Periodontitis
Conditions
Keywords
periodontitis
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.
Interventions
BIOLOGICALB-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.
BIOLOGICALB-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.
BIOLOGICALB-TCP +buffer
B-TCP mixed with sodium acetate buffer and placed into osseous defect once at baseline visit.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of CAL Gain | Baseline to 6 months | Measurements for the rate of clinical attachment levels (CAL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gingival Recession (GR) | Baseline to 6 months | Measurements in changes of gingival recession (GR) |
Countries
United States
Outcome results
None listed