Platelet-rich Fibrin With 1.2% Rosuvastatin in Chronic Periodontitis Treatment
1 other identifier
interventional
90
1 country
1
Brief Summary
The present study is designed to evaluate the combined efficacy of Platelet Rich Fibrin (PRF) and 1.2% Rosuvastatin (RSV) with open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2015
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 28, 2015
CompletedFirst Posted
Study publicly available on registry
January 1, 2016
CompletedJanuary 5, 2016
January 1, 2016
9 months
December 28, 2015
January 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
defect depth reduction (%)
assessed in percentage
Change from baseline to 9 months
Secondary Outcomes (4)
probing depth (mm)
Change from baseline to 9 months
clinical attachment level (mm)
Change from baseline to 9 months
modified sulcus bleeding index
Change from baseline to 9 months
plaque index
Change from baseline to 9 months
Study Arms (3)
Group 1
ACTIVE COMPARATOROpen flap debridement (OFD)
Group 2
ACTIVE COMPARATOROFD with Platelet rich fibrin (PRF)
Group 3
ACTIVE COMPARATOROFD with PRF and 1.2% Rosuvastatin
Interventions
Oral prophylaxis followed by OFD for treating bone defect
Oral prophylaxis followed by OFD with PRF placement into the bone defect
Oral prophylaxis followed by OFD with PRF and 1.2% Rosuvastatin placement into the bone defect
Eligibility Criteria
You may qualify if:
- Systemically healthy with CP diagnosis16 having probing depth (PD) ≥5mm, clinical attachment (CA) level ≥3mm and vertical bone loss ≥3mm on intraoral periapical radiographs (IOPAR) without any antibiotic or periodontal therapy in the last 6 months.
You may not qualify if:
- History of statin allergy, statin therapy, any systemic condition or medication altering the periodontal condition, immune-compromised state, hematologic disorders, insufficient platelet count (\<200,000/mm3), aggressive periodontitis, substance/tobacco abuse and lactating and pregnant females.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Government Dental College and Research Institute
Bangalore, Karnataka, 560002, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Avani Pradeep, MDS
Government Dental Colleege & Research Institute, Bangalore
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Head, Department of Periodontology
Study Record Dates
First Submitted
December 28, 2015
First Posted
January 1, 2016
Study Start
January 1, 2015
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
January 5, 2016
Record last verified: 2016-01