| CTRI Number |
CTRI/2022/10/046446 [Registered on: 13/10/2022] Trial Registered Prospectively |
| Last Modified On: |
19/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
plaque control using mouthrinses containing fluroide, probiotic and edible coconut oil |
|
Scientific Title of Study
|
Comparative Evaluation of S. mutans count in plaque using Fluoridated Mouthwash, Probiotic Rinse, and Virgin Coconut Oil Pulling in 10-14 years of children - A Randomised Controlled Clinical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Megha Tharani |
| Designation |
PG student |
| Affiliation |
KM Shah Dental college |
| Address |
Department of pediatric and preventive dentistry, KM Shah dental college and hospital, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9403150341 |
| Fax |
|
| Email |
meghatharani12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bhavna Dave |
| Designation |
Professor |
| Affiliation |
KM Shah Dental college |
| Address |
Department of pediatric and preventive dentistry, KM Shah dental college and hospital, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9998034036 |
| Fax |
|
| Email |
bhavnadave1964@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Megha Tharani |
| Designation |
PG student |
| Affiliation |
KM Shah Dental college |
| Address |
Department of pediatric and preventive dentistry, KM Shah dental college and hospital, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9403150341 |
| Fax |
|
| Email |
meghatharani12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of pediatric and preventive dentistry, KM Shah Dental college |
|
|
Primary Sponsor
|
| Name |
Dr Megha Tharani |
| Address |
Department of pediatric and preventive dentistry, KM Shah Dental college, Sumandeep Vidyapeeth University, Piparia, Waghodia, Vadodara |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Megha Tharani |
Department number 3, pediatric and preventive dentistry, KM Shah dental college and hospital |
Sumandeep Vidyapeeth University Piparia Waghodia Vadodara
Vadodara
GUJARAT |
9403150341
meghatharani12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
screening |
| Patients |
(1) ICD-10 Condition: K05||Gingivitis and periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
edible virgin coconut oil |
5 ml of Patanjali virgin coconut oil is to be used for oil pulling. use a spoon of the required quantity and swish in the mouth for 30 seconds twice a day. |
| Comparator Agent |
fluoridated mouthwash |
Colgate Maxfresh plax peppermint flavour is used(5ml) as fluoridated rinse which contains sodium fluoride solution. It is also used for 3o seconds twice a day. |
| Intervention |
Probiotic mouthwash |
This probiotic mouth wash is a lemon mint flavoured mouthwash containing 1.5 billion CFU of bacillus coagulans strain. It is used in 5 ml and rinse off after 30 seconds twice a day. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1. Children between the age group 10-14 years will be included.
2. Children with no recent antibiotic therapy past four weeks.
3. Children with plaque score>0.9 according to Plaque Index given by Loe and silness.
|
|
| ExclusionCriteria |
| Details |
1. Children with clinical evidence of ulcers, abcess or sinus tract or undergoing dental treatment including orthodontic treatment.
2. Children with any predisposing medical/systemic condition
3. Children with any history of sensitivity/allergic reaction to the contents of fluoridated, probiotic mouthwash and virgin coconut oil
|
|
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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, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To evaluate the reduction of S. mutans count after using of fluoridated mouthwash, probiotic rinse and virgin coconut oil pulling |
baseline, 14 days and 28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To check the s mutans microbial count using probiotic mouthrinses |
baseline, 14 days and 28 days |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
24/11/2022 |
| 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="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim of the study : To compare and evaluate the effectiveness of fluoridated mouthwashes, probiotic rinse and virgin coconut oil pulling on S. mutans count in plaque on age group 10-14 years. Objectives of the study : 1. To evaluate the effectiveness of fluoridated mouthwash, probiotic rinse and virgin coconut oil pulling using microbiological analysis of S. mutans at baseline, 14 days and 28 days. 2. To evaluate the effectiveness of fluoridated mouthwash, probiotic rinse and virgin coconut oil pulling using the Plaque Index (Loe and silness) at baseline, 14 days and 28 days. 3. To compare and evaluate the effectivenss of all the three groups using microbiological analysis of S. mutans at baseline, 14 days and 28 days. 4. To compare and evaluate the effectivenss of all the three groups using Plaque Index (Loe and silness) of S. mutans at baseline, 14 days and 28 days. NULL HYPOTHESIS There is no difference between the effectiveness of fluoridated mouthwash, probiotic rinse and virgin coconut oil pulling on the S. mutans count in pediatric population of 10-14 years.
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