| CTRI Number |
CTRI/2025/02/081110 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| 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 GURUNANDA oil pulling oral rinse in reducing sensitivity in Patients with Sensitive tooth |
|
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 in reducing the sensitivity of
teeth and gums. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| GNOILRINSE/31/24 Ver 1.0 Dated 27.11.2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R C Satish Kumar |
| Designation |
Principal Investigator |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Dept. of Conservative
Dentistry, SRM Medical College Hospital and Research Centre
Pondicherry
PONDICHERRY
603203
India |
| Phone |
09843591097 |
| Fax |
|
| Email |
ayurbheshaja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Sakthi Balan MD |
| Designation |
Consultant Diabetologist and CI |
| Affiliation |
KI3 PRIVATE LIMITED |
| Address |
Room No 1, No 5/3 Jayalakshmi Street,Radha Nagar, Chromepe
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 |
Room No 1, No 5/3 Jayalakshmi Street,Radha Nagar, Chromepet
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 Sihivahanan |
SRM Medical College Hospital and Research Centre |
Dept. of Conservative Dentistry, SRM Medical College Hospital and Research Centre
Chennai
TAMIL NADU |
99403 16750
shivahad@srmist.edu.in |
| Dr Mohamed Adhil K |
Vinayaka Missions Sankarachariyar Dental College |
Sankari Main Road (NH-47)
Ariyanoor, Salem - 636308 Tamil Nadu,
India
Salem
TAMIL NADU |
7010374054
drmohamedadhil@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: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gurunanda 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
Frequency: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
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
Direction of Usage: 10 mL once a day. Rinse for at least 2 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Presence of a minimum of 20 teeth
2.Presence of tooth sensitivity
3.Adequate oral hygiene and no sign of oral neglect
4.Qualifying response to the Air Blast Stimuli by Schiff Cold Air Sensitivity Scale
5.Use of a non-desensitizing dentifrice for one month prior to entry into the study
|
|
| 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.
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, 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.
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).
2.A visual analogue scale is proposed for self-assessment by the participant of the level of pain.
3.To evaluate the cleaning effect of studied products Oral Hygiene Index Simplified (OHI-S).
4.Air Blast Hypersensitivity.
5.Examiner rates the response to stimulation of hypersensitive teeth using a jet of air Response is rated based on the Schiff Cold Air Sensitivity Scale 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 of dental hygiene. |
Visit 1(Day1), Visit 2(week1), visit 3(week2), visit 4(week3), visit 5(week4) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Participant and Investigator Feedback will be obtained before enrollment and after completion of the study.
2.Adverse event monitoring. |
Visit 1(Day1), Visit 2(week1), visit 3(week2), visit 4(week3), visit 5(week4) |
|
|
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)
|
28/02/2025 |
| 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
|
To assess the Efficacy and safety GURUNANDA OIL pulling oral rinse in reducing the sensitivity of teeth and gums.
Objective:1.To study the efficacy of Gurunanda Oil Pulling Oral Rinse in reducing the sensitivity of teeth and gums and compare with Listerine Sensitivity Mouthwash and placebo. 2.To assess the safety of Gurunanda Oil Pulling Oral Rinse by monitoring the occurrence of any adverse effects.
Study Design: Three-arm, parallel-group, randomized, multi-centric, double blinded, active comparator & placebo-controlled
Primary Outcomes: 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. 3.To evaluate the cleaning effect of studied products Oral Hygiene Index Simplified (OHI-S). 4.Air Blast Hypersensitivity. 5.Examiner rates the response to stimulation of hypersensitive teeth using a jet of air Response is rated based on the Schiff Cold Air Sensitivity Scale 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 of dental hygiene.
Secondary Outcomes: 1.Participant and Investigator Feedback will be obtained before enrollment and after completion of the study. 2.Adverse event monitoring.
Inclusion (90 participants - Each Group 45 participants) 1.Presence of a minimum of 20 teeth. 2.Presence of tooth sensitivity. 3.Adequate oral hygiene and no sign of oral neglect. 4.Qualifying response to the Air Blast Stimuli by Schiff Cold Air Sensitivity Scale. 5.Use of a non-desensitizing dentifrice for one month prior to entry into the study.
Exclusion: 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. 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, 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. 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. |