Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Platelet-rich Fibrin With 1.2% Rosuvastatin in Chronic Periodontitis Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02645227
Recruitment Status : Completed
First Posted : January 1, 2016
Last Update Posted : January 5, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. A R Pradeep, 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 1.2% Rosuvastatin (RSV) with open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis patients

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Procedure: Open flap debridement (OFD) Procedure: OFD with Platelet rich fibrin (PRF) Procedure: OFD with PRF and 1.2% Rosuvastatin Phase 2 Phase 3

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: 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 Start Date : January 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group 1
Open flap debridement (OFD)
Procedure: Open flap debridement (OFD)
Oral prophylaxis followed by OFD for treating bone defect

Active Comparator: Group 2
OFD with Platelet rich fibrin (PRF)
Procedure: OFD with Platelet rich fibrin (PRF)
Oral prophylaxis followed by OFD with PRF placement into the bone defect

Active Comparator: Group 3
OFD with PRF and 1.2% Rosuvastatin
Procedure: OFD with PRF and 1.2% Rosuvastatin
Oral prophylaxis followed by OFD with PRF and 1.2% Rosuvastatin placement into the bone defect




Primary Outcome Measures :
  1. defect depth reduction (%) [ Time Frame: Change from baseline to 9 months ]
    assessed in percentage


Secondary Outcome Measures :
  1. probing depth (mm) [ Time Frame: Change from baseline to 9 months ]
    measured in mm

  2. clinical attachment level (mm) [ Time Frame: Change from baseline to 9 months ]
    measured in mm

  3. modified sulcus bleeding index [ Time Frame: Change from baseline to 9 months ]
    scale from 0-3

  4. plaque index [ Time Frame: Change from baseline to 9 months ]
    scale from 0-3



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02645227


Locations
Layout table for location information
India
Government Dental College and Research Institute
Bangalore, Karnataka, India, 560002
Sponsors and Collaborators
Government Dental College and Research Institute, Bangalore
Investigators
Layout table for investigator information
Study Director: Avani Pradeep, MDS Government Dental Colleege & Research Institute, Bangalore

Layout table for additonal information
Responsible Party: Dr. A R Pradeep, Professor and Head, Department of Periodontology, Government Dental College and Research Institute, Bangalore
ClinicalTrials.gov Identifier: NCT02645227     History of Changes
Other Study ID Numbers: GDCRI/ACM/PG/PhD/12/2013-14V
First Posted: January 1, 2016    Key Record Dates
Last Update Posted: January 5, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Layout table for MeSH terms
Chronic Periodontitis
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors