Platelet Derived Growth Factor Stimulates Bone Fill and Rate of Attachment Level Gain - Full Text View

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:

Drug Information available for: Becaplermin

U.S. FDA Resources

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

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:

Nevins M, Giannobile WV, McGuire MK, Kao RT, Mellonig JT, Hinrichs JE, McAllister BS, Murphy KS, McClain PK, Nevins ML, Paquette DW, Han TJ, Reddy MS, Lavin PT, Genco RJ, Lynch SE. Platelet-derived growth factor stimulates bone fill and rate of attachment level gain: results of a large multicenter randomized controlled trial. J Periodontol. 2005 Dec;76(12):2205-15.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Nevins M, Kao RT, McGuire MK, McClain PK, Hinrichs JE, McAllister BS, Reddy MS, Nevins ML, Genco RJ, Lynch SE, Giannobile WV. Platelet-derived growth factor promotes periodontal regeneration in localized osseous defects: 36-month extension results from a randomized, controlled, double-masked clinical trial. J Periodontol. 2013 Apr;84(4):456-64. doi: 10.1902/jop.2012.120141. Epub 2012 May 21.

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 May 16, 2013