| CTRI Number |
CTRI/2024/09/074049 [Registered on: 19/09/2024] Trial Registered Prospectively |
| Last Modified On: |
13/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Preventive
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
How effectively is the ayurvedic oral rinse reducing the oral bacterial level in children?
|
|
Scientific Title of Study
|
Efficacy of Ayurvedic oil oral rinse on the Streptococcus mutans count, Salivary pH and Buffering capacity in children- A prospective clinical study
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr NANTHINI P |
| Designation |
First Year MDS Post graduate student |
| Affiliation |
A B Shetty Memorial Institute of Dental Sciences |
| Address |
Room No: 15, Department of Pediatric and Preventive Dentistry, A B Shetty Memorial Institute of Dental Sciences, Medical Sciences Complex, Deralakatte, Mangaluru
Room No: 15, Department of Pediatric and Preventive Dentistry, A B Shetty Memorial Institute of Dental Sciences, Medical Sciences Complex, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8754448655 |
| Fax |
|
| Email |
nanthini151099@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajmohan Shetty |
| Designation |
Professor |
| Affiliation |
A B Shetty Memorial Institute of Dental Sciences |
| Address |
Room No: 15, Department of Pediatric and Preventive Dentistry, A B Shetty Memorial Institute of Dental Sciences, Medical Sciences Complex, Deralakatte, Mangaluru
Room No: 15, Department of Pediatric and Preventive Dentistry, A B Shetty Memorial Institute of Dental Sciences, Medical Sciences Complex, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9448253296 |
| Fax |
|
| Email |
rajmohanshetty4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr NANTHINI P |
| Designation |
First Year MDS Post graduate student |
| Affiliation |
A B Shetty Memorial Institute of Dental Sciences |
| Address |
Room No: 15, Department of Pediatric and Preventive Dentistry, A B Shetty Memorial Institute of Dental Sciences, Medical Sciences Complex, Deralakatte, Mangaluru
Room No: 15, Department of Pediatric and Preventive Dentistry, A B Shetty Memorial Institute of Dental Sciences, Medical Sciences Complex, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8754448655 |
| Fax |
|
| Email |
nanthini151099@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self funded : The study is being conducted at AB Shetty Memorial Institute of Dental Sciences, Medical Sciences Complex, Deralakatte, Mangaluru- 575018, Dakshina Kannada, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Dr Nanthini P |
| Address |
Room No:15, 4th Floor, Department of Pediatric and Preventive Dentistry, AB Shetty Memorial Institute of Dental Sciences, Deralakatte, Mangaluru-575018 Karnataka, India |
| Type of Sponsor |
Other [Self Funded] |
|
|
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 Nanthini P |
AB SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES |
Room No:15, 4th floor, Department of Pediatric and Preventive Dentistry, AB Shetty Memorial Institute of Dental Sciences , Deralakatte, Mangalore
Dakshina Kannada
KARNATAKA |
8754448655
nanthini151099@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe, AB Shetty Memorial Institute of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
School Children |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | kavalaH gaNDUShaH | (Procedure Reference: Oil oral rinse, Procedure details: (Procedure Reference: Oil oral rinse, Procedure details: (Procedure Reference: Ayurvedic literature, Procedure details: The healthy participants will be asked to routinely perform oral rinse with Ayurvedic oil -Munident, every day in the morning after brushing in empty stomach for 2–3 minutes. Oil oral rinsing will be done under the observation of a parent or care giver. The children will be provided 200 mL (5–10 ml daily - one table spoon) of Ayurvedic oil and will be asked to rinse it all over the oral cavity with the mouth closed and to forcefully move it in between the teeth. It will be given in addition to routine once-a day after brushing for 30 days))
|
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
1) Children of either gender aged 10-13 years.
2) Children with DMFTS / defs score between 0-2 [19]
3) Children whose parents are well motivated and willing to give informed consent.
|
|
| ExclusionCriteria |
| Details |
1) Children who have DMF score more than 2
2) Children using any mouthwash
3) Children who have undergone antibiotic therapy and/or fluoride treatment within the past 3 to 4 weeks
4) Children undergoing orthodontic treatment
â–ª Medically compromised children
â–ª Uncooperative children
â–ª Children whose parents are not willing to give their consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The aim of this study is to quantify and compare the efficacy of ayurvedic oil on
Streptococcus mutans count, pH and buffering capacity of the salivary samples collected from
children before and after oral rinse. |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To quantify the levels of Streptococcus mutans at baseline and after the usage of
ayurvedic oil oral rinse in children.
• To evaluate the pH and buffering capacity of saliva at baseline and after the usage of
ayurvedic oil oral rinse in children.
• To compare and correlate the above parameters before and after oil oral rinse.
|
1 month |
|
|
Target Sample Size
|
Total Sample Size="63"
Sample Size from India="63"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
18/10/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Oil oral rinse is an ancient Ayurvedic remedy for oral health and detoxification. It can be performed using edible oils such as sesame oil is a powerful detoxifying Ayurvedic technique that has recently become very popular in reducing dental caries. Thus, we use ayurvedic oil oral rinse and quantify the streptococcus mutans count and assess caries activity to reduce and arrest the caries as an early intervention and home care measure. The participants will be asked to routinely perform oral rinse with Ayurvedic oil -Munident, every day in the morning after brushing in empty stomach for 2– 3 minutes. Oil oral rinsing will be done under the observation of a parent or care giver. The children will be provided 200 mL (5–10 ml daily - one table spoon) of Ayurvedic oil and will be asked to rinse it all over the oral cavity with the mouth closed and to forcefully move it in between the teeth. It will be given in addition to routine once-a-day brushing method for 30 days. The study shall be conducted as follows: During the first dental visit: Following will be performed: • Measurement of DMF, Gingival and plaque index as per modified Silness and Loe criteria with index teeth chosen in every case. • Collection of Saliva for quantification of Streptococcus mutans, assessing pH and buffering capacity. Prescription of ayurvedic oil . Second dental visit : After 15 days of oil oral rinse, • Measurement of Gingival and plaque index as per modified Silness and Loe criteria with index teeth chosen in every case in both groups after 15 days. Collection of Saliva for quantification of Streptococcus mutans, assessing pH and buffering capacity in both the groups. During the third dental visit: After 30 days of oil oral rinse, • Measurement of Gingival and plaque index as per modified Silness and Loe criteria with index teeth chosen in every case after 30 days. • Collection of Saliva for quantification of Streptococcus mutans, assessing pH and buffering capacity. |