Platelet-rich Fibrin With 1.2% Rosuvastatin in Chronic Periodontitis Treatment
Primary Purpose
Chronic Periodontitis
Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Open flap debridement (OFD)
OFD with Platelet rich fibrin (PRF)
OFD with PRF and 1.2% Rosuvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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
Open flap debridement (OFD)
OFD with Platelet rich fibrin (PRF)
OFD with PRF and 1.2% Rosuvastatin
Outcomes
Primary Outcome Measures
defect depth reduction (%)
assessed in percentage
Secondary Outcome Measures
probing depth (mm)
measured in mm
clinical attachment level (mm)
measured in mm
modified sulcus bleeding index
scale from 0-3
plaque index
scale from 0-3
Full Information
NCT ID
NCT02645227
First Posted
December 28, 2015
Last Updated
January 1, 2016
Sponsor
Government Dental College and Research Institute, Bangalore
1. Study Identification
Unique Protocol Identification Number
NCT02645227
Brief Title
Platelet-rich Fibrin With 1.2% Rosuvastatin in Chronic Periodontitis Treatment
Official Title
Platelet-rich Fibrin With 1.2% Rosuvastatin for the Treatment of Intrabony Defects in Chronic Periodontitis: A Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 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
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
ABSTRACT Background: Regenerative periodontal therapy encompasses the use of various bioactive agents that are not only inflammo-modulatory but also osteoclast-inhibitory or rather, osteostimulative. The hypolipidaemic Statin group of drugs, particularly Rosuvastatin (RSV), are known to be associated with alveolar bone formation and periodontal improvements. Platelet analogues like Platelet rich fibrin (PRF), being rich sources of growth factors, have also come into widespread periodontal regenerative use. The aim of the study is to evaluate and compare the efficacy of open-flap debridement (OFD) with or without PRF or PRF + 1.2% RSV gel in the treatment of intrabony defects (IBDs) in chronic periodontitis (CP) patients.
Methods: Ninety individuals with a total of 90 IBDs were randomly assigned to one of the 3 treatment groups: 1) OFD alone, 2) OFD + PRF and 3) OFD + PRF + 1.2% RSV gel placement. Plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), clinical attachment (CA) level and IBD depth were recorded at baseline and at 9 months post-operatively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Open flap debridement (OFD)
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
OFD with Platelet rich fibrin (PRF)
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
OFD with PRF and 1.2% Rosuvastatin
Intervention Type
Procedure
Intervention Name(s)
Open flap debridement (OFD)
Intervention Description
Oral prophylaxis followed by OFD for treating bone defect
Intervention Type
Procedure
Intervention Name(s)
OFD with Platelet rich fibrin (PRF)
Intervention Description
Oral prophylaxis followed by OFD with PRF placement into the bone defect
Intervention Type
Procedure
Intervention Name(s)
OFD with PRF and 1.2% Rosuvastatin
Intervention Description
Oral prophylaxis followed by OFD with PRF and 1.2% Rosuvastatin placement into the bone defect
Primary Outcome Measure Information:
Title
defect depth reduction (%)
Description
assessed in percentage
Time Frame
Change from baseline to 9 months
Secondary Outcome Measure Information:
Title
probing depth (mm)
Description
measured in mm
Time Frame
Change from baseline to 9 months
Title
clinical attachment level (mm)
Description
measured in mm
Time Frame
Change from baseline to 9 months
Title
modified sulcus bleeding index
Description
scale from 0-3
Time Frame
Change from baseline to 9 months
Title
plaque index
Description
scale from 0-3
Time Frame
Change from baseline to 9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Avani Pradeep, MDS
Organizational Affiliation
Government Dental Colleege & Research Institute, Bangalore
Official's Role
Study Director
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
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Platelet-rich Fibrin With 1.2% Rosuvastatin in Chronic Periodontitis Treatment
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