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

Intrabony Periodontal Defect Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00496847
• Other study ID #: VB023/07
• Status: Completed
• Phase: Phase 3
• First received: July 3, 2007
• Last updated: December 15, 2014
• Start date: August 2007
• Est. completion date: August 2009

Study information

• Verified date: November 2009
• Source: Virchow Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2009
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intrabony Periodontal Defect

Intervention

Drug:
• PERIOGEN
Implantation of rhPDGF-BB (0.3 mg/ml) + ß-TCP (0.5 g)
• Beta TCP alone
Implantation of ß-TCP (0.5 g) alone

Locations

Country	Name	City	State
India	Sri Sai Dental college of surgery, Vikarabad,	RR Dist	Andhra pradesh

Sponsors (1)

Lead Sponsor	Collaborator
Virchow Group

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		6 months	Yes
Secondary	1.Changes in CAL gain, probing depth and gingival recession at 3 and 6 months. 2.Incidence of adverse events.		3 and 6 months	Yes