| 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
|
|
|
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
|
|
|
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. |