Platelet Rich Fibrin+1% Alendronate in Treatment of Chronic Periodontitis

Phase 2

Completed

• Conditions: Chronic Periodontitis
• Interventions: Procedure: OFD with Platelet rich fibrin (PRF); Procedure: Open flap debridement (OFD); Procedure: OFD with Platelet rich fibrin (PRF)+1% Alendronate

• Registration Number: NCT02518152
• Lead Sponsor: Government Dental College and Research Institute, Bangalore

Brief Summary

The present study is designed to evaluate the combined efficacy of Platelet Rich Fibrin (PRF) and 1% Alendronate (ALN) with open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis patients.

Detailed Description

Background: Platelet-rich fibrin (PRF) is a second-generation platelet concentrate, act as reservoirs of growth factors and cytokines which are the key factors for regeneration of the 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 with open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis patients.

Methods: Ninety patients with single defects were categorized into three groups: OFD alone, OFD with PRF,OFD with PRF+1% ALN. Clinical parameters; site specific plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), clinical attachment level (CAL) and gingival marginal level (GML) were recorded at baseline before surgery and 9 months post-operatively. Percentage radiographic intra-bony defect depth reduction (IBD) was evaluated at baseline and 9 months.

Study Timeline

• Study Start: 2014-10
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-08
• Study First Submitted: 2015-08-04
• Study First Submitted QC: 2015-08-06
• Last Update Submitted: 2015-08-06
• Study First Posted: 2015-08-07
• Last Update Posted: 2015-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

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 (<200,000/mm3);
• Pregnancy/lactation;
• Smoking and tobacco use in any form
• Immunocompromised individuals.
• Those having unacceptable oral hygiene (plaque index27 [PI] >1.5) after reevaluation of Phase I therapy .
• Teeth with furcation involvement, non-vital teeth, carious teeth indicated for restorations and mobility of at least grade II were also excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	OFD with Platelet rich fibrin (PRF)	SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF) for treating periodontal defect
Group 1	Open flap debridement (OFD)	Scaling and Root Planing (SRP) with Open flap debridement (OFD) alone for treating periodontal defect
Group 3	OFD with Platelet rich fibrin (PRF)+1% Alendronate	SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1% Alendronate for treating periodontal defect

Primary Outcome Measures

Name	Time	Method
defect depth reduction (%)	Change from baseline to 9 months	assessed in percentage

Secondary Outcome Measures

Name	Time	Method
plaque index	Change from baseline to 9 months	scale from 0-3
probing depth (mm)	Change from baseline to 9 months	measured in mm
gingival marginal level (mm)	Change from baseline to 9 months	measured in mm
modified sulcus bleeding index	Change from baseline to 9 months	scale from 0-3
clinical attachment level (mm)	Change from baseline to 9 months	measured in mm

Trial Locations

Locations (1)

Government Dental College and Research Institute; 🇮🇳 Bangalore, Karnataka, India