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CompletedNCT01530126Updated Jan 8, 2016

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

An interventional study of B-TCP + 0.3 mg/ml rhPDGF-BB in buffer and B-TCP + 1.0 mg/ml rhPDGF-BB in buffer in Periodontitis, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 25 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-01-08.

Sponsored by University of Michigan · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
25 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed description

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

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Conditions studied

  • Periodontitis

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Keywords

  • periodontitis
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In context

Periodontitis

1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.

This study's enrollment of 180 is above the median of 45 across 1,191 interventional studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
25 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
180 participants (actual)

Study arms

  • Active comparator
    B-TCP +buffer

    Administration of synthetic beta-tricalcium phosphate (B-TCP) mixed in sodium acetate buffer only.

    Biological: B-TCP +buffer

  • 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

  • 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

Interventions

  • BiologicalB-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.

  • BiologicalB-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.

  • BiologicalB-TCP +buffer

    B-TCP mixed with sodium acetate buffer and placed into osseous defect once at baseline visit.

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What researchers measure

Primary outcomes

  1. Rate of CAL Gain

    Measurements for the rate of clinical attachment levels (CAL)

    Time frame: Baseline to 6 months

Secondary outcomes

  1. Change in Gingival Recession (GR)

    Measurements in changes of gingival recession (GR)

    Time frame: Baseline to 6 months

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Study locations

1 site
  • University of Michigan School of Dentistry
    Ann Arbor, Michigan 48109, United States
08

References and documents

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. doi: 10.1902/jop.2005.76.12.2205. PubMed 16332231 ↗
  • 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. PubMed 22612364 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01530126
Lead sponsor
University of Michigan
Responsible party
William Giannobile (Principal Investigator, University of Michigan) — Principal investigator
First posted
Feb 9, 2012
Start date
Jan 2000
Primary completion
Jan 2005
Completion
Jan 2007
Last update
Jan 8, 2016

Study contacts

William Giannobile, DDS, DMedSc
principal investigator · University of Michigan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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