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NCT Number: NCT00496847

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

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

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Key information

Conditions

Intrabony Periodontal Defect Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sri Sai Dental college of surgery, Vikarabad,

RR Dist, Andhra Pradesh, 501101, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PERIOGEN

Drug

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

Beta TCP alone

Drug

Implantation of β-TCP (0.5 g) alone

Primary outcomes

  1. 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.

    Time frame: 6 months

Secondary outcomes

  1. 1.Changes in CAL gain, probing depth and gingival recession at 3 and 6 months. 2.Incidence of adverse events.

    Time frame: 3 and 6 months

Sponsors and collaborators

Lead sponsor

Virchow Group

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Jul 4, 2007
Registry last updated
Dec 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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