Comparison of PRP & DFDBA vs. DFDBA in Intrabony Periodontal Defects

May 23, 2023 updated by: Dr. Pallavi Meshram, Government Dental College and Hospital, India

Comparison of Efficacy of Autologous Platelet - Rich Plasma Combined With Demineralized Freeze - Dried Bone Allograft Versus Demineralized Freeze - Dried Bone Allograft: A Randomized Clinical Trial in Central India

The purpose of this clinical trial is to compare the results in subjects with periodontitis using subjects own blood - Platelet-rich plasma (PRP) combined with bone graft material, namely, Demineralized Freeze - Dried Bone Allograft (DFDBA) or DFDBA alone in the treatment of bone defects around the teeth.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After being informed about the study and potential risks, 13 patients giving written informed consent and who meet the eligibility requirements were randomly allocated in a single blind manner (participants) to test group (PRP combined with DFDBA) or control group (DFDBA).

33 sites (18 test, 15 control unpaired defects) were treated - 1) to investigate the possible additional effects of PRP when combined with DFDBA, and 2) to compare the clinical and radiographic outcomes obtained in test and control groups,12 months post - operatively.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

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
    • Maharashtra
      • Nagpur, Maharashtra, India, 440003
        • 212, Department of Periodontology, Government Dental college and Hospital

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Outpatients
  • with chronic periodontitis
  • who were free of local or systemic disease
  • who had not received any type of periodontal therapy in the last six months
  • radiograph showing at least one angular defect in any quadrant
  • the involved teeth were vital and asymptomatic
  • the site of interest had at least 2 mm of keratinized gingiva on the facial aspect of the selected teeth

Exclusion Criteria:

  • Patients with abnormal platelet count
  • allergic to chlorhexidine or any other medicine used in the study
  • showing unacceptable oral hygiene compliance during / after the phase I therapy;
  • pregnant or lactating mothers;
  • smokers
  • endodontically involved teeth
  • patients under any medication known to interfere with periodontal healing. e.g., corticosteroids
  • on anticoagulant therapy
  • patients with transferable jobs or who were uncooperative
  • patients participating in other dental clinical trials.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRP combined with DFDBA
Open flap debridement, followed by placement of PRP combined with DFDBA
Other: PRP combined with DFDBA
Periodontal intrabony defects were treated with open flap debridement followed by placement of PRP combined with DFDBA
Active Comparator: DFDBA
Open flap debridement, followed by placement of DFDBA
Other: DFDBA
Periodontal intrabony defects were treated with open flap debridement followed by placement of PRP combined with DFDBA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Probing Pocket Depth (PPD) from baseline to 12 months
Time Frame: baseline to 12 months
PPD is vertical measurement from the free gingival margin to the base of the pocket measured to the nearest millimeter using a UNC (University of North Carolina) -15 periodontal probe.
baseline to 12 months
Change in Periodontal Attachment Level (PAL) from baseline to 12 months
Time Frame: baseline to 12 months
PAL is vertical measurement recorded with the help of customized acrylic stent from a fixed reference point to the base of the pocket measured to the nearest millimeter using UNC - 15 probe
baseline to 12 months
Change in Gingival Recession (GR) from baseline to 12 months
Time Frame: baseline to 12 months
GR is vertical measurement recorded with the help of customized acrylic stent from a fixed reference point to the gingival margin measured to the nearest millimeter using UNC-15 probe
baseline to 12 months
Change in Crestal bone resorption from baseline to 12 months
Time Frame: baseline to 12 months
Crestal bone resorption is the distance from Cementoenamel Junction to the Alveolar Crest (CEJ- AC); measured in millimeters using standardized intraoral periapical (IOPA) radiographs along with a calibrated grid of the tooth of interest
baseline to 12 months
Change in Defect fill from baseline to 12 months
Time Frame: baseline to 12 months
Defect fill is the distance from Cementoenamel Junction to Base of the Defect (CEJ- BD); measured in millimeters using standardized intraoral periapical (IOPA) radiographs along with a calibrated grid of the tooth of interest
baseline to 12 months
Change in Defect resolution from baseline to 12 months
Time Frame: baseline to 12 months
Defect resolution is the distance from the Alveolar Crest to Base of the Defect (AC - BD); measured in millimeters using standardized intraoral periapical (IOPA) radiographs along with a calibrated grid of the tooth of interest
baseline to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque Index
Time Frame: baseline to 12 months
Silness and Loe, 1964
baseline to 12 months
Gingival Index
Time Frame: baseline to 12 months
Loe and Silness, 1963
baseline to 12 months

Collaborators and Investigators

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

Sponsor

Government Dental College and Hospital, India

Investigators

  • Principal Investigator: Pallavi A Meshram, MDS, Government Dental College and Hospital, Nagpur, India
  • Study Chair: Ramreddy K Yeltiwar, MDS, Rungta College of Dental Sciences and Research, Bhilai, India.
  • Study Director: Mangesh B Phadnaik, MDS, Government Dental College and Hospital, Nagpur, India

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

March 2, 2015

First Submitted That Met QC Criteria

May 23, 2023

First Posted (Actual)

June 2, 2023

Study Record Updates

Last Update Posted (Actual)

June 2, 2023

Last Update Submitted That Met QC Criteria

May 23, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMeshram

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected Individual Participant Data

IPD Sharing Time Frame

starting 6 months after publication

IPD Sharing Access Criteria

to other researchers

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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