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CTRI Number  CTRI/2025/06/088449 [Registered on: 09/06/2025] Trial Registered Prospectively
Last Modified On: 17/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical study to understand the effectivenss of an oral mouthwash in teeth whitening.  
Scientific Title of Study   A double blind, single centric, placebo controlled randomized study to demonstrate the whitening efficacy and tolerability of Gurunanda oil pulling (coco-mint) oral rinse in adults. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
GN_SCRS_GNWTOR_2025, Version-01  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashwin Prabhu 
Designation  Principal Investigator 
Affiliation  Rajalakshmi Hospital and Research Center 
Address  Rajalakshmi Hospital and Research Center. Department of Dental Science, Ground Floor, Room Number-3, No.21/1, Lakshmipura Main Road, Vidyaranyapura Post

Bangalore
KARNATAKA
560097
India 
Phone  9845011615  
Fax    
Email  ashwinprabhu@dscds.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Deepa Subramanian  
Designation  CEO 
Affiliation  Syncretic Clinical Research Services Pvt. Ltd 
Address  Syncretic Clinical Research Services Pvt. Ltd. Department of Clinical Operations, Manidweep, 3rd Floor, C-2, No.13, Dynasty Layout Mariannapalya, H.A. Farm (post), Hebbal

Bangalore
KARNATAKA
560024
India 
Phone  9972598010  
Fax    
Email  deepa@syncretic.in  
 
Details of Contact Person
Public Query  
Name  Dr Deepa Subramanian  
Designation  CEO 
Affiliation  Syncretic Clinical Research Services Pvt. Ltd 
Address  Syncretic Clinical Research Services Pvt. Ltd. Department of Clinical Operations, Manidweep, 3rd Floor, C-2, No.13, Dynasty Layout Mariannapalya, H.A. Farm (post), Hebbal


KARNATAKA
560024
India 
Phone  9972598010  
Fax    
Email  deepa@syncretic.in  
 
Source of Monetary or Material Support  
GURUNANDA 6645 Caballero Blvd, Buena Park, California, Pin code - 90620 United States of America  
 
Primary Sponsor  
Name  GURUNANDA  
Address  6645 Caballero Blvd, Buena Park, California, Pin code - 90620 United States of America  
Type of Sponsor  Other [[Manufacturer, Limited Company] ] 
 
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 Ashwin Prabhu  Rajalakshmi Hospital and Research Center  Department of Dental Science, Ground Floor, Room Number-3, No.21/1, Lakshmipura Main Road, Vidyaranyapura Post
Bangalore
KARNATAKA 		 9845011615

ashwinprabhu@dscds.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Rajalakshmi Hospital Institutional Ehtics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Gurunanda oil pulling (coco-mint) oral rinse  10 ml oral rinse once a day orally for 4 weeks 
Comparator Agent  Placebo   10 ml oral rinse once a day orally for 4 weeks  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Adult male or female subjects (age 18-65 yrs),
2.Subjects with atleast 20 permanent teeth excluding third molar.
3.Non-smokers with good oral and general health.
4.All 6 anterior maxillary teeth free of caries or restorations.
5.Tooth shade A2 or darker with no cervical lesions or prosthodontics treatments and with no periodontal disease.
6.Subjects should not use mouthwash 1 week prior to screening and during the whole course of the study.
7.All subjects should use the same toothpaste during the entire course of the study.
8.Able to communicate adequately with the investigator and to comply with the requirements for the entire study.
9.Subjects should not have history of periodontal therapy one month prior to screening.
10.Patient should be able to give written informed consent prior to participating in the study. 
 
ExclusionCriteria 
Details  1.Individuals with discolored teeth (eg:- tetracycline and fluorosis).
2.Subjects having intrinsic stains.
3.Steroidal anti-inflammatory drugs, NSAIDs one month prior to screening.
4.Concomitant diseases (i.e. cancer, kidney diseases, liver diseases, neurological diseases, diabetes, gastritis psychiatric diseases, blood disorders, gastrointestinal diseases).
5.Subjects with known sensitivity or oral mucosal tissue reaction to any components of the investigational product.
6.Pregnancy and breastfeeding women.
7.Participation in concomitant interventional clinical study during the previous 30 days.
8.Active oral infections, untreated cavities, or periodontal disease.
9.Presence of restorations on front teeth (e.g., crowns, veneers, or composite fillings) that could affect whitening results.
10.Recent dental procedures (e.g., scaling, polishing, or whitening) within the last 4 weeks.
11.Concurrent use of whitening products or treatments within the past 4 weeks.
12.Heavy tobacco use, including cigarettes, cigars, or smokeless tobacco.
13.Consumption of stain-causing substances (e.g., red wine, coffee, tea) that cannot be avoided during the study period.
14.Use of medications that may affect tooth discoloration (e.g., tetracyclines, chlorhexidine).
15.Presence of orthodontic appliances, except for removable retainers.
16.Signs of advanced enamel wear, dentin exposure, or tooth fractures. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Improvement in teeth whitening  Screening,Day 0, week 2, week 4 
 
Secondary Outcome  
Outcome  TimePoints 
1.Physical Examination
2.Oral examination.
3.Vital Signs: Pulse rate, blood pressure and body temperature
4.Lab assessment (Hematology, Biochemistry- SGOT, SGPT,and Serum Creatinine) (needed for safety evaluation
5. Adverse Event Assessments
6.Overall tolerability and satisfaction 		 Screening, week 2, week 4. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   12/06/2025 
Date of Study Completion (India) 16/07/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

This is a double blind, randomized, placebo controlled study. This study is to evaluate the teeth whitening effectiveness and safety of active when compared to placebo. Study is planned to be conducted in a clinical site where EC is registered with CDSCO. Study will be only initiated after receiving CTRI registration number.

Based on inclusion/exclusion criteria subjects with tooth shade of more than A2 will be randomised into the trial. The study population is 100 subjects, 50 subjects on active and 50 subjects on placebo. The duration of the study is 4 weeks from baseline with 4 visits. 

The study outcome are;

Primary outcome - Improvement of teeth whitening.
Secondary outcome - Safety assessment

Study design - Randomized, double blind, placebo controlled  study.
 
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