Platelet Derived Growth Factor Stimulates Bone Fill and Rate of Attachment Level Gain
1 other identifier
interventional
180
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2000
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 6, 2012
CompletedFirst Posted
Study publicly available on registry
February 9, 2012
CompletedJanuary 8, 2016
January 1, 2016
5 years
February 6, 2012
January 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of CAL Gain
Measurements for the rate of clinical attachment levels (CAL)
Baseline to 6 months
Secondary Outcomes (1)
Change in Gingival Recession (GR)
Baseline to 6 months
Study Arms (3)
B-TCP +buffer
ACTIVE COMPARATORAdministration of synthetic beta-tricalcium phosphate (B-TCP) mixed in sodium acetate buffer only.
B-TCP + 0.3 mg/ml rhPDGF-BB in buffer
EXPERIMENTALAdministration 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.
B-TCP + 1.0 mg/ml rhPDGF-BB in buffer
EXPERIMENTALAdministration 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.
Interventions
B-TCP mixed with sodium acetate buffer and 0.3 mg/ml rhPDGF-BB and placed into osseous defect once at baseline visit.
B-TCP mixed with sodium acetate buffer and 1.0 mg/ml rhPDGF-BB and placed into osseous defect once at baseline visit.
B-TCP mixed with sodium acetate buffer and placed into osseous defect once at baseline visit.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan School of Dentistry
Ann Arbor, Michigan, 48109, United States
Related Publications (2)
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. doi: 10.1902/jop.2005.76.12.2205.
PMID: 16332231RESULTNevins 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.
PMID: 22612364RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William Giannobile, DDS, DMedSc
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 6, 2012
First Posted
February 9, 2012
Study Start
January 1, 2000
Primary Completion
January 1, 2005
Study Completion
January 1, 2007
Last Updated
January 8, 2016
Record last verified: 2016-01