Study on the Efficacy and Safety of PERIOGEN in the Treatment of Periodontal Bone Defect - A Double-blind, Controlled, Randomised,Parallel,Multi-centre Study
Sponsor study identifier
interventional
60
1 country
1
Study Start
August 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2008
Actual (reported)Study Completion
August 2009
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 3, 2007
Actual (reported)July 4, 2007
Actual (reported)August 2007
Date type not reportedThis date has not been verified as actual or estimated.
August 2008
Actual (reported)August 2009
Actual (reported)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
1.Changes in CAL gain, probing depth and gingival recession at 3 and 6 months. 2.Incidence of adverse events.
3 and 6 months
PERIOGEN
Beta TCP alone
Implantation of rhPDGF-BB (0.3 mg/ml) + β-TCP (0.5 g)
Implantation of β-TCP (0.5 g) alone
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Sri Sai Dental college of surgery, Vikarabad,
RR Dist, Andhra Pradesh, 501101, India
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.
A Jayakumar, MDS
Sri Sai Dental college of surgery, Vikarabad, RR Dist, AP, India.
60 participants (actual enrollment reported by the registry).
First Submitted
July 3, 2007
First Posted
July 4, 2007
Study Start
August 2007
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
August 2008
Actual (reported)Study Completion
August 2009
Actual (reported)Last Updated
December 16, 2014
Record last verified: 2009-11
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Source: ClinicalTrials.gov.
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