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Platelet Rich Fibrin+1% Alendronate in Treatment of Mandibular Degree II 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% Alendronate (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:

  • Presence of buccal Class 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:

  • Systemic conditions known to affect the periodontal status;
  • Medications known to affect the outcomes of periodontal therapy;
  • Hematological disorders and insufficient platelet count (<200,000/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
  • Aggressive periodontitis

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% Alendronate for treating furcation defect

Outcomes

Primary Outcome Measures

Radiographic bone fill
assessed in percentage

Secondary Outcome Measures

probing depth
measured in mm
Relative vertical attachment level
measured in mm
Relative horizontal attachment level
measured in mm
modified sulcus bleeding index
0-3 scale
plaque index
0-3 scale

Full Information

First Posted
November 15, 2015
Last Updated
November 17, 2015
Sponsor
Government Dental College and Research Institute, Bangalore
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1. Study Identification

Unique Protocol Identification Number
NCT02609061
Brief Title
Platelet Rich Fibrin+1% Alendronate in Treatment of Mandibular Degree II Furcation Defects
Official Title
Platelet Rich Fibrin Combined With 1% Alendronate Gel in Treatment of Mandibular Degree II Furcation Defects: A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Government Dental College and Research Institute, Bangalore

4. Oversight

5. Study Description

Brief Summary
The present study was designed to evaluate the combined efficacy of PRF and 1% ALN in the treatment of mandibular degree II furcation defects when compared with PRF and open flap debridement (OFD) alone.
Detailed Description
Background: Various regenerative materials have been introduced and tested in the treatment of furcation defects. Platelet-rich fibrin (PRF) is a reservoir of growth factors and cytokines which are the key factors for regeneration of bone and maturation of the soft tissue. Alendronate (ALN), a potent member of bisphosphonate group is known to promote tissue regeneration by inhibiting osteoclastic bone resorption and promoting osteoblastogenesis. The present study was designed to evaluate the combined efficacy of PRF and 1% ALN in the treatment of mandibular degree II furcation defects when compared with PRF and open flap debridement (OFD) alone. Methods: Seventy two mandibular furcation defects were treated with either OFD alone (Group 1), OFD with PRF (Group 2), and OFD with PRF+1% ALN (Group 3). Clinical parameters; site specific plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), relative vertical attachment level (RVAL) and relative horizontal attachment level (RHAL), intrabony defect depth (IBD) were recorded at baseline before surgery and 9 months post-operatively. Percentage radiographic defect fill was evaluated 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
ParticipantInvestigator
Allocation
Randomized
Enrollment
72 (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% Alendronate 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% Alendronate (Drug) in gel form
Intervention Description
Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1% Alendronate gel placement
Primary Outcome Measure Information:
Title
Radiographic bone fill
Description
assessed in percentage
Time Frame
baseline to 9 months
Secondary Outcome Measure Information:
Title
probing depth
Description
measured in mm
Time Frame
baseline to 9 months
Title
Relative vertical attachment level
Description
measured in mm
Time Frame
baseline to 9 months
Title
Relative horizontal attachment level
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: Presence of buccal Class 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: Systemic conditions known to affect the periodontal status; Medications known to affect the outcomes of periodontal therapy; Hematological disorders and insufficient platelet count (<200,000/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 Aggressive periodontitis
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

Citations:
PubMed Identifier
27712462
Citation
Kanoriya D, Pradeep AR, Garg V, Singhal S. Mandibular Degree II Furcation Defects Treatment With Platelet-Rich Fibrin and 1% Alendronate Gel Combination: A Randomized Controlled Clinical Trial. J Periodontol. 2017 Mar;88(3):250-258. doi: 10.1902/jop.2016.160269. Epub 2016 Oct 7.
Results Reference
derived

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Platelet Rich Fibrin+1% Alendronate in Treatment of Mandibular Degree II Furcation Defects

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