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OpenTrials
Completed

NCT Number: NCT01530126

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

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.

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Key information

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

B-TCP + 0.3 mg/ml rhPDGF-BB in buffer

Biological

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 + 1.0 mg/ml rhPDGF-BB in buffer

Biological

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 +buffer

Biological

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

Primary outcomes

  1. Rate of CAL Gain

    Time frame: Baseline to 6 months

    Measurements for the rate of clinical attachment levels (CAL)

Secondary outcomes

  1. Change in Gingival Recession (GR)

    Time frame: Baseline to 6 months

    Measurements in changes of gingival recession (GR)

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2000
Primary completion
2005
Study completion
2007
First posted
Feb 9, 2012
Registry last updated
Jan 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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