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CTRI Number  CTRI/2020/10/028594 [Registered on: 23/10/2020] Trial Registered Prospectively
Last Modified On: 22/10/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Preventive
Dentistry
Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparision of Rice husk extract mouthwash and Kidodent mouthwash in children 
Scientific Title of Study   A Comparative Evaluation of Antibacterial efficacy of Rice Husk Extract Mouthwash and Kidodent Mouthwash in reducing Salivary Streptococcus mutans count – A Randomised 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  Dr B Neha 
Designation  Post graduate Student MDS 
Affiliation  A M E Dental College Hospital and Research Centre 
Address  A M E Dental College Hospital and Research centre Near polytechnic college Bijjenegera Road Raichur

Raichur
KARNATAKA
584103
India 
Phone  7989966383  
Fax    
Email  shreya.bemalgi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Dhanu Rao 
Designation  MDS 
Affiliation  A M Es Dental College Hospital and Research centre 
Address  A M Es Dental College Hospital and Research centre Near polytechnic college Bijjenegera Road Raichur

Raichur
KARNATAKA
584103
India 
Phone  9845031755  
Fax    
Email  drdhanu74@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Raghavendra Havale 
Designation  MDS 
Affiliation  A M Es Dental college hospital and research centre 
Address  A M Es Dental College Hospital and Research centre Near polytechnic college Bijjenegera Road Raichur

Raichur
KARNATAKA
584103
India 
Phone  944807300  
Fax    
Email  raghavendrahavale@yahoo.co.in  
 
Source of Monetary or Material Support  
A M Es Dental College and Hospital Bijjanegera Road Raichur 
 
Primary Sponsor  
Name  Dr B Neha 
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 
Dr B Neha  Morarji Desai Residential School  Morarji Desai Residential School Bolamanadoddi Road Vidyanagr I & II Phase Raichur.
Raichur
KARNATAKA 
7989966383

shreya.bemalgi@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 
Comparator Agent  Kidodent Mouthwash  10ml OD, Oral rinse for 15days. 
Comparator Agent  Placebo group  10ml OD, Oral rinse for 15days 
Intervention  Rice husk extract mouthwash  10ml OD, Oral rinse for 15 days 
 
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   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of rice husk mouthwash in comparision to Kidodent mouthwash in reduction of Streptococcus mutans level  Baseline, 7th day, 10th day and 15th day 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluate for any malodour after the use of rice husk mouthwash  Everyday throughout the study period 
To evaluate the efficacy of rice husk 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)   25/10/2020 
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/ Not applicable 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Background: Dental Caries is attributed to the Streptococcus mutans in the oral cavity. Rice husk is the byproduct of rice milling it is of great benefit to both the economy and environment to effectively convert rice husk into valuable products. The presence of antioxidant activity, phenolic compounds, flavonoid contents, gamma-oryzanols, and tocopherols, in greater amounts in the external layers; thus, the bran and husk fractions demonstrated a higher antioxidant activity (Butsat & Siriamornpun, 2010). Therefore preparation of the mouthwash  out of this product could be of a great benefit.

Aim: The purpose of the study is to evaluate and compare the effectiveness of Rice husk extract mouthwash and Kidodent mouthwash for reduction in Salivary Streptococcus Mutans count.

Materials and Methodology: 45 children who meet the inclusion criteria will be assigned into 3 groups randomly by lottery method and concealed allocation is to be done with both participant and the examiner blind. In Group A, children will reveive rice husk mouth wash whereas in Group B placebo is given and in Group C comparator Kidodent mouthwash will be given. The unstimulated saliva should be collected at baseline, 7th , 10th and 15th day and subjected to microbiological analysis to check for the reduction of Streptococcus mutans.

The collected data will be statistically analysed using one-way Anova and repeated measures Anova.


 
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