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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
Government Dental College and Research Institute, Bangalore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Furcation Defects

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

First Posted
July 1, 2017
Last Updated
July 1, 2017
Sponsor
Government Dental College and Research Institute, Bangalore
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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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