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CTRI Number  CTRI/2016/10/007339 [Registered on: 05/10/2016] Trial Registered Retrospectively
Last Modified On: 23/01/2016
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Relation between Vitamin d, Calcium and gum disease in the Bangalore population. 
Scientific Title of Study   Association between serum concentrations of Vitamin d3, calcium and chronic periodontitis in the Bangalore urban population. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrSushma Das  
Designation  READER 
Affiliation  The Oxford Dental College 
Address  Department of Periodontics, The Oxford Dental College Hosur Main road, Bommanahalli, Bangalore-560068
#209, 3rd avenue, 5th Main, Teachers colony, Koramangala I block, Bangalore-560034
Bangalore
KARNATAKA
560068
India 
Phone  9986726021  
Fax    
Email  drsushmadas@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  DrSushma Das  
Designation  READER 
Affiliation  The Oxford Dental College 
Address  Department of Periodontics, The Oxford Dental College Hosur Main road, Bommanahalli, Bangalore-560068
#209, 3rd avenue, 5th Main, Teachers colony, Koramangala I block, Bangalore-560034
Bangalore
KARNATAKA
560068
India 
Phone  9986726021  
Fax    
Email  drsushmadas@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  DrSushma Das  
Designation  READER 
Affiliation  The Oxford Dental College 
Address  Department of Periodontics, The Oxford Dental College Hosur Main road, Bommanahalli, Bangalore-560068
#209, 3rd avenue, 5th Main, Teachers colony, Koramangala I block, Bangalore-560034
Bangalore
KARNATAKA
560068
India 
Phone  9986726021  
Fax    
Email  drsushmadas@yahoo.co.in  
 
Source of Monetary or Material Support  
Rajiv Gandhi University of Health Sciences,4th T Block, Jayanagar, Bengaluru-560041 Karnataka 
 
Primary Sponsor  
Name  Rajiv Gandhi University of Health Sciences Karnataka 
Address  4th T Block, Jayanagar, Bengaluru, Karnataka 560041 
Type of Sponsor  Other [health science university] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  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 Sushma Das  The Oxford Dental College  10th Milestone, Hosur Rd, Bommanahalli, Bengaluru, Karnataka 560068
Bangalore
KARNATAKA 		 9986726021

drsushmadas@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IECTODC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Systemically healthy patients with chronic periodontitis 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age group 20-60 years.
Subjects should have at least 20 natural teeth.
Subjects diagnosed of chronic periodontitis.
Systemically healthy individuals.
Subjects who have not received periodontal therapy, within preceding six months.
 
 
ExclusionCriteria 
Details  Smokers and alcoholics.
Patients with Rheumatoid arthritis.
Patients with Diabetes mellitus.
Patients with liver disorders.
Any other systemic disease which can alter the course of periodontal disease.
Subjects should have not have recieved anti-inflammatory and antibiotic drugs in the previous 3 months 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Cross-sectional trial with no primary outcome  Serum samples will be collected at baseline after recording the periodontal clinical parameters 
 
Secondary Outcome  
Outcome  TimePoints 
Cross-sectional trial with no secondary outcome  No secondary outcome 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   N/A 
Date of First Enrollment (India)   08/02/2016 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Detention of human herpes viruses in patients with chronic and aggressive periodontitis and relationship between viruses and clinical parameters.Journal of oral and maxillofacial pathology. Vol. 16 issue 2 may – august 2012; 203 – 209 Application of ozone therapy in dentistry.Indian journal of dental advancements, 3(2), april – june, 2011  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary    This study aims to evaluate whether  Serum Vitamin D3 and calcium concentrations are associated with chronic periodontitis in bangalore urban population.
This cross sectional observational study consists of 4 groups with 25 patients in each group. Group1-female patients diagnosed with chronic periodontitis.
Group 2 includes healthy female volunteers, Group-3 with male patients diagnosed with Chronic periodontitis and group4 includes healthy male volunteers.Serum vitamin D and calcium concentrations will be tested in all the four groups. Clinical parameters includes recording of probing depth (PD), clinical attachment level (CAL), and bleeding on probing (BOP). Data will be collected and analyzed.


 
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