Efficacy and Safety of PERIOGEN in the Treatment of Periodontal Bone Defect

Study Overview
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Brief Summary
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PERIOGEN, containing rhPDGF and -beta-TCP, promotes gingival healing and corrects periodontal defects. This study will test the safety and efficacy of PERIOGEN in the treatment of periodontal disease

Detailed Description
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Sixty eligible patients with periodontal defect will randomly receive either beta-TCP implantation (control group) or PERIOGEN implantation, containing beta-TCP and rhPDGF (drug group). The specified primary and secondary end points related to efficacy and safety will be assessed during 6 months study period.

Official Title
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Study on the Efficacy and Safety of PERIOGEN in the Treatment of Periodontal Bone Defect - A Double-blind, Controlled, Randomised,Parallel,Multi-centre Study

Conditions
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Intrabony Periodontal Defect

Intervention / Treatment
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* Drug: PERIOGEN
* Drug: Beta TCP alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Probing depth ≥7 mm at baseline Presence of ≥4 mm vertical bone defect with at least 1 bony wall after surgical debridement. Adequate keratinized tissue to permit complete tissue coverage of defect. Radiographic base of defect ≥3 mm coronal to the apex of the tooth. Exclusion Criteria: Failure to maintain adequate oral hygiene (plaque index>2) Pregnant and lactating women History of oral cancer or HIV Periodontal surgery on treatment-targeted tooth within the last year. Tooth mobility greater than grade II. Study tooth exhibiting a class III furacation defect Localized aggressive periodontitis Radiographic signs of untreated acute infection at the surgical site Recent history of smoking more than 20 cigarettes/day Known allergy to E.coli-derived products Using an investigational therapy within the past 30 days.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug Group<br>PERIOGEN | Drug: PERIOGEN<br>* Implantation of rhPDGF-BB (0.3 mg/ml) + β-TCP (0.5 g)<br>|
| Active Comparator: Control group<br>Beta TCP alone | Drug: Beta TCP alone<br>* Implantation of β-TCP (0.5 g) alone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1.Area under curve (AUC) of clinical attachment level (CAL) gain (0-24 weeks) 2.Extent of linear bone growth (LBG) and percentage of bone fill (%BF) at 6 months. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1.Changes in CAL gain, probing depth and gingival recession at 3 and 6 months. 2.Incidence of adverse events. |  | 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rhPDGF,, periodontal disease