Trial | NCT00496847  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    60
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
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.
Study Started
Aug 31
2007
Primary Completion
Aug 31
2008
Study Completion
Aug 31
2009
Last Update
Dec 16
2014
Estimate

Drug PERIOGEN

Implantation of rhPDGF-BB (0.3 mg/ml) + β-TCP (0.5 g)

Drug Beta TCP alone

Implantation of β-TCP (0.5 g) alone

Drug Group Experimental

PERIOGEN

Control group Active Comparator

Beta TCP alone

Criteria 

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.
No Results Posted