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CTRI Number  CTRI/2008/091/000285 [Registered on: 17/12/2008]
Last Modified On:
Post Graduate Thesis   
Type of Trial   
Type of Study    
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the advantage of using concentrated autologous platelets along with a bioactive composite in the treatment of periodontal defects 
Scientific Title of Study   Clinical Evaluation of Bioactive Composite (Chitra-HABG) along with Concentrated Autologous Platelets in the Treatment of Periodontal Defects 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. K.Nandakumar 
Designation   
Affiliation   
Address  Principal & Head of the Dept of Periodontics
Azeezia College of Dental Sciences and Research
Not Applicable
N/A
691537
India 
Phone  9447066100  
Fax    
Email  drknandakumar@vsnl.net  
 
Details of Contact Person
Scientific Query  
Name  Dr. K.Nandakumar 
Designation   
Affiliation  Principal Investigator 
Address  Principal & Head of the Dept of Periodontics
Azeezia College of Dental Sciences and Research
Not Applicable
N/A
691537
India 
Phone  9447066100  
Fax    
Email  drknandakumar@vsnl.net  
 
Details of Contact Person
Public Query  
Name  Dr. Harikrishna Varma P.R.  
Designation   
Affiliation   
Address  Scientist-in-Charge, Bioceramics Lab
Biomedical Technology Wing, SCTIMST
Not Applicable
N/A
695012
India 
Phone  (0471) 2520220  
Fax    
Email  varma@sctimst.ac.in  
 
Source of Monetary or Material Support  
Internal (from Institutions involved in the study) 
 
Primary Sponsor  
Name  Sree Chitra Tirunal Institute of Medical Science and Technology, Thiruvananthapuram- 692012, Kerala 
Address   
Type of Sponsor   
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr. K.Nandakumar  Azeezia College of Dental Sciences and Research  Meeyyannoor ,-691537
Kollam
KERALA 		 0471 2459235

drknandakumar@vsnl.net 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, Sree Chitra Tirunal Institute for Medical Science and Technology  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Healing of periodontal defects arising out of chronic peridotitis.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Periodontal surgery  Open flap debridement alone 
Intervention  Periodontal surgery  Open-flap debridement and grafting 
 
Inclusion Criteria  
Age From   
Age To   
Gender   
Details  1. Patients with normal health and with no complicating medical history that would contra-indicate routine periodontal surgery. 2. Patient age between 35and 44 years. 3. Presence of two or more sites in different quadrants with probing pocket depth ranging between 5 - 10 mm. The sites should exhibit clinical and radiographic evidence of intrabony defects. 4. Defects at balanced sites so that one could be used as control. 5. No history of allergy to any systemic analgesics or antibiotics.  
 
ExclusionCriteria 
Details  1. Patients with systemic diseases. 2. Pregnant and lactating women. 3. Smokers and those with the habit of using tobacco. 4. Patients on anti-platelet drugs.  
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Soft tissue parameters 1.Probing pocket depth. 2. Gingival margin level 3. Clinical attachment level   Immediate Pre-operative, 1 month, 3 months, 6 months, 9 months and 12 months  
 
Secondary Outcome  
Outcome  TimePoints 
Digital IOPA radiograpgh  Immediate Pre-operative, 1 month, 3 months, 6 months, 9 months and 12 months  
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  06/01/2009 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years=""
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)   
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   The proposed study is on the efficacy of surgical grafting of periodontal defects when autologous platelet concentate is used along with a bioactive composite graft. A total of 40 subjects, who voluntarily consent to participate, will be recruited. There will be 2 treatment groups (as below), wherein each group will have 20 treatment sites and 20 control sites. In the first group, graft material (Chitra-HABG, the Bioactive Composite Granules developed at SCTIMST) will be placed in the periodontal defect. Balanced control sites will be identified in the same patient in which, the conventional open-flap debridement will be given. In the second group, the graft material (Chitra-HABG, the Bioactive Composite Granules) mixed with autologous platelets isolated through the CAPS Platelet Isolation Kit will be placed. As in the first group, balanced control sites will be identified in the same patient in which, the conventional open-flap debridement will be given. The safety and efficacy of the grafts will be assessed through clinical and radiographic methods.  
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