Health Condition 1: K030- Excessive attrition of teeth
Conditions
Interventions
Intervention1: Step A: Pearl White Drops ââ?¬â?? Teeth Whitening Pen
Step B: PROTEETH Ultrasonic Toothbrush: Step A: Pearl White Drops ââ?¬â?? Teeth Whitening Pen
Hydrogen peroxide, Citrus Limon Pee
Sponsors
SkinTouch Beauty Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - To assess the whiteness of the teeth using dental shade guides. - To assess the change in the whiteness of the teeth by evaluating extrinsic stain using stain index - To assess the change in full coverage, powerful, gentle cleaning of the teeth by evaluating plaque reduction using plaque index and the reduction in gingivitis using the gingival indexTimepoint: A baseline reading on Day 1 before application to Day 1 after application and on Day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of teeth sensitivity and protection against the effect of acid erosion of tooth enamelTimepoint: A baseline reading on Day 1 before application to Day 1 after application and on Day 15;Incidence of an adverse event in the oral cavity of the test product if any will be assessed by the dentist along with self-reported by subjectsTimepoint: Throughout the study period;Subject perception questionnaires on the cleaning efficacy of PROTEETH ultrasonic toothbrush will be asked by study staffTimepoint: on Day 15 post usage;Subject perception questionnaires on the taste, fresh sensation, and cooling effect of Teeth Whitening Drops will be asked by study staffTimepoint: After usage at 0 mins, 30 mins and 60 mins on Day 1 post-application. | — |
Countries
India
Contacts
Public ContactMaheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed