| CTRI Number |
CTRI/2024/07/071303 [Registered on: 25/07/2024] Trial Registered Prospectively |
| Last Modified On: |
23/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Gurunanda Natural Oil Pulling Oral Rinse in improving oral hygiene |
|
Scientific Title of Study
|
A randomized, multi-centric, single blinded three arm parallel group comparative clinical trial with CPC
0.07 percentage Anti-gingivitis/Antiplaque Oral Rinse and placebo to assess the efficacy and safety of GuruNanda Natural Oil Pulling Oral Rinse in maintaining and improving oral hygiene and periodontal health |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| GNOILRINSE/11/24 Version: 1.0 dated 30.04.2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lekha A MDS |
| Designation |
Senior Lecturer |
| Affiliation |
Sri Ramachandra Dental college |
| Address |
Dept. of Periodontology, Sri Ramachandra Dental college
No.1, Ramachandra Nagar, Sri Ramachandra Nagar, Chennai, Tamil Nadu
Chennai
TAMIL NADU
600116
India |
| Phone |
9884076445 |
| Fax |
|
| Email |
drlekha@sriramachandra.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sakthi Balan MBBS MD |
| Designation |
Consultant Diabetologist and CI |
| Affiliation |
Ki3 Private Limited |
| Address |
Thirumalai Medical Centre,Room No 1, Thirumalai medical centre, No 408 Cuddalaore Road, Nainarmandapam Puducherry
PONDICHERRY
605004
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, Regus Office Centre Services (Chennai) Pvt Ltd. Olympia Technology Park, Level - 2, Altius Block, No -1, SIDCO Industrial Estate, Chennai
Chennai
TAMIL NADU
600032
India |
| Phone |
09003109416 |
| 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 = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sathyanarayanan BDS MDS |
Aarupadai Veedu Medical College & Hospital Puducherry |
HOD Room , Department of Dental Pondy Cuddalore Main road, Kirumam pakkam Bahour Commune Panchayat Puducherry - 607402.
Pondicherry
PONDICHERRY |
0413-2611245
Sathyanarayanan.ramanujam@avmc.edu.in |
| Dr B Ramkumar |
Ram’s Dental Hospital |
Room No 1, No 246, First Floor, Cuddalore Main Road, Mudaliarpet, Puducherry- 605004
Pondicherry
PONDICHERRY |
9003532262
ramunreached@gmail.com |
| Dr Jayalakshmi Somasundaram MDS PhD |
Saveetha Dental College |
Room No 1, White Lab - Material Research Centre
162, Poonamallee High
Road, Chennai, Pincode 600077, Tamilnadu,
Chennai
TAMIL NADU |
9600586858
whitelab.sdc@saveetha.com |
| Dr Lekha A |
Sri Ramachandra Dental college & hospital |
Dept. of Periodontology,
No.1, Ramachandra Nagar, Sri Ramachandra
Nagar, Chennai, Tamil Nadu 600116
Chennai
TAMIL NADU |
9884076445
drlekha@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| ETHIQUE DE LA NATURE ASSOCIATION |
Approved |
| Institutional Human Ethics Committee |
Approved |
| Institutional Human Ethics Committee |
Approved |
| Institutional Human Ethics Committee SRIHER |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K036||Deposits [accretions] on teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CPC 0.07% Anti-gingivitis/Antiplaque Oral Rinse |
Active Ingredient: Cetylpyridinium Chloride 0.07%
Inactive Ingredients: Water, Glycerin, Flavor, Poloxamer 407, sodium saccharin, Methylparaben, Sucralose, propylparaben, blue.
To be used as oral rinse for 2 minutes twice daily in the morning and night for 8 weeks.
|
| Intervention |
GuruNanda Natural Oil Pulling Oral Rinse
(Coconut+ Mint) |
Caprylic/Capric/Lauric Triglycerides, Peppermint Oil,
Spearmint Oil, Clove Oil, Tea Tree Oil, Cardamom oil, Oregano oil, Fennel Oil, Vitamin E, Vitamin D3, Stevia, Vitamin K2.
