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

Primary Purpose

Periodontitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
B-TCP + 0.3 mg/ml rhPDGF-BB in buffer
B-TCP + 1.0 mg/ml rhPDGF-BB in buffer
B-TCP +buffer
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring periodontitis

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan School of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

B-TCP +buffer

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

B-TCP + 1.0 mg/ml rhPDGF-BB in buffer

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

Rate of CAL Gain
Measurements for the rate of clinical attachment levels (CAL)

Secondary Outcome Measures

Change in Gingival Recession (GR)
Measurements in changes of gingival recession (GR)

Full Information

First Posted
February 6, 2012
Last Updated
January 6, 2016
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT01530126
Brief Title
Platelet Derived Growth Factor Stimulates Bone Fill and Rate of Attachment Level Gain
Official Title
Platelet Derived Growth Factor Stimulates Bone Fill and Rate of Attachment Level Gain
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
B-TCP +buffer
Arm Type
Active Comparator
Arm Description
Administration of synthetic beta-tricalcium phosphate (B-TCP) mixed in sodium acetate buffer only.
Arm Title
B-TCP + 0.3 mg/ml rhPDGF-BB in buffer
Arm Type
Experimental
Arm Description
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.
Arm Title
B-TCP + 1.0 mg/ml rhPDGF-BB in buffer
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
B-TCP + 0.3 mg/ml rhPDGF-BB in buffer
Intervention Description
B-TCP mixed with sodium acetate buffer and 0.3 mg/ml rhPDGF-BB and placed into osseous defect once at baseline visit.
Intervention Type
Biological
Intervention Name(s)
B-TCP + 1.0 mg/ml rhPDGF-BB in buffer
Intervention Description
B-TCP mixed with sodium acetate buffer and 1.0 mg/ml rhPDGF-BB and placed into osseous defect once at baseline visit.
Intervention Type
Biological
Intervention Name(s)
B-TCP +buffer
Intervention Description
B-TCP mixed with sodium acetate buffer and placed into osseous defect once at baseline visit.
Primary Outcome Measure Information:
Title
Rate of CAL Gain
Description
Measurements for the rate of clinical attachment levels (CAL)
Time Frame
Baseline to 6 months
Secondary Outcome Measure Information:
Title
Change in Gingival Recession (GR)
Description
Measurements in changes of gingival recession (GR)
Time Frame
Baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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, 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Giannobile, DDS, DMedSc
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan School of Dentistry
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16332231
Citation
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.
Results Reference
result
PubMed Identifier
22612364
Citation
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.
Results Reference
result

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

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