Platelet Rich Fibrin+1% Alendronate in Treatment of Chronic Periodontitis
- Conditions
- Chronic Periodontitis
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
Not provided
- 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
- 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
Government Dental College and Research Institute🇮🇳Bangalore, Karnataka, India