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

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01530126
• Other study ID #: 2005 - PDGF
• Status: Completed
• Phase: N/A
• First received: February 6, 2012
• Last updated: January 6, 2016
• Start date: January 2000
• Est. completion date: January 2007

Study information

• Verified date: January 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: January 2007
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Periodontitis

Intervention

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

Locations

Country	Name	City	State
United States	University of Michigan School of Dentistry	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

References & 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 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of CAL Gain	Measurements for the rate of clinical attachment levels (CAL)	Baseline to 6 months	No
Secondary	Change in Gingival Recession (GR)	Measurements in changes of gingival recession (GR)	Baseline to 6 months	No