A clinical study to understand the effectivenss of an oral mouthwash in teeth whitening.

Phase 2

Not yet recruiting

Brief Summary: This is a double blind, randomized, placebo controlled study. This study is to evaluate the teeth whitening effectiveness and safety of active when compared to 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 tooth shade of more than A2 will be randomised into the trial. The study population is 100 subjects, 50 subjects on active and 50 subjects on placebo. The duration of the study is 4 weeks from baseline with 4 visits.

The study outcome are;

Primary outcome - Improvement of teeth whitening.

Secondary outcome - Safety assessment

Study design - Randomized, double blind, placebo controlled study.

Recruitment & Eligibility

Inclusion Criteria

Adult male or female subjects (age 18-65 yrs), 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.Tooth shade 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 the 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.

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.

Primary Outcome Measures

Name	Time	Method
Improvement in teeth whitening	Screening,Day 0, week 2, week 4

Secondary Outcome Measures

Name	Time	Method
1.Physical Examination	2.Oral examination.

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