Health Condition 1: K055- Other periodontal diseases
Conditions
Interventions
Intervention1: Charcoal Gel toothpaste 1
: Mode of Application: 2-3 g twice daily, to be adequately applied on the toothbrush and brush the teeth for at least 2 minutes for better cleaning. Route of A
Sponsors
Dabur India Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1)Age: 18 to 55 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 Easyshade Advance 5.0), which was determined on the middle third of the vestibular surface of the maxillary lateral incisors by the Dentist. 6)Subjects who are Pan/Gutka eaters, smokers and have extrinsic stain intensity score more than 1 in extrinsic stain index. 7)Subjects having score of more than 0 in TANITA breath analyser. 8)Subjects having score of more than 1 in plaques index and gingival index. 9)Subjects with no tooth sensitivity during screening. 10)Subjects having 6 present upper front teeth. 11)No previous whitening treatments | products and no restorations (anterosuperior group). 12)Anterior teeth without restorations. 13)No cervical lesions, or dental pain. 14)Subjects who agree to discontinue the use of over-the-counter teeth whitening products throughout the trial. 15)Subjects who agree to discontinue the use of any other oral care product except the test products like mouth wash, oil pull, any medicated gargle, mouth sprays, any tooth gel or whitening chewing gums etc. throughout the trial. 16)Subjects who agree to refrain from the use of any oral products that may cause staining (chlorhexidine rinses, stannous fluoride toothpaste, etc.). 17)Agree not to participate in any other oral/dental product studies during the trial. 18)Agree to return for all scheduled visits and follow study procedures. 19)Subjects who are willing to complete all study procedures including study-related questionnaires and comply with study requirements. 20)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 are present with fixed orthodontic appliances on the facial surfaces of the maxillary arch. 3)Subjects have dental crowns, veneers or composite restorations on gradable maxillary anterior teeth (canine to canine) or mandibular anterior teeth. 4)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. 5)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. 6)Subjects have meaningful malocclusion that would impact treatment or ease of viewing/scoring maxillary anterior teeth. 7)Subjects have teeth with severe or atypical intrinsic staining, such as that caused by tetracycline, fluorosis or hypo calcification. 8)Subjects have any known allergies to over-the-counter oral hygiene/whitening products. 9)Subjects have any known allergies to the trial product ingredients. 10)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. 11)Any other condition which could warrant exclusion from the study, as per the investigator’s discretion. 12)Pregnant or breastfeeding or planning to become pregnant during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To evaluate the effectiveness of the test products in terms of change in whiteness and shine of the teeth and prevention of yellowing of teeth with regular use. 2.To evaluate the effectiveness of the test products in terms of change in extrinsic stains. 3.To evaluate the full coverage, powerful, gentle cleaning of teeth by test products in terms of plaque reduction and prevention of plaque formation with regular use. 4.To evaluate the full coverage, powerful, gentle cleaning of teeth by test products in terms of gingivitis reduction and prevents gingivitis with regular use. 5.To assess the effect of test product in improving the mild-moderate halitosis. Timepoint: From baseline reading i.e. Day 1 before test products usage to Day 1 after test products usage and brushing at T15mins, Day 03, Day 05 (only whitening), Day 07, Day 14 and on Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Subject perception questionnaires on the taste and fresh sensationTimepoint: After test product usage at 0 mins, 30 mins and 60 mins (±5 mins) on Day 1;To assess the effect of test products in providing protection against the effect of teeth sensitivity, acid erosion of tooth enamelTimepoint: From baseline reading i.e. Day 1 before test products usage to Day 1 after test products usage and brushing at T15mins, Day 03, Day 07, Day 14 and on Day 28;To assess the effect of test products in terms of change in color of the toothTimepoint: From baseline reading i.e. Day 1 before test products usage to Day 1 after test products usage and brushing at T15mins, Day 03, Day 07, Day 14 and on Day 28;To assess the effect of test products in terms of change in mal-odorTimepoint: From baseline reading i.e. Day 1 before test products usage to Day 1 after test products usage and brushing at T15mins, Day 03, Day 07, Day 14 and on Day 28;To assess the effectiveness of the test products through consumer perception questionnaireTimepoint: From baseline reading i.e. Day 1 before test products usage to Day 1 after test products usage and brushing at T15mins, Day 03, Day 07, Day 14 and on Day 28 | — |
Countries
India
Contacts
Public ContactMaheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed