Piezosurgery in the Treatment of Class II Furcation Involvement

February 9, 2017 updated by: Matteo Visintin
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • TS
      • Trieste, TS, Italy, 34100
        • Matteo Visintin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Horizontal probing depth (PH)
Time Frame: 180 days
horizontal probing depth
180 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque index (PI)
Time Frame: 180 days
plaque index
180 days
Bleeding on probing (BoP)
Time Frame: 180 days
bleeding on probing
180 days
Pocket probing depth (PPD)
Time Frame: 180 days
pocket probing depth
180 days
Furcation closure (FC)
Time Frame: 180 days
furcation closure
180 days
Clinical attachment level (CAL)
Time Frame: 180 days
clinical attachment level
180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Matteo Visintin

Investigators

  • Principal Investigator: Matteo Visintin, UCO Clinica Odontoiatrica e Stomatologica - Ospedale Maggiore Trieste

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Anticipated)

November 1, 2017

Study Registration Dates

First Submitted

May 5, 2014

First Submitted That Met QC Criteria

May 5, 2014

First Posted (Estimate)

May 7, 2014

Study Record Updates

Last Update Posted (Actual)

February 10, 2017

Last Update Submitted That Met QC Criteria

February 9, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNITS01-2014

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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