Piezosurgery in the Treatment of Class II Furcation Invol... | NCT02132806

Studies
Piezosurgery in the Treatment of Class II Furcation Involvement

NCT02132806

Sponsor

Matteo Visintin

Status

Unknown status

Last Update Posted

Feb 10, 2017Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Furcation Defects

Interventions

Piezosurgery with biomaterial mp3 + bracket
Piezosurgery with biomaterial mp3
Piezosurgery

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Oct 2015Actual

Completion Date

Nov 2017Estimated

First Submitted Date

May 5, 2014

First Submission Date that Met QC Criteria

May 5, 2014

First Posted Date

May 7, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2017

Last Update Posted Date

Feb 10, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OFD with piezosurgery	Experimental	Open flap debridement with Piezosurgery	Procedure: Piezosurgery
OFD with piezosurgery+biomaterial	Experimental	Open flap debridement with Piezosurgery with biomaterial mp3	Procedure: Piezosurgery with biomaterial mp3
OFD with piezosurgery+mp3+bracket	Experimental	Open flap debridement with Piezosurgery with biomaterial mp3 + bracket	Procedure: Piezosurgery with biomaterial mp3 + bracket

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Piezosurgery with biomaterial mp3 + bracket	Procedure		OFD with piezosurgery+mp3+bracket
Piezosurgery with biomaterial mp3

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Plaque index (PI)	plaque index	180 days
Bleeding on probing (BoP)	bleeding on probing	180 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matteo Visintin	UCO Clinica Odontoiatrica e Stomatologica - Ospedale Maggiore Trieste	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Matteo Visintin		Trieste	TS	34100	Italy

Condition Browse Module

MeSH Terms

ID	Term
D017823	Furcation Defects

Ancestor Terms

ID	Term
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D059745	Piezosurgery

Ancestor Terms

ID	Term
D059708	Ultrasonic Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided