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

Virchow Group

Status and phase: Completed; Phase 3

Conditions: Intrabony Periodontal Defect

Treatments: Drug: PERIOGEN; Drug: Beta TCP alone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00496847

VB023/07

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 25 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

60 participants in 2 patient groups

Drug Group

Experimental group

Description:

PERIOGEN

Treatment:

Drug: PERIOGEN

Control group

Active Comparator group

Description:

Beta TCP alone

Treatment:

Drug: Beta TCP alone