| CTRI Number |
CTRI/2025/02/080408 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
23/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Safety and Efficacy study of Gurunanda Coco- Mint Oil Pulling Oral Rinse in Teeth Whitening |
|
Scientific Title of Study
|
A Randomized, Multi-Centric, Comparative, Double Blinded Placebo controlled Clinical Study to evaluate the efficacy and safety Of Gurunanda Coco- Mint Oil Pulling Oral Rinse in Improving Tooth Shade (Whitening Efficacy) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| GNWHITERINSE/33/24 Ver 1.0 Dated 21.11.2024 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr K T Magesh MDS |
| Designation |
Vice Principal, Professor & HOD |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Dept of Oral Pathology,
SRM Kattankulathur Dental College
SRMIST, Kattankulathur, Chennai
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
98403 63642 |
| Fax |
|
| Email |
magesht@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Sakthi Balan MD |
| Designation |
Consultant Diabetologist and CI |
| Affiliation |
KI3 PRIVATE LIMITED |
| Address |
No. 5/3,Jayalakshmi Street, Radha Nagar, Chromepet, Chennai- 600 044 Tamil Nadu, India.
Chengalpattu
Chennai
TAMIL NADU
600044
India |
| Phone |
9443627722 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayathri Sivakumar |
| Designation |
Director |
| Affiliation |
KI3 PRIVATE LIMITED |
| Address |
No. 5/3,Jayalakshmi Street, Radha Nagar, Chromepet, Chennai- 600 044 Tamil Nadu, India.
Chennai
TAMIL NADU
600044
India |
| Phone |
9003109416 |
| Fax |
|
| Email |
drgayathri@ki3services.com |
|
|
Source of Monetary or Material Support
|
| GuruNanda LLC
6645 Caballero Blvd, Buena Park, CA 90620
|
|
|
Primary Sponsor
|
| Name |
GuruNanda LLC |
| Address |
6645 Caballero Blvd, Buena Park, CA 90620 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 |
| DrKTMahesh |
SRM Medical College Hospital and Research Centre |
Dept of Oral Pathology, SRM Medical College Hospital and Research Centre
Chennai
TAMIL NADU
Chennai
TAMIL NADU |
9840363642
drktmagesh1973@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K039||Disease of hard tissues of teeth,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gurunanda Coco- Mint Oil Pulling Oral Rinse |
Caprylic/Capric/Lauric Triglycerides, Peppermint Oil,
Spearmint Oil, Clove Oil, Cardamom oil, Tea Tree Oil, Stevia Leaf
Extract, Oregano oil, Fennel Oil, Vitamin E, Vitamin D3, Vitamin K2
Route of administration: Oral Rinse once daily |
| Comparator Agent |
Placebo Rinse |
Purified Water, Glycerin, Propanediol, Xylitol, PEG
Hydrogenated Castor Oil, Sodium Benzoate, Flavor, Citric Acid, Sucralose
Route of administration: Oral Rinse once daily |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.who prefer to improve teeth shade cosmetically and who would want to maintain oral hygiene and to comply with the study procedures.
2.Tooth shade A2 or darker.
3.Good general health with no systemic conditions affecting oral health.
4.Presence of natural teeth with visible extrinsic stains or discoloration.
5.Willingness to avoid other whitening treatments during the study period.
6.Ability to provide informed consent.
7.Compliance with study protocols, including scheduled visits and post-treatment care.
8.Not wearing a clear aligner, retainer, and night guard |
|
| ExclusionCriteria |
| Details |
1.Subjects with mal-aligned teeth, wearing orthodontic appliances and removable partial dentures.
2.Subjects with chronic or aggressive periodontitis who underwent recent whitening intervention.
3.Tobacco consumers and smokers, betel chewers.
4.Subjects who are pregnant or lactating.
5.Subjects with hypersensitivity to any of the test products.
6.Subjects with pre-existing tooth sensitivity.
7.Concurrent use of any other treatment for teeth whitening or sensitivity.
