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

This study is not yet open for participant recruitment.
Verified by Virchow Group, July 2007

Sponsored by: Virchow Group
Information provided by: Virchow Group
ClinicalTrials.gov Identifier: NCT00496847
  Purpose

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


Condition Intervention Phase
Periodontal Defects
Drug: PERIOGEN (rhPDGF-beta-TCP)
Phase III

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official 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

Further study details as provided by Virchow Group:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Estimated Enrollment:   60
Study Start Date:   August 2007
Estimated Study Completion Date:   September 2008

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  1. Probing depth ≥7 mm at baseline
  2. Presence of ≥4 mm vertical bone defect with at least 1 bony wall after surgical debridement.
  3. Adequate keratinized tissue to permit complete tissue coverage of defect.
  4. Radiographic base of defect ≥3 mm coronal to the apex of the tooth.

Exclusion Criteria:

  1. Failure to maintain adequate oral hygiene (plaque index>2)
  2. Pregnant and lactating women
  3. History of oral cancer or HIV
  4. Periodontal surgery on treatment-targeted tooth within the last year.
  5. Tooth mobility greater than grade II.
  6. Study tooth exhibiting a class III furacation defect
  7. Localized aggressive periodontitis
  8. Radiographic signs of untreated acute infection at the surgical site
  9. Recent history of smoking more than 20 cigarettes/day
  10. Known allergy to E.coli-derived products
  11. Using an investigational therapy within the past 30 days.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00496847

Contacts
Contact: Hemanth Nandigala, MBBS     91+4023800924 ext 23     hemanth@virchows.com    
Contact: TC Raghuram, MD, PhD     91+4023800924 ext 28     tcraghuram@yahoo.com    

Locations
India, Andhra pradesh
Sri Sai Dental college of surgery, Vikarabad,     Not yet recruiting
      RR Dist, Andhra pradesh, India, 501101
      Principal Investigator: A Jayakumar, MDS            

Sponsors and Collaborators
Virchow Group

Investigators
Principal Investigator:     A Jayakumar, MDS     Sri Sai Dental college of surgery, Vikarabad, RR Dist, AP, India.    
  More Information


Study ID Numbers:   VB023/07
First Received:   July 3, 2007
Last Updated:   July 13, 2007
ClinicalTrials.gov Identifier:   NCT00496847
Health Authority:   India: Ministry of Health

Keywords provided by Virchow Group:
rhPDGF,  
periodontal disease  

Study placed in the following topic categories:
Periodontal Diseases

ClinicalTrials.gov processed this record on October 06, 2008




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