NCT02132806

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

February 10, 2017

Status Verified

February 1, 2017

Enrollment Period

1.6 years

First QC Date

May 5, 2014

Last Update Submit

February 9, 2017

Conditions

Furcation Defects

Keywords

class II furcation involvementpiezoelectric surgeryregenerationbiomaterial

Outcome Measures

Primary Outcomes (1)

  • Horizontal probing depth (PH)

    horizontal probing depth

    180 days

Secondary Outcomes (5)

  • Plaque index (PI)

    180 days

  • Bleeding on probing (BoP)

    180 days

  • Pocket probing depth (PPD)

    180 days

  • Furcation closure (FC)

    180 days

  • Clinical attachment level (CAL)

    180 days

Study Arms (3)

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

Piezosurgery with biomaterial mp3 + bracketPROCEDURE
OFD with piezosurgery+mp3+bracket
Piezosurgery with biomaterial mp3PROCEDURE
OFD with piezosurgery+biomaterial
PiezosurgeryPROCEDURE
OFD with piezosurgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Matteo Visintin

Trieste, TS, 34100, Italy

Location

MeSH Terms

Conditions

Furcation Defects

Interventions

Piezosurgery

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Matteo Visintin

    UCO Clinica Odontoiatrica e Stomatologica - Ospedale Maggiore Trieste

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Student

Study Record Dates

First Submitted

May 5, 2014

First Posted

May 7, 2014

Study Start

March 1, 2014

Primary Completion

October 1, 2015

Study Completion

November 1, 2017

Last Updated

February 10, 2017

Record last verified: 2017-02

Locations

IT(1)