8.Concurrent participation in any other clinical trial or study involving teeth whitening or sensitivity assessment.
9.Severe enamel defects or intrinsic discoloration unrelated to staining.
10.Prior participation in a similar study within the past six months.
11.Current use of medications causing tooth discoloration, such as
tetracycline. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess improvement in VITA shade scale over various assessments.
2.Air Blast Hypersensitivity.
3.Examiner rates the response to stimulation of hypersensitive teeth using a jet of air(Constant stimulus on the basis of duration, pressure, temperature and distance from target).Response is rated on the Schiff cold Air sensitivity Scale.
4.To observe the Enamel by Visual Inspection
5.To observe the Enamel by Tactile Examination using dental probes, the dentist can feel the texture of the enamel by Mohs hardness scale.
6.Picture of pre and post assessment will be taken. |
Visit 1(Day1), Visit 2(week2), Visit 3(week4), Visit4(week6) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the safety of the investigational product throughout the study period for any abnormal findings on gingival and mucosal tissues, dental hard tissues, including but not limited to the gingiva
(free and attached), hard and soft palate, oropharynx/uvula, buccal mucosa, tongue, floor of the mouth, labial mucosa, mucobuccal/mucolabial folds, lips, and perioral area. |
Visit 1(Day1), Visit 2(week2), Visit 3(week4), Visit4(week6) |
Additionally, the oral hard tissues will be assessed and abnormal finding questionnaire: burning mouth, altered taste, sore mouth,
ulcers, change in gum colours, sensitivity etc. |
Visit 1(Day1), Visit 2(week2), Visit 3(week4), Visit4(week6) |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
25/02/2025 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
80 Participants who will fulfill the inclusion and exclusion criteria will consider for the study
Objective: 1.To study the efficacy of Of Gurunanda Coco- Mint Oil Pulling Oral Rinse in Improving Tooth Shade 2.To assess the safety of Gurunanda Coco- Mint Oil Pulling Oral Rinse in Improving Tooth Shade
Study Design: Two-arm, parallel-group, randomized, Multi-Centric double blinded, Placebo Controlled trial
Primary Outcomes: 1.To assess improvement in VITA shade scale over various assessments. 2.Air Blast Hypersensitivity. 3.Examiner rates the response to stimulation of hypersensitive teeth using a jet of air. Response is rated on the Schiff cold Air sensitivity Scale. 4.To observe the Enamel by Visual Inspection 5.To observe the Enamel by Tactile Examination using dental probes, the dentist can feel the texture of the enamel by Mohs hardness scale. 6.Picture of pre and post assessment will be taken.
Secondary outcomes: 1.To assess the safety of the investigational product throughout the study period for any abnormal findings. 2.Additionally, the oral hard tissues will be assessed and abnormal finding questionnaire
Inclusion:(80 participants- 40 Each groups) 1.Systemically healthy adult subjects in the age group of 18-60 years 2.Tooth shade A2 or darker. 3.Good general health with no systemic conditions affecting oral health. 4.Presence of natural teeth with visible extrinsic stains or discoloration. 5.Willingness to avoid other whitening treatments during the study period. 6.Not wearing a clear aligner, retainer, and night guard.
Exclusion: 1.Subjects with mal-aligned teeth, wearing orthodontic appliances and removable partial dentures 2.Current use of medications causing tooth discoloration, such as tetracycline 3.Subjects with chronic or aggressive periodontitis 4.Tobacco consumers and smokers, betel chewers. 5.Subjects who are pregnant or lactating. 6.Subjects with hypersensitivity to any of the test products. 7.Subjects with pre-existing tooth sensitivity 8.Concurrent use of any other treatment for teeth whitening or sensitivity 9.Concurrent participation in any other clinical trial or study involving teeth whitening or sensitivity assessment. 10.Severe enamel defects or intrinsic discoloration unrelated to staining. 11.Prior participation in a similar study within the past six months. |