A clinical study to evaluate teeth whitening effectiveness of a new mouthwash

Phase 2

Recruiting

Conditions: Disorder of teeth and supporting structures, unspecified,

Registration Number: CTRI/2025/03/082282

Lead Sponsor: GURUNANDA

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 120

Inclusion Criteria

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.

Exclusion Criteria

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.
15.Presence of orthodontic appliances, except for removable retainers.
16.Signs of advanced enamel wear, dentin exposure, or tooth fractures.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement of tooth whitening	Screening, week 2,4 and 6.

Secondary Outcome Measures

Name	Time	Method
1) Reduction of surface stains	2) Prevention of new stain

Trial Locations

Locations (1): Rajalakshmi Hospital and Research Center
🇮🇳
Bangalore, KARNATAKA, India
Rajalakshmi Hospital and Research Center
🇮🇳Bangalore, KARNATAKA, India
Dr Ashwin Prabhu
Principal investigator
9845011615
ashwinprabhu@dscds.edu.in