Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Platelet Rich Fibrin Combined With Simvastatin for Treatment of Intrabony Defect in Chronic Periodontitis

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: NCT02120872
Recruitment Status : Completed
First Posted : April 23, 2014
Last Update Posted : April 23, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore

Brief Summary:
The purpose of the present study was to investigate the efficacy of autologous Platelet rich fibrin (PRF) or PRF and Simvastatin (SMV) with open flap debridement (OFD) in the treatment of three wall intrabony defects in comparison to OFD alone.

Condition or disease Intervention/treatment Phase
Three Wall Intrabony Defects in Chronic Periodontitis Drug: Platelet rich fibrin and simvastatin Biological: Platelet rich fibrin Procedure: Open Flap Debridement alone Phase 2

Detailed Description:
90 systemically healthy subjects were divided randomly into three groups (30 subjects in each group, per subject one site). Control group consisted of the sites treated with OFD and test groups sites were treated with OFD with autologous PRF or PRF with SMV. Site-specific plaque index (PI), sulcus bleeding index (mSBI), probing depth (PD), relative attachment level (RAL) and intrabony defect (IBD) depth reduction was measured at baseline and 9 month after surgery.

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 Combined With 1.2mg Simvastatin for the Treatment of 3 - Wall Intrabony Defects in Chronic Periodontitis: A Randomized Controlled Clinical Trial
Study Start Date : February 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Simvastatin

Arm Intervention/treatment
Active Comparator: PRF and SMV Group
sites treated with Open Flap Debridement with Platelet Rich Fibrin along with Simvastatin
Drug: Platelet rich fibrin and simvastatin
Three wall intrabony defect sites treated with Open Flap Debridement. 0.1 mL prepared SMV gel (1.2 mg/0.1 mL) was mixed with PRF. The PRF - SMV mixture was delivered to the defect.

Sham Comparator: PRF Group
sites treated with Open Flap Debridement with autologous Platelet Rich Fibrin
Biological: Platelet rich fibrin
Three wall intrabony defect sites treated with Open Flap Debridement. PRF was placed into the intrabony defect.

OFD Group
sites treated with Open Flap Debridement i.e. conventional flap surgery
Procedure: Open Flap Debridement alone
Three wall intrabony defect sites treated with Open Flap Debridement only. No PRF or SMV was delivered to the defect.




Primary Outcome Measures :
  1. The primary outcome measure of the study was defect depth reduction evaluated radiographically [ Time Frame: At baseline and 9 month after surgery ]

Secondary Outcome Measures :
  1. Probing Depth [ Time Frame: At baseline and 9 month after surgery ]
  2. Relative Attachment Level [ Time Frame: At baseline and 9 month after syrgery ]
  3. modified Sulcul Bleeding Index [ Time Frame: At baseline and 9 month after surgery ]
  4. Plaque Index [ Time Frame: At baseline and 9 month after surgery ]


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 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects with the diagnosis of chronic periodontitis
  • presence of three walled intrabony defects (IBD) ≥ 3 mm deep (distance between alveolar crest and base of the defect on intraoral periapical radiograph [IOPA])
  • interproximal probing depth (PD) ≥ 5 mm following scaling and root planing (SRP) in asymptomatic tooth

Exclusion Criteria:

  • Subjects, with the diagnosis of aggressive periodontitis,
  • with known systemic illness and taking medications known to affect the outcomes of periodontal therapy
  • insufficient platelet count (< 200,000/mm3),
  • pregnancy / lactation
  • use of any form of tobacco
  • unacceptable oral hygiene (if plaque index [PI] (Silness & Loe 1964) >1.5) after the reevaluation of phase I therapy
  • teeth with furcation defects
  • non-vital
  • mobility of tooth ≥ Grade II

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): NCT02120872


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
Principal Investigator: Avani R Pradeep, MDS Government Dental College and Research Institute, Bangalore

Layout table for additonal information
Responsible Party: Dr. A R Pradeep, Professor and Head of Department, Government Dental College and Research Institute, Bangalore
ClinicalTrials.gov Identifier: NCT02120872     History of Changes
Other Study ID Numbers: GDCRI/ACM/PG/PhD/2011-2012/E
First Posted: April 23, 2014    Key Record Dates
Last Update Posted: April 23, 2014
Last Verified: April 2014

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