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

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

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

Conditions
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Periodontitis

Intervention / Treatment
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* Biological: B-TCP + 0.3 mg/ml rhPDGF-BB in buffer
* Biological: B-TCP + 1.0 mg/ml rhPDGF-BB in buffer
* Biological: B-TCP +buffer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: B-TCP +buffer<br>Administration of synthetic beta-tricalcium phosphate (B-TCP) mixed in sodium acetate buffer only. | Biological: B-TCP +buffer<br>* B-TCP mixed with sodium acetate buffer and placed into osseous defect once at baseline visit.<br>|
| Experimental: B-TCP + 0.3 mg/ml rhPDGF-BB in buffer<br>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. | Biological: B-TCP + 0.3 mg/ml rhPDGF-BB in buffer<br>* B-TCP mixed with sodium acetate buffer and 0.3 mg/ml rhPDGF-BB and placed into osseous defect once at baseline visit.<br>|
| Experimental: B-TCP + 1.0 mg/ml rhPDGF-BB in buffer<br>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. | Biological: B-TCP + 1.0 mg/ml rhPDGF-BB in buffer<br>* B-TCP mixed with sodium acetate buffer and 1.0 mg/ml rhPDGF-BB and placed into osseous defect once at baseline visit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of CAL Gain | Measurements for the rate of clinical attachment levels (CAL) | Baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Gingival Recession (GR) | Measurements in changes of gingival recession (GR) | Baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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periodontitis