| CTRI Number |
CTRI/2025/02/079996 [Registered on: 06/02/2025] 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
|
To find the effect of Gurunanda Oil Pulling Oral Rinse with Ashwagandha & Neem in reducing teeth Sensitivity |
|
Scientific Title of Study
|
A Randomized, Multi-centric, Double blinded three arm, Placebo and Active Controlled parallel group comparative clinical trial to assess the efficacy and safety of Gurunanda Oil Pulling Oral Rinse with Ashwagandha & Neem in reducing the sensitivity of teeth and gums. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| GNASHWAGANDAOIL/32/24 Ver 1.0 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Aravindhan R Ph.D |
| Designation |
Associate professor |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Room No 1,
Department of Oral & Maxillofacial Pathology
SRM Kattankulathur dental college SRMIST, KattanKulathur, Chennai
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9790801260 |
| Fax |
|
| Email |
aravindhandr@gmail.com |
|
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.
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 = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr R C Satish Kumar |
SRM Medical College Hospital and Research Centre |
Dept. of Oral Pathology, SRM Medical College Hospital and Research Centre
Chennai
Kancheepuram
TAMIL NADU |
9884845887
ayurbheshaja@gmail.com |
| Dr Madhushriee Venkatesan |
Vinayaka Missions Sankarachariyar Dental College |
Room No 1, Sankari Main Road (NH-47) Ariyanoor, Salem - 636308 Tamil Nadu, India
Salem
Kancheepuram
TAMIL NADU |
9740575508
drmadhushriee@vmsdc.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gurunanda Oil Pulling Oral Rinse with Ashwagandha & Neem |
Caprylic/Capric/Lauric Triglyceride, Cinnamon Oil, Ashwagandha Extract, Clove Oil, Cardamom Oil, Tea Tree Oil, Turmeric Extract, Roman Chamomile Oil, Vitamin E, Vitamin D3, Oregano Oil, Stevia Leaf Extract, Vitamin K2, Neem Extract
Usage: 10 mL once a day. Rinse for at least 2 minutes. |
| Comparator Agent |
Listerine Sensitivity Mouthwash |
Water, Sorbitol, Propylene Glycol, Dipotassium Oxalate Monohydrate, Flavor, Phosphoric Acid, Poloxamer, Sodium Benzoate, Sodium Methyl Cocoyl Taurate, Sodium Lauryl Sulfate, Sucralose, Sodium Saccharin
Directions
Use twice-daily after brushing After brushing, rinse mouth with water before use Pour 2 teaspoonfuls (10 mL) into a cup, rinse for 60 seconds, then spit out Do not exceed the recommended twice per day dose of 2 teaspoonfuls (10 mL) Do not dilute, swallow |
| Comparator Agent |
Placebo Rinse (Purified Water, Glycerin, Propanediol, Xylitol, PEG Hydrogenated Castor Oil, Sodium Benzoate, Flavor, Citric Acid, Sucralose) |
Shake well. Place 10 ml of Oral Rinse in mouth. Gently swish between teeth for at least 2 minutes. Spit out and rinse mouth thoroughly with water. DO NOT SWALLOW.Always brush your teeth after using oil pulling. To be used twice daily for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants aged 18 to 50 years.
2. Presence of a minimum of 20 teeth.
3.Presence of tooth sensitivity (index of the intensity of teeth hyperesthesia, IIGZ score greater than 2).
4.Adequate oral hygiene and no signs of oral neglect.
5. Qualifying response to the Air Blast stimuli as defined by a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale.
6. Use of a non-desensitizing dentifrice for one month prior to entry into the study.
Participant is willing to provide informed consent and is willing to participate in all procedures and follow up evaluations necessary to complete the study
7. |
|
| ExclusionCriteria |
| Details |
1. Professional teeth cleaning and whitening less than 30 days before the examination.
2. Carrying out other dental procedures, including orthodontic and surgical, less than 30 days prior to the study, or the need to carry out them during the study period.
3. The use of analgesic agents less than 7 days prior to inclusion.
4. Untreated dental caries or active periodontal disease
5. Presence of cracked, chipped, or fractured teeth.
6. Severe enamel loss, dentin exposure, or pulpitis
7. Teeth whitening, scaling, or polishing within the past 4–6 weeks.
8. Recent restorations or oral surgeries that could influence sensitivity.
9. Regular use of desensitizing toothpaste or treatments within the past 4 weeks
10. Use of prescription fluoride treatments or other dental products specifically targeting sensitivity
11. Conditions affecting oral health, such as diabetes, Sjögren’s syndrome, or GERD
12. Excessive consumption of acidic foods or beverages
13. Heavy tobacco or alcohol use that could affect oral health or study results.
14. History of bruxism, clenching, or other habits that could increase tooth wear.
15. Known allergies to any components of the products being tested.
16. Conditions or medications that might interfere with the perception of sensitivity (e.g., pain medications)
17. Participation in any other clinical study or test panel within one month prior to entry into the study.
18. History of Hepatitis B or C, HIV infection.
19. Chemotherapy, radiation therapy or cytokine therapy less than 5 years before being included in the study
20. Pregnant or lactating participants. |
|
|
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.Objective assessment of the sensitivity of hard tooth tissue, an index of the intensity of teeth hyperesthesia (IIGZ) will be used
2.A visual analogue scale is proposed for self-assessment by the participant of the level of pain in the samples, where the values from 1 to 3 corresponded to the light intensity of pain, from 4 to 6 points - moderate, and 7 or higher – strong
3.To evaluate the cleaning effect of studied products Oral Hygiene Index Simplified (OHI-S) [ Time Frame: Baseline to 4 weeks]
4. Air Blast Hypersensitivity [ during each visit over 1-4 weeks]
5. Examiner rates the response to stimulation of hypersensitive teeth using a jet of air (constant stimulus based on duration, pressure, temperature, distance from target). Response is rated based on the Schiff Cold Air Sensitivity Scale.
6. Reductions in extrinsic tooth stain area and extrinsic tooth stain intensity.
7. Photographic Assessment |
Baseline,Week 1, Week 2 , Week 3 and Week 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Participant and Investigator Feedback will be obtained before enrollment and after completion of the study
Adverse event monitoring |
Baseline,Week 1, Week 2 , Week 3 and Week 4 |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
06/02/2025 |
| 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="10"
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
|
The participants will be sequentially and randomly assigned the groups according to the computer -generated code.
Group 1- 30 subjects- GuruNanda Oil Pulling Oral Rinse with Ashwagandha and Neem, once daily for 4 weeks
Group 2- 30 subjects- Listerine Sensitivity Mouhtwash
Group 3- 30 subjects- Placebo Oral Rinse
Primary Outcome
1) Objective Assessment of the sensitivity of hard tooth tissue, an index of the intensity of teeth hyperesthesia (IIGZ) 2) A Visual Analogue scale is proposed for self-assessment by the participant of the level of pain in the samples 3) To evaluate the cleaning effect of studied products Oral Hygiene Index Simplified (OHI-S) 4) Air Blast Hypersensitivity (Baseline to 4 weeks) 5) Reductions in extrinsic tooth stain area and extrinsic tooth stain intensity 6) Photographic Assessment of dental Hygiene
Secondary Outcome 1) Participant and Investigator Feedback 2) Adverse event monitoring |