Back to resultsPiezosurgery in the Treatment of Class II Furcation Involvement
Primary Purpose
Furcation Defects
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Piezosurgery with biomaterial mp3 + bracket
Piezosurgery with biomaterial mp3
Piezosurgery
Sponsored by
About this trial
This is an interventional treatment trial for Furcation Defects focused on measuring class II furcation involvement, piezoelectric surgery, regeneration, biomaterial
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
Sites / Locations
- Matteo Visintin
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
OFD with piezosurgery
OFD with piezosurgery+biomaterial
OFD with piezosurgery+mp3+bracket
Arm Description
Open flap debridement with Piezosurgery
Open flap debridement with Piezosurgery with biomaterial mp3
Open flap debridement with Piezosurgery with biomaterial mp3 + bracket
Outcomes
Primary Outcome Measures
Horizontal probing depth (PH)
horizontal probing depth
Secondary Outcome Measures
Plaque index (PI)
plaque index
Bleeding on probing (BoP)
bleeding on probing
Pocket probing depth (PPD)
pocket probing depth
Furcation closure (FC)
furcation closure
Clinical attachment level (CAL)
clinical attachment level
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02132806
Brief Title
Piezosurgery in the Treatment of Class II Furcation Involvement
Official Title
Piezosurgery in the Treatment of Class II Furcation Involvement
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
November 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Matteo Visintin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Furcation Defects
Keywords
class II furcation involvement, piezoelectric surgery, regeneration, biomaterial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OFD with piezosurgery
Arm Type
Experimental
Arm Description
Open flap debridement with Piezosurgery
Arm Title
OFD with piezosurgery+biomaterial
Arm Type
Experimental
Arm Description
Open flap debridement with Piezosurgery with biomaterial mp3
Arm Title
OFD with piezosurgery+mp3+bracket
Arm Type
Experimental
Arm Description
Open flap debridement with Piezosurgery with biomaterial mp3 + bracket
Intervention Type
Procedure
Intervention Name(s)
Piezosurgery with biomaterial mp3 + bracket
Intervention Type
Procedure
Intervention Name(s)
Piezosurgery with biomaterial mp3
Intervention Type
Procedure
Intervention Name(s)
Piezosurgery
Primary Outcome Measure Information:
Title
Horizontal probing depth (PH)
Description
horizontal probing depth
Time Frame
180 days
Secondary Outcome Measure Information:
Title
Plaque index (PI)
Description
plaque index
Time Frame
180 days
Title
Bleeding on probing (BoP)
Description
bleeding on probing
Time Frame
180 days
Title
Pocket probing depth (PPD)
Description
pocket probing depth
Time Frame
180 days
Title
Furcation closure (FC)
Description
furcation closure
Time Frame
180 days
Title
Clinical attachment level (CAL)
Description
clinical attachment level
Time Frame
180 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matteo Visintin
Organizational Affiliation
UCO Clinica Odontoiatrica e Stomatologica - Ospedale Maggiore Trieste
Official's Role
Principal Investigator
Facility Information:
Facility Name
Matteo Visintin
City
Trieste
State/Province
TS
ZIP/Postal Code
34100
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Piezosurgery in the Treatment of Class II Furcation Involvement
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