| CTRI Number |
CTRI/2026/02/103290 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
08/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison of Oil Pulling, Herbal Mouthwash and Fluoride Mouthwash in Reducing Cavity-Causing Bacteria: A Randomized Clinical Trial |
|
Scientific Title of Study
|
Evaluation And Comparison of the Efficacy of Oil Pulling and Herbal Mouthwash Against Commercially Available Fluoride Mouthwash on Caries Activity of Lactobacillus: An In Vivo 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 Shilpa S Naik |
| Designation |
Professor And Head of Department |
| Affiliation |
DY PATIL DEEMED TO BE UNIVERSITY SCHOOL OF DENTISTRY |
| Address |
Department of Pediatric and Preventive Dentistry
Dr DY Patil Deemed to be University
DY Patil School of Dentistry
Sector 7
Highway Road Nerul
Navi Mumbai
MAHARASHTRA
400706
Thane MAHARASHTRA 400706 India |
| Phone |
9769600440 |
| Fax |
|
| Email |
shilpa.naik@dypatil.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Nidhi Vaibhav Shetiya |
| Designation |
Postgraduate Student |
| Affiliation |
DY PATIL DEEMED TO BE UNIVERSITY SCHOOL OF DENTISTRY |
| Address |
Department of Pediatric and Preventive Dentistry
Dr DY Patil Deemed to be University
DY Patil School of Dentistry
Sector 7
Highway Road Nerul
Navi Mumbai
MAHARASHTRA
400706
Thane MAHARASHTRA 400706 India |
| Phone |
9011048548 |
| Fax |
|
| Email |
dvshetiya295@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Nidhi Vaibhav Shetiya |
| Designation |
Postgraduate Student |
| Affiliation |
DY PATIL DEEMED TO BE UNIVERSITY SCHOOL OF DENTISTRY |
| Address |
Department of Pediatric and Preventive Dentistry
Dr DY Patil Deemed to be University
DY Patil School of Dentistry
Sector 7
Highway Road Nerul
Navi Mumbai
MAHARASHTRA
400706
Thane MAHARASHTRA 400706 India |
| Phone |
9011048548 |
| Fax |
|
| Email |
dvshetiya295@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Pediatric and Preventive Dentistry |
| Address |
Department of Pediatric and Preventive Dentistry
Dr DY Patil Deemed to be University
DY Patil School of Dentistry
Sector 7
Highway Road Nerul
Navi Mumbai
MAHARASHTRA
400706 |
| Type of Sponsor |
Private medical college |
|
|
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 Nidhi Vaibhav Shetiya |
Dr DY Patil Deemed to be University DY Patil School of Dentistry |
Department of Pediatric and Preventive Dentistry
Dr DY Patil Deemed to be University
DY Patil School of Dentistry
Sector 7
Highway Road Nerul
Navi Mumbai
MAHARASHTRA
400706 Thane MAHARASHTRA |
9011048548
dvshetiya295@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL RESEARCH AND ETHICAL BOARD DY PATIL UNIVERSITY SCHOOL OF DENTISTRY NAVI MUMBAI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HIGH CARIES RISK PATIENT (DMFT 6) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Coconut Oil Pulling
Herbal Mouthwash |
Kapiva Cold Pressed Coconut Oil Himalaya ORO T Herbal Mouthwash |
| Intervention |
Distilled Water |
Distilled Water |
| Comparator Agent |
Fluoride Mouthwash |
Fluoritop Mouth Wah Orange |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children between 7 to 12 years of age
Normal healthy children
ASA I and II
Written informed consent signed by parents
|
|
| ExclusionCriteria |
| Details |
ASA III and IV
Systemic disease
Severe periodontal disease
Oral infection or pathology
Known allergy to oil, herbal content, or fluoride use of any antibiotics or probiotics or mouthwash within last four weeks
History of dental treatment in last six months
Consent not given by parents
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of oil pulling and Herbal mouthwash on Caries activity of lactobacillus |
Baseline and 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="48" Sample Size from India="48"
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)
|
01/03/2026 |
| 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="14" |
|
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
|
| Randomized, controlled, four-arm parallel-group clinical trial will be conducted among children aged 7–12 years presenting at the Out-patient Department of Pediatric and Preventive Dentistry, D.Y. Patil University, School of Dentistry, Navi Mumbai. After thoroughly explaining the technique, informed consent from parents willing to participate in the study will be obtained, the children will then be randomized into 4 groups using parallel-group design. - Group 1 – Oil Pulling Group
- Group 2 – Fluoride Mouthwash Group
- Group 3 – Herbal Mouthwash Group
- Group 4 – Control Group (Distilled Water)
To maintain standardization all participants will undergo oral prophylaxis prior to the commencement of the study. Along with that, they will also be provided by all the necessary material required for intervention. Participants in Group 1 will be instructed to swish their oral cavity with one teaspoon (5 mL) of virgin coconut oil for 5 minutes on an empty stomach and spit the oil, followed by rinsing with warm water and brushing their teeth with a standard toothpaste. Participants in Group 2 will be instructed to brush their teeth with standard toothpaste, followed by rinsing with fluoride mouthwash as per the manufacturer’s instructions (10 mL for 1 minute) Participants in Group 3 will be instructed to brush their teeth with standard toothpaste followed by swishing the oral cavity using Herbal mouthwash as per manufacturer’s instructions (10 mL for 1 minute) Participants in Group 4 will be instructed to brush their teeth with standard toothpaste, followed by swishing with 10 ml distilled water. To ensure proper adherence to the procedure, a weekly chart will be provided to the parent or guardian of each participant. Additionally, participants will be asked to send a daily video demonstrating the intervention being performed. Intervention will be conducted over a period of two weeks. Saliva samples will be collected at two time points: baseline and at two weeks post-intervention. Each sample would be plated for microbiological analysis with quantification of CFU of Lactobacilli. Saliva samples will be collected using a sterile cotton swab from the affected tooth and placed directly into a sterile tube. These samples will be stored at 4°C in a refrigerator until they are transported to a regional microbiology laboratory in an insulated ice box. Once at the laboratory, the samples will be diluted and gently mixed to ensure uniformity. A 100 µL of the saliva sample will be streaked onto Blood agar plates using a sterile loop, and the sample will be evenly spread with a sterile spreader. The plates will then be incubated at 37°C for 48 hours under microaerophilic conditions. After incubation, the colonies will be examined for morphological characteristics. Further identification of the colonies will be performed using biochemical tests, such as Gram staining and the catalase test. The lactobacillus colonies will be counted using a colony counter. | |