Treatment of Periodontal Intrabony Defects Using Autologous Platelet Rich Fibrin vs Titanium Platelet Rich Fibrin

July 29, 2015 updated by: Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore

Treatment of Periodontal Intrabony Defects Using Autologous Platelet Rich Fibrin and Titanium Platelet Rich Fibrin: A Randomized Clinical Comparative Study

Background: To compare the effectiveness of open flap debridement (OFD) alone and OFD along with either Autologous Platelet Rich Fibrin (PRF) or Titanium Platelet Rich Fibrin (TPRF) in the treatment of intrabony defects (IBDs).

Materials and methods: Study was conducted on subjects reporting to the Department of Periodontics, The Oxford Dental College and Hospital, Bangalore. 38 subjects with 90 periodontal IBDs of moderate to severe periodontitis were selected and assigned to OFD alone (group I) or OFD with Autologous PRF (group II) or OFD with TPRF (group III). In each subject, a minimum number of two sextants were present with probing pocket depths (PPD) ≥5mm in at least three teeth.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 2
  • Phase 3

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
        • Government Dental College and Research Institute
      • Bangalore, Karnataka, India, 560068
        • The Oxford Dental College

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

20 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • presence of minimum 20 permanent teeth
  • age group 20-55 years
  • radiographic evidence of periodontal IBDs
  • probing pocket depth (PPD) >5mm in minimum two sextants in at least three teeth
  • clinical attachment (CA) loss of ≥ 3mm.

Exclusion Criteria:

  • Systemically compromised subjects
  • those on medications (corticosteroids/ bisphosphonate therapy) that may interfere with wound healing
  • grade III tooth mobility
  • smokers and alcoholic subjects
  • pregnant and lactating mothers
  • subjects who underwent periodontal treatment within a period of 1 year.

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: Group 1
SRP with Open flap debridement (OFD) alone for treating periodontal pocket
Procedure: Open flap debridement (OFD)
Oral prophylaxis followed by Open flap debridement (OFD)
Active Comparator: Group 2
SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement into bone defect
Procedure: OFD with Platelet rich fibrin (PRF)
Oral prophylaxis followed by Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement into the bone defect
Active Comparator: Group 3
SRP with Open flap debridement (OFD) with Titanium Platelet rich fibrin (TPRF) placement into bone defect
Procedure: OFD with Titanium Platelet rich fibrin (TPRF)
Oral prophylaxis followed by Open flap debridement (OFD) with Titanium Platelet rich fibrin (TPRF) placement into the bone defect

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
defect depth reduction (DDR)
Time Frame: Change from baseline to 9 months
Change from baseline to 9 months
change in clinical attachment level (CAL)
Time Frame: Change from baseline to 9 months
Change from baseline to 9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
change in probing pocket depths (PPD)
Time Frame: Change from baseline to 9 months
Change from baseline to 9 months
change in plaque index (PI)
Time Frame: Change from baseline to 9 months
Change from baseline to 9 months

Collaborators and Investigators

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

Sponsor

Government Dental College and Research Institute, Bangalore

Collaborators

The Oxford Dental College, Hospital and Research Center, Bangalore, India

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

June 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

July 23, 2015

First Submitted That Met QC Criteria

July 29, 2015

First Posted (Estimate)

July 31, 2015

Study Record Updates

Last Update Posted (Estimate)

July 31, 2015

Last Update Submitted That Met QC Criteria

July 29, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 224/2013-14

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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