Clinical trial NCT01530126: 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
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Keywords: periodontitis
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2012-02-09
Enrollment: 180
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Rate of CAL Gain
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Change in Gingival Recession (GR)
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan School of Dentistry
state: Michigan
Study officials:
affiliation: University of Michigan
name: William Giannobile, DDS, DMedSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.