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

Platelet Rich Fibrin Combined With 1% Alendronate Gel in Treatment of Mandibular Degree II Furcation Defects: A Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Furcation Defects
• Intervention / Treatment: Procedure: Open flap debridement (OFD); Procedure: OFD with Platelet rich fibrin (PRF); Procedure: OFD with Platelet rich fibrin (PRF)+1% Alendronate (Drug) in gel form

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 560002
      • Government Dental College and Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; Scaling and Root Planing (SRP) with Open flap debridement (OFD) alone for treating furcation defect	Procedure: Open flap debridement (OFD); Open flap debridement (OFD) alone
Active Comparator: Group 2; SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF) for treating furcation defect	Procedure: OFD with Platelet rich fibrin (PRF); Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement
Active Comparator: Group 3; SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1% Alendronate for treating furcation defect	Procedure: OFD with Platelet rich fibrin (PRF)+1% Alendronate (Drug) in gel form; Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1% Alendronate gel placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic bone fill	assessed in percentage	baseline to 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
modified sulcus bleeding index	0-3 scale	baseline to 9 months
plaque index	0-3 scale	baseline to 9 months
probing depth	measured in mm	baseline to 9 months
Relative vertical attachment level	measured in mm	baseline to 9 months
Relative horizontal attachment level	measured in mm	baseline to 9 months

Collaborators and Investigators

• Sponsor: Government Dental College and Research Institute, Bangalore

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: November 15, 2015
• First Submitted That Met QC Criteria: November 17, 2015
• First Posted (Estimate): November 20, 2015

Study Record Updates

• Last Update Posted (Estimate): November 20, 2015
• Last Update Submitted That Met QC Criteria: November 17, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Furcation Defects; Physiological Effects of Drugs; Bone Density Conservation Agents; Alendronate
• Other Study ID Numbers: GDCRI/ACM/PG/PhD/2/2013-2014T