| CTRI Number |
CTRI/2008/091/000152 [Registered on: 30/11/2009] |
| Last Modified On: |
20/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical trial to study the efficacy of PERIOGEN (rhPDGF-beta-TCP) in comparison to beta TCP in patients with dental defects. |
Scientific Title of Study
Modification(s)
|
Study on the efficacy and safety of PERIOGEN (rhPDGF-beta-TCP) in the treatment of periodontal bone defect - A double-blind, controlled, randomized, parallel multi-centre study |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NCT00496847 |
ClinicalTrials.gov |
| VB 023/2006 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
A Jayakumar MDS |
| Designation |
|
| Affiliation |
|
| Address |
Sri Sai Dental college of surgery
RR Dist
Not Applicable
N/A
501101
India |
| Phone |
09848032097 |
| Fax |
|
| Email |
avulajk@rediffmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Hemanth |
| Designation |
|
| Affiliation |
Executive Director (Comm.) |
| Address |
Virchow Biotech Pvt Ltd
Hyderabad
Hyderabad
ANDHRA PRADESH
500 018
India |
| Phone |
04023800924 |
| Fax |
04023800925 |
| Email |
hemanth@virchows.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Hemanth |
| Designation |
|
| Affiliation |
|
| Address |
Virchow Biotech Pvt Ltd, Flat No.: 101 & 102, Ram?s Enclave, Erragadda,
Flat No.: 101 & 102, Ram?s Enclave
Hyderabad
ANDHRA PRADESH
500 018
India |
| Phone |
04023800924 |
| Fax |
04023800925 |
| Email |
hemanth@virchows.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Virchow Biotech Private Limited |
|
Primary Sponsor
Modification(s)
|
| Name |
Virchow Biotech Pvt Ltd |
| Address |
Hyderabad |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr A Jayakumar |
1. Sri Sai Dental college of surgery |
Vikarabad,RR Dist
|
09848032097
avulajk@hotmail.com |
| Dr. P. Raja Babu |
Kamineni Institute of Dental Sciences |
Sree puram, Narketpally,Nalgonda Dist-
Nalgonda
ANDHRA PRADESH |
|
| Dr K Butchibabu |
Smilie Dental Hospital |
Vanasthalipuram,
Hyderabad
Hyderabad
ANDHRA PRADESH |
04024151066
docbutchi@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Maxivision |
Approved |
| Institutional Ethics Committee of Kamineni Educational Society |
Approved |
| Sri Sai College of Dental Surgery Ethical Committee |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K06||Other disorders of gingiva and edentulous alveolar ridge, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
betaTCP |
0.5 cc beta TCP is implanted |
| Intervention |
PERIOGEN (rhPDGF-beta-TCP) |
Periogen containing 0.3 mg/ml of rhPDGF and 0.5 cc β-TCP is implanted |
|
Inclusion Criteria
Modification(s)
|
| Age From |
25.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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.
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Centralized |
Blinding/Masking
Modification(s)
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
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.
|
1. AUC from 0 to 24 weeks
2. LBG at 6 months |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| 1. Changes in CAL gain, probing depth and gingival recession at 3 and 6 months; 2.Incidence of adverse events |
1. CAL gain, probing depth and gingival recession at 3 and 6 months
2. During the entire study period of 6 months |
|
Target Sample Size
Modification(s)
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "54"
Final Enrollment numbers achieved (India)="54" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
24/11/2007 |
| Date of Study Completion (India) |
17/07/2009 |
| Date of First Enrollment (Global) |
24/11/2007 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
J Clin Periodontol
2011; 38: 163–172 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a double-blind, controlled, randomised, parallel, multi-centre study. 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. |