PLATELET RICH FIBRIN COMBINED WITH 1.2% ATORVASTATIN FOR TREATMENT OF INTRABONY DEFECTS IN CHRONIC PERIODONTITIS

April 17, 2014 updated by: Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore
Current study was designed to evaluate the combined efficacy of PRF and 1.2% ATV gel with open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560002
        • Govt Dental College and Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

the presence of 3- wall IBD ≥3 mm deep (distance between alveolar crest and base of the defect on an intraoral periapical radiograph [IOPA]) along with an interproximal probing depth (PD) ≥5 mm after phase I therapy (scaling and root planing [SRP]) in asymptomatic teeth.

Exclusion Criteria:

1) Agressive Periodontitis subjects; 2) Systemic conditions known to affect the periodontal status; 3) medications known to affect the outcomes of periodontal therapy; 4) Hematological disorders and insufficient platelet count (<200,000/mm3); 5) pregnancy/lactation; and 6) Smoking and tobacco use in any form 7) Immunocompromised individuals.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Platelet rich fibrin + atorvastatin
In Platelet rich fibrin+ATV group PRF combined with 10 µl of 1.2% ATV was inserted into the depth of the IBD
Drug: Platelet rich fibrin +Atorvastatin
Sham Comparator: Platelet rich fibrin
In Platelet rich fibrin group PRF was inserted into the depth of the IBD.
Drug: Platelet rich fibrin
Other: Open flap debridement
open flap debridement was followed by no grafting or regenerative intervention.
Procedure: open flap debridement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage radiographic defect depth reduction
Time Frame: 9 months from baseline
Defect depth reduction will be assessed from baseline to 9 month post operatively on radiographs
9 months from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in probing depth
Time Frame: 9 months from baseline
probing depth will be assessed from gingival margin to pocket depth at baseline and 9 months postoperatively
9 months from baseline
change in relative attachment level
Time Frame: 9 months from baseline
RAL will be assesed from fixed point on the stent at baseline and 9 months postoperatively
9 months from baseline
change in plaque levels
Time Frame: 9 months from baseline
plaque levels were assessed at baseline and 9 months postoperatively
9 months from baseline
change in gingival bleeding
Time Frame: 9 months from baseline
gingival bleeding was assesed at baseline and 9 months postoperatively
9 months from baseline
change in gingival margin levels
Time Frame: 9 months from baseline
change in gingival margin levels were assesed at baseline and 9 months
9 months from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Government Dental College and Research Institute, Bangalore

Investigators

  • Principal Investigator: Avani R Pradeep, MDS, Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

April 17, 2014

First Submitted That Met QC Criteria

April 17, 2014

First Posted (Estimate)

April 21, 2014

Study Record Updates

Last Update Posted (Estimate)

April 21, 2014

Last Update Submitted That Met QC Criteria

April 17, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GDCRI/ACM/PG/PhD/2011-2012/D

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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