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CTRI Number  CTRI/2020/10/028658 [Registered on: 27/10/2020] Trial Registered Prospectively
Last Modified On: 24/10/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Comparing Kidodent mouthwash with coriander seed oil mouth wash in reducing oral bacteria count 
Scientific Title of Study   A Comparative Evaluation of Antibacterial efficacy Kidodent Mouthwash and Coriandrum Sativum oil mouthwash in reducing Salivary Streptococcus mutans count -A Randomized Controlled Study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Badar Omera Fatima 
Designation  Post graduate Student (MDS) 
Affiliation  A M Es Dental College 
Address  A M Es Dental College Hospital and Research centre Near polytechnic college Bijjenegera Road Raichur Raichur KARNATAKA 584103 India
A M Es Dental College Hospital and Research centre Near polytechnic college Bijjenegera Road Raichur Raichur KARNATAKA 584103 India
Raichur
KARNATAKA
584103
India 
Phone  7330658540  
Fax    
Email  omerafatima93@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dhanu G Rao 
Designation  Head of the Department 
Affiliation  A M Es Dental College 
Address  A M Es Dental College Hospital and Research centre Near polytechnic college Bijjenegera Road Raichur Raichur KARNATAKA 584103 India
A M Es Dental College Hospital and Research centre Near polytechnic college Bijjenegera Road Raichur Raichur KARNATAKA 584103 India
Raichur
KARNATAKA
584103
India 
Phone  7330658540  
Fax    
Email  drdhanu74@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Badar Omera Fatima 
Designation  Post graduate Student (MDS) 
Affiliation  A M Es Dental College 
Address  A M Es Dental College Hospital and Research centre Near polytechnic college Bijjenegera Road Raichur Raichur KARNATAKA 584103 India
A M Es Dental College Hospital and Research centre Near polytechnic college Bijjenegera Road Raichur Raichur KARNATAKA 584103 India
Raichur
KARNATAKA
584103
India 
Phone  7330658540  
Fax    
Email  omerafatima93@gmail.com  
 
Source of Monetary or Material Support  
A M E Dental College and Hospital, Bijanagera road,Raichur, Karnataka 
 
Primary Sponsor  
Name  Badar Omera Fatima 
Address  A M Es Dental College and Hospital Bijjanegera Road Raichur 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Dhanu G Rao  A M Es Dental College and Hospital Bijjanegera Road Raichur 
Dr Raghavendra Havale  A M Es Dental College and Hospital Bijjanegera Road Raichur 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Badar Omera Fatima  Morarji Desai Residential School Class VI and VII  Morarji Desai Residential School Bolamanadoddi Road Vidyanagr I & II Phase Raichur. Raichur KARNATAKA
Raichur
KARNATAKA 		 7330658540

omerafatima93@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe of A M Es Dental College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Volunteers of age group 8-12 years and No abnormality detected 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Coriandrum Sativum seed oil Mouthwash  10ml OD, Oral rinse for 15 days 
Comparator Agent  Kidodent Mouthwash  10ml OD, Oral rinse for 15days 
Comparator Agent  Placebo  10ml OD, Oral rinse for 15days 
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1) Children with good general health,
2) Children devoid of infectious diseases. 
 
ExclusionCriteria 
Details  1) Children who cannot expectorate completely, 2) History of taking
antibiotics one month before and amidst clinical trial,
3) Children receiving orthodontic treatment or with any kind of oral prosthesis,
4) Presence of any intra oral pathology,
5) Children not available for follow up phase and children who are
using any oral hygiene aids. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
to evalute the antibacterial efficacy of coriander seed oil mouthwash and Kidodent mouthwash against Streptococcus mutans.   Baseline, 7th day, 10th day and 15th day 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of Coriandrum Sativum seed oil mouthwash
in reduction of Streptococcus mutans level over
the period of 15 days. 		 Baseline, 7th day, 10th day and 15th day 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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)   30/10/2020 
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="0"
Days="20" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not Published 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   After approval from institutional review board and institutional informed consent, 45 children who met the inclusion criteria will be divided into three groups .The trial design  includes 15 healthy children in each group namely Group I(Kidodent), Group II(Coriander) & Group III(Distilled water) aged between 8-12years for 15 days.   Microbiological analysis will be performed using saliva samples of all the participants at baseline, 7th day, 10 th day and 15th day Statistical analysis will be performed with one-way ANOVA and t-test using Graph Pad Prism V.5 software. 
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