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

This study has been completed.
Sponsor:
Information provided by:
Virchow Group
ClinicalTrials.gov Identifier:
NCT00496847
First received: July 3, 2007
Last updated: November 23, 2009
Last verified: November 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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
Study Completion Date: August 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
India
Sri Sai Dental college of surgery, Vikarabad,
Rr Dist, Andhra pradesh, India, 501101
Sponsors and Collaborators
Virchow Group
Investigators
Principal Investigator: A Jayakumar, MDS Sri Sai Dental college of surgery, Vikarabad, RR Dist, AP, India.
  More Information

No publications provided by Virchow Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00496847     History of Changes
Other Study ID Numbers: VB023/07
Study First Received: July 3, 2007
Last Updated: November 23, 2009
Health Authority: India: Ministry of Health

Keywords provided by Virchow Group:
rhPDGF,
periodontal disease

ClinicalTrials.gov processed this record on October 16, 2014