Shake well. Place 10 ml of GuruNanda Natural Oil
Pulling 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 8 weeks
|
| Comparator Agent |
Placebo Oral Rinse
(Purified water, Glycerin, PEG-40 Hydrogenate Castor Oil, Sodium Benzoate,
Xylitol, Flavor, Sucralose, Citric Acid) |
Place 10 ml of Placebo 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 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 . Systemically healthy adult subjects in the age group of 18-60 years who require oral hygiene support for maintaining or improving periodontal health and who agree to comply with the study procedures.
2. Subjects having gingival probing depth of less than 3mm.
3.Subjects having gingival index scores of equal to 2 and in more than 10 percent of the sites
4.Subjects with no history of hypersensitivity reactions.
5.Able to communicate adequately with the investigator
and to comply with the requirements for the entire
study.
6. Subjects should not have history of periodontal therapy one
7.Subjects having plaque index scores of equal to 2 and in more than 10percent of the sites |
|
| ExclusionCriteria |
| Details |
1.Subjects with mal-aligned teeth, wearing orthodontic appliances and removable partial dentures;
2. Subjects with chronic or aggressive periodontitis;
3. Subjects with history of oral antibiotic prophylaxis within the past
1 month;
4.Tobacco consumers and smokers,
5.Subjects who are on any antibiotic therapy for the past 1 month and subjects with any other medical history that could compromise the conduct of the study
6.Subjects who are pregnant or lactating.
7.Subjects with previous history of any allergic reactions to the test products
8. Subjects participating in concomitant interventional clinical study during the previous 30 days. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Plaque Index (PI) and Modified Gingival Index (MGI) from
baseline to end of study
2. To assess percentage mean reduction CFUs in cariogenic oral microflora (S.mutans) from baseline to end of study.
3. To assess percentage mean reduction CFUs in below species of gram positive from baseline to end of study. (Streptococcus mutans, Streptococcus sobrinus, Streptococcus anginosus, Lactobacillus spp)
4.To assess percentage mean reduction CFUs in fungus from baseline to end of study.
5.Effect of test product in reducing the Cavities
6.Effect of test product in reducing Halitosis
7.Effect of test product in reducing bleeding gums
8.To assess percentage mean reduction CFUs in below gram negative from baseline to end of study. (Porphyromonas gingivalis, Fusobacterium nucleatum,Prevotella intermedia)
|
Baseline , Week 4 and Week 8
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess improvement in Clinical Oral Dryness Score (CODS)
from baseline to end of study.
2. To assess improvement in Organoleptic Scoring Scale (OSS) from
baseline to end of study.
3.To assess improvement in VITA Shade Scale from baseline to end
of study.
4.To assess the safety of test product throughout the study period by
monitoring for any adverse events during the study period of 8
weeks. |
Baseline, week 4 and week 8 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
07/08/2024 |
| Date of Study Completion (India) |
27/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
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
|
60 adults requiring oral hygiene support for maintaining or to improve periodontal health will be enrolled in the study. All the study subjects will receive a set of toothbrush and toothpastes from same manufacturer to overcome the confounding bias. The study subjects will be asked to self-administer the test product 10 ml into their mouth for 2 minutes and will be asked to spit out the content and rinse with normal water once daily in the morning for test & placebo , 10 ml daily in the morning followed by brushing for 8 weeks
Group 1- Gurunanda Natural Oil Pulling oral RInse Group 2- CPC 0.07% anti gingivitis/ Antiplaque oral rinse Group 3- Placebo
Primary Outcome 1) To assess the effect of test Product on OHI, PI and MGI from baseline and end of the study 2) To assess % mean reduction in cariogenic oral microflora from baseline to end of the study 3) To assess % mean reduction CFU in gram positive bacteria 4) TO assess % mean reduction CFU in gram negative bacteria 5) To assess % mean reduction CFU in fungus 6) Effect of test in reducing Cavities 7) Effect of test Product in reducing Halitosis 8) Effect of test product in reducing bleeding gums |