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

December 15, 2014 updated by: Virchow Group

Study on the Efficacy and Safety of PERIOGEN in the Treatment of Periodontal Bone Defect - A Double-blind, Controlled, Randomised,Parallel,Multi-centre Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Andhra pradesh
      • RR Dist, Andhra pradesh, India, 501101
        • Sri Sai Dental college of surgery, Vikarabad,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Drug Group
PERIOGEN
Drug: PERIOGEN
Implantation of rhPDGF-BB (0.3 mg/ml) + β-TCP (0.5 g)
Active Comparator: Control group
Beta TCP alone
Drug: Beta TCP alone
Implantation of β-TCP (0.5 g) alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: 6 months
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virchow Group

Investigators

  • Principal Investigator: A Jayakumar, MDS, Sri Sai Dental college of surgery, Vikarabad, RR Dist, AP, India.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

July 3, 2007

First Submitted That Met QC Criteria

July 3, 2007

First Posted (Estimate)

July 4, 2007

Study Record Updates

Last Update Posted (Estimate)

December 16, 2014

Last Update Submitted That Met QC Criteria

December 15, 2014

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • VB023/07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Intrabony Periodontal Defect

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe