trieste, TS 34100, Italy
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2014, a primary completion of Oct 2015 and a completion of Nov 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 5, 2014
First posted
May 7, 2014
Start
Mar 2014
Primary completionActual
Oct 2015
CompletionEst.
Nov 2017
Last update
Feb 10, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 10, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02132806
Lead sponsor
Matteo Visintin
Responsible party
Matteo Visintin (Student, University of Trieste) — Sponsor-investigator
First posted
May 7, 2014
Start date
Mar 2014
Primary completion
Oct 2015
Completion
Nov 2017 (estimated)
Last update
Feb 10, 2017

Study contacts

Matteo Visintin
principal investigator · UCO Clinica Odontoiatrica e Stomatologica - Ospedale Maggiore Trieste

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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