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CTRI Number  CTRI/2024/10/075446 [Registered on: 17/10/2024] Trial Registered Prospectively
Last Modified On: 08/02/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Oral care product]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   GuruNanda Oil Pulling Oral Rinse for Teeth Whitening and Oral Hygiene 
Scientific Title of Study   Assessing the efficacy of GuruNanda advance pulling oil versus Colgate® optic white® mouthwash in teeth whitening and overall oral hygiene improvement: double-blind, active & placebo-controlled, randomized comparative study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/24-25/028 Version: 1.00; Dated, 05-August-2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajlaxmi Patil 
Designation  Consulting Dentist 
Affiliation  Lokmanya Medical Research Centre 
Address  Fourth floor OPD 401 314 B Telco Road Chinchwad Pune.

Pune
MAHARASHTRA
411057
India 
Phone  8669081953  
Fax  -  
Email  drrajlaxmiresearch@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gayatri Ganu 
Designation  Managing Director  
Affiliation  Mprex Healthcare Pvt. Ltd. 
Address  Fifth floor, Office Number 501,514 Crossroads, Bhumkar Square, Wakad

Pune
MAHARASHTRA
411057
India 
Phone  8554912644  
Fax  -  
Email  gayatri.mbgindia@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Gayatri Ganu 
Designation  Managing Director  
Affiliation  Mprex Healthcare Pvt. Ltd. 
Address  Fifth floor, Office Number 501,514 Crossroads, Bhumkar Square, Wakad

Pune
MAHARASHTRA
411057
India 
Phone  8554912644  
Fax  -  
Email  gayatri.mbgindia@gmail.com  
 
Source of Monetary or Material Support  
GuruNanda LLC 6645 Caballero Blvd., Buena Park California-90620 United States  
 
Primary Sponsor  
Name  GuruNanda LLC 
Address  GuruNanda LLC 6645 Caballero Blvd., Buena Park California-90620 United States  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Tushar Ghode  Ayushri Multispeciality Hospital   Samadhan Chowk Pimprigaon Pimpri,Pune- 411017, Maharashtra, India
Pune
MAHARASHTRA 
8767762332
-
drtusharayushrihospital@gmail.com 
Dr Rajlaxmi Patil  Lokmanya Medical Research Centre and Hospital  Fourth floor OPD 401 314 B Telco Road Chinchwad Pune.
Pune
MAHARASHTRA 
8669081953
-
drrajlaxmiresearch@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethics Committee Lokmanya Medical Research Centre  Approved 
Institutional Ethics Committee Lokmanya Medical Research Centre  Approved 
Institutional Ethics Committee Sangvi Multispecialty Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Oral Health and Teeth Whitening 
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  Colgate Optic White Mouthwash   Use 15 mL twice a day. Rinse mouth thoroughly for 30 seconds and expel for 2 weeks.(Do not swallow) 
Intervention  GuruNanda Oil Pulling Oral Rinse   Use 10 mL for 2 minutes, ideally in the morning before brushing for 2 weeks.(Do not swallow) 
Comparator Agent  Placebo Rinse   Use 10 mL for 2 minutes, ideally in the morning before brushing for 2 weeks.(Do not swallow) 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1.Healthy male and female aged 25 to 55 years (Both include)2.Individuals with generally healthy oral tissues, as confirmed by a comprehensive dental examination. This includes no current or recent (within the last 6 months) periodontal treatment or significant oral diseases.3.Participants who have all incisors and canines in the upper and lower jaw.4.Individuals in good general health without any systemic conditions or medications that could affect oral health or interfere with the study treatments.5.Participants who provide written informed consent to participate in the study and comply with all study procedures and requirements. 
 
ExclusionCriteria 
Details  1.Suspected alcohol or substance abuse e.g. amphetamines, benzodiazepines, cocaine, and marijuana opiates.
2.Individuals with current alcohol or tobacco use.
3.Females who are pregnant or breastfeeding.
4.Known sensitivity or history of significant adverse effects to any of the investigational products.
5.Significant unstable or uncontrolled medical condition which may interfere with a subjects participation in the study.
6.Participated in tooth stain removal trials in the least 3 months.
7.Individuals who are unable to adhere to the study protocol or have conditions that may interfere with compliance, including cognitive impairments or language barriers.
8.Participants using antibiotics or other medications that could affect oral health or interfere with the study results.
9.Participants involved in concurrent studies with similar assessments or interventions.
10.Participants experiencing severe dry mouth like xerostomia.
11.Participants with chronic bad breath halitosis.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Changes in VITA Shade Scale.
2. Changes in Macpherson’s Modified Stain Index.
3. Changes in tooth sensitivity and gum discomfort using Wong Bakers Face Scale.  
baseline, week 1 and week 2.
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Changes in Investigational Product on Plaque Index (PI) and Modified Gingival Index (MGI).
2. Changes in % mean reduction CFUs in Gram-positive and negative bacteria.
3. Changes in improvement in Clinical Oral Dryness Score (CODS).
4. Changes in Organoleptic Scoring Scale (OSS).
5. Compliance and tolerability will be assessed.
 
baseline, week 1, and week 2 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "97"
Final Enrollment numbers achieved (India)="97" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   28/10/2024 
Date of Study Completion (India) 24/02/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   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 study is based on the growing acknowledgment of oil pulling with coconut oil as a potentially effective adjunctive therapy in oral hygiene. Ayurvedic traditions have long advocated for oil pulling as a preventive measure for oral diseases and overall health enhancement. Recent research has corroborated these claims, demonstrating that coconut oil can significantly reduce plaque index, gingival index, and levels of pathogenic bacteria, largely attributed to its high lauric acid content. Lauric acid exhibits notable antimicrobial properties, including the disruption of bacterial cell membranes and the inhibition of microbial signal transduction, supporting its efficacy in oral health management.

Despite these promising findings, the integration of oil pulling or the use of oil-based mouthwashes, compared to water-based mouthwashes, into contemporary dental practice remains inadequately explored and lacks comprehensive, standardized evidence. Additionally, the use of essential oils in oral hygiene practices also lacks sufficient scientific validation. This study seeks to address these deficiencies by systematically assessing the impact of  MCT oil infused with select essential oils  on key oral health and hygine indicators,  such as plaque and gingival indices, whitening efficacy, and antimicrobial effectiveness. Additionally, the study will investigate its effects on systemic health by evaluating relevant biomarkers. The results will provide valuable insights into the potential incorporation of oil based mouthwash as a supplementary practice to established oral hygiene protocols, thereby enhancing preventive measures and expanding therapeutic options for both dental and systemic health.

This study aims to bridge the gap between traditional Ayurvedic practices and modern dental care by rigorously evaluating the efficacy of essential oil pulling. By examining its impact on oral health and hygiene indicators as well as relevant biomarkers for systemic health, the findings will contribute to evidence-based integration of oil pulling into contemporary oral hygiene practices, potentially advancing both preventive and therapeutic oral health strategies.

 
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