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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00496847

Enrollment

Registered

2007-07-04

Start date

2007-08-31

Completion date

2009-08-31

Last updated

2014-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrabony Periodontal Defect

Keywords

rhPDGF,, periodontal disease

Brief 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

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.

Interventions

DRUGPERIOGEN

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

DRUGBeta TCP alone

Implantation of β-TCP (0.5 g) alone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

25 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Secondary

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

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026