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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
William Giannobile, University of Michigan
ClinicalTrials.gov Identifier:
NCT01530126
First received: February 6, 2012
Last updated: February 8, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Periodontitis
Biological: B-TCP + 0.3 mg/ml rhPDGF-BB in buffer
Biological: Experimental: B-TCP + 1.0 mg/ml rhPDGF-BB in buffer
Drug: B-TCP +buffer

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Platelet Derived Growth Factor Stimulates Bone Fill and Rate of Attachment Level Gain

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Rate of Cal Gain [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction in gingival recession [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]

Enrollment: 180
Study Start Date: January 2000
Study Completion Date: January 2007
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: B-TCP +buffer Drug: 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 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 Biological: Experimental: 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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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, rooth fracture, severe root irregularities, cemental pearls, 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01530126

Locations
United States, Michigan
University of Michigan School of Dentistry
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: William Giannobile, DDS, DMedSc University of Michigan
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: William Giannobile, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01530126     History of Changes
Other Study ID Numbers: 2005 - PDGF
Study First Received: February 6, 2012
Last Updated: February 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
periodontitis

Additional relevant MeSH terms:
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Mitogens
Platelet-derived growth factor BB
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Angiogenesis Inducing Agents
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014