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
|
|
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.
|