PRF+1% MF for Class II Mandibular Furcation Defects
Primary Purpose
Furcation Defects
Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Open flap debridement (OFD)
OFD with Platelet rich fibrin (PRF)
OFD with Platelet rich fibrin (PRF)+1% Metformin (Drug) in gel form
Sponsored by
About this trial
This is an interventional treatment trial for Furcation Defects
Eligibility Criteria
Inclusion Criteria:
- Buccal degree II furcation defects in endodontically vital, asymptomatic mandibular first and second molars with a radiolucency in the furcation area on an intraoral periapical radiograph with probing depth (PD) ≥ 5mm and horizontal ≥ PD 3mm after phase I therapy i.e, scaling and root planing (SRP);
- No history of antibiotic or periodontal therapy in the preceding 6 months.
Exclusion Criteria:
Aggressive periodontitis patients
- Systemic conditions known to affect the periodontal status;
- Medications known to affect the outcomes of periodontal therapy;
- Hematological disorders and insufficient platelet count (<100,000/mm3);
- Pregnancy/lactation;
- Smoking and tobacco use in any form
- Immunocompromised individuals;
- Those having unacceptable oral hygiene (plaque index [PI] >1.5).
- Teeth with furcation involvement, non-vital teeth, and carious teeth indicated for restorations and mobility of at least grade II were also excluded.
Sites / Locations
- Government Dental College and Research Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group 1
Group 2
Group 3
Arm Description
Scaling and Root Planing (SRP) with Open flap debridement (OFD) alone for treating furcation defect
SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF) for treating furcation defect
SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1% Metformin for treating furcation defect
Outcomes
Primary Outcome Measures
Radiographic bone fill assessed in percentage
assessed in percentage
Secondary Outcome Measures
probing depth measured in mm
measured in mm
Relative vertical attachment level measured in mm
measured in mm
Relative horizontal attachment level measured in mm
measured in mm
modified sulcus bleeding index
0-3 scale
plaque index
0-3 scale
Full Information
NCT ID
NCT03207698
First Posted
July 1, 2017
Last Updated
July 1, 2017
Sponsor
Government Dental College and Research Institute, Bangalore
1. Study Identification
Unique Protocol Identification Number
NCT03207698
Brief Title
PRF+1% MF for Class II Mandibular Furcation Defects
Official Title
Evaluation of Adjunctive Effect of 1% Metformin To Platelet Rich Fibrin For Mandibular Class II Furcation Defects: A Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Government Dental College and Research Institute, Bangalore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the present trial is to evaluate the efficacy of PRF with 1% MF in treatment of mandibular class II furcation defects and its comparison to PRF and access therapy alone.
Detailed Description
Background: For improving efficacy and outcomes of regenerative therapy for furcation defects, various materials has been investigated in addition to access therapy. Platelet-rich fibrin (PRF) having concentrated growth factors and cytokines and Metformin (MF), an efficacious member of biguanide group are known to enhance periodontal regeneration. The aim of the present trial is to evaluate the efficacy of PRF with 1% MF in treatment of mandibular class II furcation defects and its comparison to PRF and access therapy alone.
Methods: This randomized trial was conducted on 75 patients with mandibular class II furcation defects. Defects were surgically treated with either access therapy alone (Group 1), access therapy+PRF (Group 2), and access therapy+ PRF+1% MF (Group 3). Clinical parameters like probing depth (PD), relative clinical attachment level {vertical (RVCAL) and horizontal (RHCAL)}, modified sulcus bleeding index (mSBI) and site specific plaque index (PI) were evaluated at baseline and 9 months post-operatively. Radiological assessment of bone defect fill was done at baseline and 9 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Furcation Defects
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Scaling and Root Planing (SRP) with Open flap debridement (OFD) alone for treating furcation defect
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF) for treating furcation defect
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1% Metformin for treating furcation defect
Intervention Type
Procedure
Intervention Name(s)
Open flap debridement (OFD)
Intervention Description
Open flap debridement (OFD) alone
Intervention Type
Procedure
Intervention Name(s)
OFD with Platelet rich fibrin (PRF)
Intervention Description
Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement
Intervention Type
Procedure
Intervention Name(s)
OFD with Platelet rich fibrin (PRF)+1% Metformin (Drug) in gel form
Intervention Description
Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1.2% Atorvastatin gel placement
Primary Outcome Measure Information:
Title
Radiographic bone fill assessed in percentage
Description
assessed in percentage
Time Frame
baseline to 9 months
Secondary Outcome Measure Information:
Title
probing depth measured in mm
Description
measured in mm
Time Frame
baseline to 9 months
Title
Relative vertical attachment level measured in mm
Description
measured in mm
Time Frame
baseline to 9 months
Title
Relative horizontal attachment level measured in mm
Description
measured in mm
Time Frame
baseline to 9 months
Title
modified sulcus bleeding index
Description
0-3 scale
Time Frame
baseline to 9 months
Title
plaque index
Description
0-3 scale
Time Frame
baseline to 9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Buccal degree II furcation defects in endodontically vital, asymptomatic mandibular first and second molars with a radiolucency in the furcation area on an intraoral periapical radiograph with probing depth (PD) ≥ 5mm and horizontal ≥ PD 3mm after phase I therapy i.e, scaling and root planing (SRP);
No history of antibiotic or periodontal therapy in the preceding 6 months.
Exclusion Criteria:
Aggressive periodontitis patients
Systemic conditions known to affect the periodontal status;
Medications known to affect the outcomes of periodontal therapy;
Hematological disorders and insufficient platelet count (<100,000/mm3);
Pregnancy/lactation;
Smoking and tobacco use in any form
Immunocompromised individuals;
Those having unacceptable oral hygiene (plaque index [PI] >1.5).
Teeth with furcation involvement, non-vital teeth, and carious teeth indicated for restorations and mobility of at least grade II were also excluded.
Facility Information:
Facility Name
Government Dental College and Research Institute
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560002
Country
India
12. IPD Sharing Statement
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PRF+1% MF for Class II Mandibular Furcation Defects
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