CTRI Number |
CTRI/2025/03/082282 [Registered on: 13/03/2025] Trial Registered Prospectively |
Last Modified On: |
30/05/2025 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
|
A clinical study to evaluate teeth whitening
effectiveness of a new mouthwash |
Scientific Title of Study
|
A double blind, single centric, randomized 3 arm parallel study to evaluate the efficacy and safety of Gurunanda Whitening mouthwash with enzymes in the management of improvement in tooth shade, reduction of surface stains and prevention of new stains
|
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Ashwin Prabhu |
Designation |
Principal Investigator |
Affiliation |
Rajalakshmi Hospital and Research Center. |
Address |
Rajalakshmi Hospital and Research Center. 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
KARNATAKA 560024 India |
Phone |
9972598010 |
Fax |
|
Email |
deepa@syncretic.in |
|
Source of Monetary or Material Support
|
GURUNANDA
6645, Caballero Blvd, Buena Park, California, Pin code - 90620
United States of America |
|
Primary Sponsor
|
Name |
GURUNANDA |
Address |
6645, Caballero Blvd, Buena Park, California, Pin code - 90620
United States of America |
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 and Research Center |
Department of Dental Science, Ground Floor, Room Number-3, No.21/1, Lakshmipura Main Road, Vidyaranyapura Post
Bangalore
KARNATAKA Bangalore KARNATAKA |
9845011615
ashwinprabhu@dscds.edu.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Rajalakshmi Hospital Institutional Ehtics 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
Modification(s)
|
Type |
Name |
Details |
Intervention |
Gurunanda Whitening mouthwash with enzymes |
20 ml mouthwash twice a day orally for 6 weeks |
Comparator Agent |
Placebo |
20 ml mouthwash twice a day orally for 6 weeks |
Comparator Agent |
Therabreath Whitening Fresh Breath Mouthwash |
20 ml mouthwash twice a day orally for 6 weeks |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1.Adult male or female subjects
2.Subjects with atleast 20 permanent teeth excluding third molar
3.Non-smokers with good oral and general health
4.All 6 anterior maxillary teeth free of caries or restorations
5.Subjects having teeth shades of A2 or darker with no cervical lesions or prosthodontics treatments and with no periodontal
disease
6.Subjects should not use mouthwash 1 week prior to screening and during the whole course of the study
7.All subjects should use same toothpaste during the entire course of the study
8.Able to communicate adequately with the investigator and to comply with the requirements for the entire study
9.Subjects should not have history of periodontal therapy one month prior to screening
10.Patient should be able to give written informed consent prior to participating in the study
11.Will not use other teeth whitening product(s) during the duration of the study |
|
ExclusionCriteria |
Details |
1.Individuals with discolored teeth (eg:- tetracycline and fluorosis).
2.Subjects having intrinsic stains.
3.Steroidal anti-inflammatory drugs, NSAIDs one month prior to screening.
4.Concomitant diseases (i.e. cancer, kidney diseases, liver diseases, neurological diseases, diabetes, gastritis psychiatric diseases, blood disorders, gastrointestinal diseases).
5.Subjects with known sensitivity or oral mucosal tissue reaction to any components of the investigational product.
6.Pregnancy and breastfeeding women.
7.Participation in concomitant interventional clinical study during the previous 30 days.
8.Active oral infections, untreated cavities, or periodontal disease.
9.Presence of restorations on front teeth (e.g., crowns, veneers, or composite fillings) that could affect whitening results.
10.Recent dental procedures (e.g., scaling, polishing, or whitening) within the last 4 weeks.
11.Concurrent use of whitening products or treatments within the past 4 weeks.
12.Heavy tobacco use, including cigarettes, cigars, or smokeless tobacco.
13.Consumption of stain-causing substances (e.g., red wine, coffee, tea) that cannot be avoided during the study period.
14.Use of medications that may affect tooth discoloration (e.g., tetracyclines, chlorhexidine).
15.Presence of orthodontic appliances, except for removable retainers.
16.Signs of advanced enamel wear, dentin exposure, or tooth fractures.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Pharmacy-controlled Randomization |
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Improvement of tooth whitening |
Screening, week 2,4 and 6. |
|
Secondary Outcome
|
Outcome |
TimePoints |
1) Reduction of surface stains
2) Prevention of new stain |
Screening, week 2,4 and 6. |
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
|
30/05/2025 |
Date of Study Completion (India) |
21/07/2025 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="2" Days="15" |
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
|
This is a randomized, double blind, placebo controlled, 3 arm parallel study in single center.
This study is to assess the teeth whitening effectiveness and safety of active when compared to comparator and placebo. Study is planned to be conducted in a clinical site where EC is registered with CDSCO. Study will be only initiated after receiving CTRI registration number. Based on inclusion/exclusion criteria subjects with teeth shade of more than A2 will be randomised into the trial. The study population is 120 subjects, 40 subjects on active, 40 subjects on comparator and 40 subjects on placebo. The duration of the study is 6 weeks from baseline with 5 visits.
The study outcome are;
Primary outcome - Improvement of teeth whitening. Secondary outcome - Reduction of surface stain and Prevention of new stain.
Study design - Randomized, double blind, placebo controlled 3 arm study.
|