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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  
NIL 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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