A Dental study to check the tooth whitening effect and effectiveness of the ultrasonic toothbrush for teeth cleaning using a combination product ââ?¬Ë?Teeth Whitening Pen and PROTEETH Ultrasonic Toothbrushââ?¬â?¢ in Healthy Human Subjects with Darkar Tooth colour
- Conditions
- Health Condition 1: K030- Excessive attrition of teeth
- Registration Number
- CTRI/2022/07/044178
- Lead Sponsor
- SkinTouch Beauty Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 11
1) Age: 18 to 65 years (both inclusive) old at the time of consent.
2)� Sex: Healthy adult males and non-pregnant/non-lactating females.
3) Females of childbearing potential have a self-reported negative urine pregnancy test at the time of the screening visit and agree to follow an accepted method of birth control for the duration of the study such as condoms, foams, jellies, diaphragm, intrauterine device etc.
4)� Subjects are generally in good general health as determined from recent medical history.
5)� Tooth colour value of A2 or Darker (VITA scale), was determined on the middle third of the vestibular surface of the maxillary lateral incisors by the Dentist.
6) Subjects having 6 present upper front teeth
7)� No previous whitening treatments
8)� No restorations (anterosuperior group)
9)� Anterior teeth without restorations,
10)No cervical lesions, or dental pain
11)Subjects who agree to discontinue the use of over-the-counter teeth whitening products throughout the trial.
12) Agree not to participate in any other oral/dental product studies during the trial.
13) Agree to refrain from the use of any oral care products that may cause staining (chlorhexidine rinses, stannous fluoride toothpaste, etc.).
14)Agree to return for all scheduled visits and follow study procedures
15)Subjects who are willing to complete all study procedures including study-related questionnaires and comply with study requirements.
16)Subjects who can read, sign, and receive a copy of Informed Consent before on of study procedures.
1)Subjects who are undergoing treatment for gingivitis, periodontitis, or caries.
2)Subjects who have a presence of self-reported tooth sensitivity.
3)Subjects are present with fixed orthodontic appliances on the facial surfaces of the maxillary arch.
4)Subjects have dental crowns, veneers or composite restorations on gradable maxillary anterior teeth (canine to canine) or mandibular anterior teeth.
5)Subjects have any oral pathologies or gross neglect of home care requiring prompt treatment, including periodontal disease, as evidenced by purulent exudate, exposed root surfaces (generalized recession), tooth mobility, and/or other signs indicating that the integrity of the data collected for that subject might be compromised.
6)Subjects are present with any pre-existing oral or medical condition that the Investigator/designee determines may place the subject at increased health risk from study participation.
7)Subjects have meaningful malocclusion that would impact treatment or ease of viewing/scoring maxillary anterior teeth.
8)Subjects have teeth with severe or atypical intrinsic staining, such as that caused by tetracycline, fluorosis or hypo calcification.
9)Subjects have any known allergies to over-the-counter oral hygiene/whitening products or ingredients such as hydrogen peroxide, Xanthan Gum, Citrus Limon Peel Extract, Curcuma Longa Root Extract, Menthol, Mentha Viridis, etc.
10)Subjects have any known allergies to the trial product ingredients.
11)Subjects who are current smokers.
12)The subject must not have participated in a clinical study with oral care or oral hygiene within 4 weeks before the screening visit of this study.
13) Any other condition which could warrant exclusion from the study, as per the investigatorââ?¬•s discretion.
14)Pregnant or breastfeeding or planning to become pregnant during the study period.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method