Efficacy and Safety of PERIOGEN in the Treatment of Periodontal Bone Defect
NCT ID: NCT00496847
Last Updated: 2014-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
60 participants
INTERVENTIONAL
2007-08-31
2009-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Drug Group
PERIOGEN
PERIOGEN
Implantation of rhPDGF-BB (0.3 mg/ml) + β-TCP (0.5 g)
Control group
Beta TCP alone
Beta TCP alone
Implantation of β-TCP (0.5 g) alone
Interventions
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PERIOGEN
Implantation of rhPDGF-BB (0.3 mg/ml) + β-TCP (0.5 g)
Beta TCP alone
Implantation of β-TCP (0.5 g) alone
Eligibility Criteria
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Inclusion Criteria
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
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.
25 Years
75 Years
ALL
No
Sponsors
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Virchow Group
INDUSTRY
Responsible Party
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Principal Investigators
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A Jayakumar, MDS
Role: PRINCIPAL_INVESTIGATOR
Sri Sai Dental college of surgery, Vikarabad, RR Dist, AP, India.
Locations
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Sri Sai Dental college of surgery, Vikarabad,
RR Dist, Andhra Pradesh, India
Countries
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References
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Jayakumar A, Rajababu P, Rohini S, Butchibabu K, Naveen A, Reddy PK, Vidyasagar S, Satyanarayana D, Pavan Kumar S. Multi-centre, randomized clinical trial on the efficacy and safety of recombinant human platelet-derived growth factor with beta-tricalcium phosphate in human intra-osseous periodontal defects. J Clin Periodontol. 2011 Feb;38(2):163-72. doi: 10.1111/j.1600-051X.2010.01639.x. Epub 2010 Dec 6.
Other Identifiers
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VB023/07
Identifier Type: -
Identifier Source: org_study_id