Efficacy and Safety of PERIOGEN in the Treatment of Perio... | NCT00496847

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

NCT00496847

Sponsor

Virchow Group

Status

Completed

Last Update Posted

Dec 16, 2014Estimated

Enrollment

60Actual

Phase

Phase 3

Conditions

Intrabony Periodontal Defect

Interventions

PERIOGEN
Beta TCP alone

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Aug 2008Actual

Completion Date

Aug 2009Actual

First Submitted Date

Jul 3, 2007

First Submission Date that Met QC Criteria

Jul 3, 2007

First Posted Date

Jul 4, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 15, 2014

Last Update Posted Date

Dec 16, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Drug Group	Experimental	PERIOGEN	Drug: PERIOGEN
Control group	Active Comparator	Beta TCP alone	Drug: Beta TCP alone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PERIOGEN	Drug	Implantation of rhPDGF-BB (0.3 mg/ml) + β-TCP (0.5 g)	Drug Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Probing depth ≥7 mm at baseline
Presence of ≥4 mm vertical bone defect with at least 1 bony wall after surgical debridement.
Adequate keratinized tissue to permit complete tissue coverage of defect.
Radiographic base of defect ≥3 mm coronal to the apex of the tooth.

Exclusion Criteria:

Failure to maintain adequate oral hygiene (plaque index>2)
Pregnant and lactating women
History of oral cancer or HIV
Periodontal surgery on treatment-targeted tooth within the last year.
Tooth mobility greater than grade II.
Study tooth exhibiting a class III furacation defect
Localized aggressive periodontitis
Radiographic signs of untreated acute infection at the surgical site
Recent history of smoking more than 20 cigarettes/day
Known allergy to E.coli-derived products
Using an investigational therapy within the past 30 days.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
A Jayakumar, MDS	Sri Sai Dental college of surgery, Vikarabad, RR Dist, AP, India.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sri Sai Dental college of surgery, Vikarabad,		RR Dist	Andhra Pradesh	501101	India

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21133980	Derived	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.

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases