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

Not Applicable

Completed

• Conditions: Periodontitis
• Interventions: Biological: B-TCP +buffer; Biological: B-TCP + 1.0 mg/ml rhPDGF-BB in buffer; Biological: B-TCP + 0.3 mg/ml rhPDGF-BB in buffer

• Registration Number: NCT01530126
• Lead Sponsor: University of Michigan

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2000-01
• Primary Completion: 2005-01
• Study Completion: 2007-01
• Study First Submitted: 2012-02-06
• Study First Submitted QC: 2012-02-08
• Study First Posted: 2012-02-09
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-06
• Last Update Posted: 2016-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

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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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B-TCP +buffer	B-TCP +buffer	Administration of synthetic beta-tricalcium phosphate (B-TCP) mixed in sodium acetate buffer only.
B-TCP + 1.0 mg/ml rhPDGF-BB in buffer	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.
B-TCP + 0.3 mg/ml rhPDGF-BB in buffer	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.

Primary Outcome Measures

Name	Time	Method
Rate of CAL Gain	Baseline to 6 months	Measurements for the rate of clinical attachment levels (CAL)

Secondary Outcome Measures

Name	Time	Method
Change in Gingival Recession (GR)	Baseline to 6 months	Measurements in changes of gingival recession (GR)

Trial Locations

Locations (1)

University of Michigan School of Dentistry; 🇺🇸 Ann Arbor, Michigan, United States