A clinical trial to study the efficacy of PERIOGEN (rhPDGF-beta-TCP) in comparison to beta TCP in patients with dental defects.
- Conditions
- Health Condition 1: K06- Other disorders of gingiva and edentulous alveolar ridge
- Registration Number
- CTRI/2008/091/000152
- Lead Sponsor
- Virchow Biotech Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 54
1.Probing depth greater than or equal to 7 mm at baseline
2.Presence of greater than or equal to4 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 greater than or equal to 3 mm coronal to the apex of the tooth.
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
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method