Platelet Derived Growth Factor Stimulates Bone Fill and Rate of Attachment Level Gain

January 6, 2016 updated by: William Giannobile, University of Michigan
The aim of the study was to evaluate the safety and effectiveness of Platelet Derived Growth Factor (PDGF) mixed with b tricalcium phosphate (BTCP) for the treatment of advanced periodontal osseous defects at 6 months of healing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This triple blind, prospective and parallel arm trial was conducted in subjects requiring surgical treatment of a periodontal osseous defect.

Study Type

Interventional

Enrollment (Actual)

180

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

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan School of Dentistry

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • probing depth of 7mm or greater at baseline
  • following debridement, 4mm or greater vertical bone defect depth with at least one intact bony wall
  • sufficient keratinized tissue to allow complete tissue coverage of the defect
  • a radiographic base of the defect at least 3mm coronal to the apex of the tooth
  • no evidence of localized aggressive periodontitis
  • smoke less than 1 pack of cigarettes per day

Exclusion Criteria:

  • failure to maintain adequate oral hygiene
  • pregnant women or women intending to become pregnant
  • history of oral cancer within last 6 months or HIV
  • history within last year of periodontal surgery on study tooth
  • study tooth mobility greater than 2
  • study tooth exhibiting a class 3 furcation defect
  • signs of untreated acute infection at the surgical site, apical pathology, root fracture, severe root irregularities, cemental pearls, cementoenamel junction (CEJ) projections not easily removed, untreated carious lesions at the CEJ or on the root surface, subgingival restorations or restorations with open margins at or below CEJ
  • history within 6 months of weekly or more frequent use of smokeless chewing tobacco, pipe or cigar smoking, or more than 20 cigarettes a day
  • allergy to yeast derived products
  • investigational therapy within 30 days of surgery

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: B-TCP +buffer
Administration of synthetic beta-tricalcium phosphate (B-TCP) mixed in sodium acetate buffer only.
Biological: B-TCP +buffer
B-TCP mixed with sodium acetate buffer and placed into osseous defect once at baseline visit.
Experimental: B-TCP + 0.3 mg/ml rhPDGF-BB in buffer
Administration of synthetic beta-tricalcium phosphate (B-TCP) mixed with purified 0.3 mg/ml recombinant human platelet-derived growth factor (rhPDGF-BB) in sodium acetate buffer.
Biological: B-TCP + 0.3 mg/ml rhPDGF-BB in buffer
B-TCP mixed with sodium acetate buffer and 0.3 mg/ml rhPDGF-BB and placed into osseous defect once at baseline visit.
Experimental: B-TCP + 1.0 mg/ml rhPDGF-BB in buffer
Administration of synthetic beta-tricalcium phosphate (B-TCP) mixed with purified 1.0 mg/ml recombinant human platelet-derived growth factor (rhPDGF-BB) in sodium acetate buffer.
Biological: B-TCP + 1.0 mg/ml rhPDGF-BB in buffer
B-TCP mixed with sodium acetate buffer and 1.0 mg/ml rhPDGF-BB and placed into osseous defect once at baseline visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of CAL Gain
Time Frame: Baseline to 6 months
Measurements for the rate of clinical attachment levels (CAL)
Baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Gingival Recession (GR)
Time Frame: Baseline to 6 months
Measurements in changes of gingival recession (GR)
Baseline to 6 months

Collaborators and Investigators

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

Sponsor

University of Michigan

Investigators

  • Principal Investigator: William Giannobile, DDS, DMedSc, University of Michigan

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, 2000

Primary Completion (Actual)

January 1, 2005

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

February 6, 2012

First Submitted That Met QC Criteria

February 8, 2012

First Posted (Estimate)

February 9, 2012

Study Record Updates

Last Update Posted (Estimate)

January 8, 2016

Last Update Submitted That Met QC Criteria

January 6, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005 - PDGF

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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