| CTRI Number |
CTRI/2024/06/068543 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
14/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical study to understand efficacy and safety of new mouthwash in adults |
|
Scientific Title of Study
|
A single blind, single centric, randomized 3 arm parallel study to demonstrate the efficacy and tolerability of Gurunanda Natural Oil Pulling Oral Rinse in the management of Gum Health and Gingivitis when compared to CPC (comparator) based mouthwashand Placebo. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| GN_SCRS_GNOPOR01_2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashwin Prabhu |
| Designation |
Principal Investigator |
| Affiliation |
Rajalakshmi Hospital |
| Address |
Rajalakshmi Hospital
Department of Dental Science,
Ground Floor, Room Number-3,
No.21/1, Lakshmipura Main Road, Vidyaranyapura Post.
Bangalore
KARNATAKA
560097
India |
| Phone |
9845011615 |
| Fax |
|
| Email |
ashwinprabhu@dscds.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepa Subramanian |
| Designation |
CEO |
| Affiliation |
Syncretic Clinical Research Services Pvt. Ltd. |
| Address |
Syncretic Clinical Research Services Pvt. Ltd.
Department of Clinical Operations,
Manidweep,
3rd Floor, C-2, No.13,
Dynasty Layout Mariannapalya,
H.A. Farm (post), Hebbal
Bangalore
KARNATAKA
560024
India |
| Phone |
9972598010 |
| Fax |
|
| Email |
deepa@syncretic.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepa Subramanian |
| Designation |
CEO |
| Affiliation |
Syncretic Clinical Research Services Pvt. Ltd. |
| Address |
Syncretic Clinical Research Services Pvt. Ltd.
Department of Clinical Operations,
Manidweep,
3rd Floor, C-2, No.13,
Dynasty Layout Mariannapalya,
H.A. Farm (post), Hebbal
Bangalore
KARNATAKA
560024
India |
| Phone |
9972598010 |
| Fax |
|
| Email |
deepa@syncretic.in |
|
|
Source of Monetary or Material Support
|
| GURUNANDA,
6645 Caballero Blvd,
Buena Park, CA 90620 |
|
|
Primary Sponsor
|
| Name |
GURUNANDA |
| Address |
6645 Caballero Blvd, Buena Park, CA 90620 |
| Type of Sponsor |
Other [Manufacturer, Limited Company] |
|
|
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 |
| Dr Ashwin Prabhu |
Rajalakshmi Hospital |
Department of Dental Science,
Room number-3, No.21/1.,
Lakshmipura Main Road,
Vidyaranyapura Post
Bangalore
KARNATAKA |
9845011615
ashwinprabhu@dscds.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajalakshmi Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B954||Other streptococcus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CPC |
20 ml of CPC Oral Rinse administered orally twice daily for 8 weeks |
| Intervention |
Gurunanda Natural Oil Pulling Oral Rinse |
10 ml of Gurunanda Natural Oil Pulling Oral Rinse administered orally once a day for 8 weeks |
| Comparator Agent |
Placebo |
10 ml of placebo administered orally once a day for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult male or female subjects (age 18-60yrs)
2.Subjects with at least 24 teeth.
3.Subjects having gingival probing depth of less than 3mm.
4.Subjects having gingival index scores equal to 2 and in more than 10% of the sites.
5.Subjects having plaque index scores equals to 2 and in more than 10% of the sites.
6.Subjects with no history of hypersensitivity reactions.
7. Able to communicate adequately with the investigator and to comply with the requirements for the entire study.
8. Subjects should not have history of periodontal therapy one month prior to screening.
9. Patient should be able to give written informed consent prior to participating in the study. |
|
| ExclusionCriteria |
| Details |
Subjects who have used antibiotics, antimicrobials, steroidal anti- inflammatory drugs, desensitizing toothpaste and NSAIDs within one month prior to screening.
2. Concomitant diseases (i.e. cancer, kidney diseases, liver diseases, neurological diseases, psychiatric diseases, blood disorders, gastrointestinal diseases).
3. Subjects with systemic conditions like diabetes, gastritis; oral diseases such as advanced periodontitis, frank dental caries, mucosal lesions.
4. Subjects with history of smoking or chewing tobacco.
5. Subjects with orthodontic appliances.
6. Hypersensitivity to any components of the investigational product.
7. Pregnancy and breastfeeding women.
8. Participation in concomitant interventional clinical study during the previous 30 days. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Reduction of Modified gingival Index.
2. Reduction of Plaque Index. |
Screening week 4, 8 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Reduction of cariogenic oral microflora.
2.In achieveing a significant reduction in CFUs in gram positive.
3.In achieveing a significant reduction in CFUs in gram negative.
4.Improvement of clinical oral dryness score (CODS).
5.Enhancement of organoleptic scoring scale (OSS).
6.Improvement VITA shade scale.
7.Compliance and tolerability.
8.Overall treatment satisfaction questionnaire. |
Baseline week 4, 8 |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
Final Enrollment numbers achieved (Total)= "66"
Final Enrollment numbers achieved (India)="66" |
|
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
06/07/2024 |
| Date of Study Completion (India) |
23/09/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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 is a single centric study which will be conducted in a clinical facility with EC registered, with CDSCO. Subjects who are diagnosed with Gingivitis will be recruited into this trial after all the inclusion and exclusion criterias are fulfilled. This study is randomized 3 arm parallel group study. 66 subjects will be recruited into this trial. one arm will be active, second arm will be a comparator and the third arm will be placebo. This is a single blind study. The duration of this study is for 8 weeks with 4 visits.The objective of this trial is evaluate the effectiveness and safety of active when compared to comparator and placebo.
The study outcome are; reduction of modified gingival, plaque index, gram positive and gram negative microbes, reduction of s mutants, improvement of teeth shade, oral dryness score and organoleptic score.
Type of study: randomised, placebo controlled, single blind and 3 arm study. |