Efficacy and Safety of PERIOGEN in the Treatment of Periodontal Bone Defect
This study has been completed.
Sponsor:
Virchow Group
Information provided by:
Virchow Group
ClinicalTrials.gov Identifier:
NCT00496847
First received: July 3, 2007
Last updated: November 23, 2009
Last verified: November 2009
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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) |
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:
- 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.
Contacts and Locations
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 May 19, 2013