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

Phase 3

Completed

• Conditions: Intrabony Periodontal Defect
• Interventions: Drug: PERIOGEN; Drug: Beta TCP alone

• Registration Number: NCT00496847
• Lead Sponsor: Virchow Group

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.

Study Timeline

• Study First Submitted: 2007-07-03
• Study First Submitted QC: 2007-07-03
• Study First Posted: 2007-07-04
• Study Start: 2007-08
• Primary Completion: 2008-08
• Study Completion: 2009-08
• Status Verified: 2009-11
• Last Update Submitted: 2014-12-15
• Last Update Posted: 2014-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug Group	PERIOGEN	PERIOGEN
Control group	Beta TCP alone	Beta TCP alone

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Sri Sai Dental college of surgery, Vikarabad,; 🇮🇳 RR Dist, Andhra pradesh, India