None listed
Conditions
Interventions
Intervention1: Test Product A (gel): Mode of Usage: Apply a adequate amount (2-3 gram) of toothpaste on the
toothbrush bristles. Angle the toothbrush at 45 degrees to your gums and
gently move it ba
Sponsors
Dabur India 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) Participants are generally in good general health as determined from recent medical history. 5) Participants with an oral malodour during screening. 6) Participants having oral plaque and gingivitis. 7) Participants having 6 present upper front teeth. 8) Anterior teeth without restorations. 9) Participants who agree to discontinue the use of over-the-counter any teeth products throughout the study. 10) Participants who agree to refrain from the use of any oral products that may cause staining (chlorhexidine rinses, stannous fluoride toothpaste, etc.). 11) Participants who agree not to participate in any other oral/dental product studies during the study. 12) Participants who agree to return for all scheduled visits and follow study procedures. 13) Participants who are willing to complete all study procedures including study-related questionnaires and comply with study requirements.
Exclusion criteria
Exclusion criteria: 1) Participants who are undergoing product for gingivitis, caries, dental plaque and malodour. 2) Participants are present with fixed orthodontic appliances on the facial surfaces of the maxillary arch. 3) Participants have dental crowns, veneers or composite restorations on gradable maxillary anterior teeth (canine to canine) or mandibular anterior teeth. 4) Participants have any oral pathologies or gross neglect of home care requiring prompt product, 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 participants might be compromised. 5) Participants are present with any pre-existing oral or medical condition that the Investigator/designee determines may place the participants at increased health risk from study participation. 6) Participants have meaningful malocclusion that would impact product or ease of viewing/scoring anterior teeth. 7) Participants have teeth with severe or atypical intrinsic staining, such as that caused by tetracycline, fluorosis or hypo calcification. 8) Participants have any known allergies to over-the-counter oral hygiene/ products. 9) Participants have any known allergies to the study product ingredients. 10) The participants must 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) Participants who smoke and are pan eaters. 13) Participants having bridgework in their teeth and dentures which interrupt during evaluation. 14) Participants undergoing periodontal surgery within previous 6 months. 15) Participants undergoing product with antibiotics, anti-inflammatory, anticonvulsants, anti-histaminic, anti-depressant, anti-histaminic, sedatives, tranquilizers or daily analgesic drugs. 16) Participants overexposure to acidic by dietary and environment exposure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To evaluate the effectiveness of test products by assessing change in freshness evaluated using Tanita instrument and Organoleptic Assessment by dentist trained evaluator and/or dentist. 2.To evaluate the effectiveness of test products by assessing reduction in H2S releasing bacteria (fusobacterium nucleatum) in saliva and plaque sample evaluated using culture method. 3.To evaluate the effectiveness of test products by assessing change in plaque disposition evaluated using plaque index by dentist trained evaluator and/or dentis. 4.To evaluate the effectiveness of test products by assessing change in gingivitis evaluated using gingival index by dentist trained evaluator and/or dentist. 5.To evaluate the effectiveness of test products by assessing change in teeth whiteness evaluated using advanced VITA Easyshade V and Classic Vita Shade Guide by dentist trained evaluator and/or dentist.Timepoint: From baseline on Day 01 before product usage to post product assessments on Day 01 at T1 minutes, T30 minutes, T12 hours, on Day 14 ( 2 Days) before product usage and post usage at T1 minutes and on Day 30 ( 2 Days) From baseline on Day 01 before and after product usage at T1 minutes and on Day 30 ( 2 Days). From baseline on Day 01 before product usage to post product assessments on Day 01 at T1 minutes, T30 minutes and T12 hours, on Day 14 ( 2 Days) before product usage and post usage at T1 minutes and on Day 30 ( 2 Days) . From baseline on Day 01 before product usage to post product assessments on Day 01 at T1 minutes, T30 minutes and T12 hours, on Day 14 ( 2 Days) before product usage and post usage at T1 minutes and on Day 30 ( 2 Days). From baseline on Day 01 before product usage to post product assessments on Day 01 at T1 minutes, T30 minutes and T12 hours, on Day 14 ( 2 Days) before product usage and post usage at T1 minutes and on Day 30 ( 2 Days) . | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effectiveness of test products by assessing change in overall oral hygiene from baseline to post-product usage, within each product arm and between product arms.Timepoint: from baseline on Day 01 before product usage to post product assessments on Day 01 at T1 minutes, T30 minutes and T12 hours, on Day 14 post usage at T1 minutes and Day 30 ( 2 Days) post usage at T1 minutes assessed within each product arm and across product arms.;To evaluate the effectiveness of test products by assessing change in dental carries evaluated using International Caries Detection and Assessment System (ICDAS) by dentist trained evaluator and/or dentistTimepoint: From baseline on Day 01 before product usage to post product assessments on Day 01 at T1 minutes, T30 minutes and T12 hours, on Day 14 ( 2 Days) before product usage and post usage at T1 minutes and on Day 30 ( 2 Days) .;To evaluate the effectiveness of test products by assessing change in plaque induced gingivitis evaluated using Gingival Bleeding Index (GBI) by dentist trained evaluator and/or dentist.Timepoint: From baseline on Day 01 before product usage to post product assessments on Day 01 at T1 minutes, T30 minutes and T12 hours, on Day 14 ( 2 Days) post usage at T1 minutes and Day 30 ( 2 Days).;To evaluate the effectiveness of test products by assessing change in tooth surface temperature from cooling effect evaluated using thermal imaging cameraTimepoint: From baseline on Day 01 before product usage to post product assessments on Day 01 at T1 minutes, T30 minutes and T12 hours, on Day 14 ( 2 Days) before product usage and post usage at T1 minutes and on Day 30 ( 2 Days);To evaluate the effectiveness of test products by assessing change in salivary pH evaluated using pH paper stripTimepoint: From baseline on Day 01 before product usage to post product assessments on Day 01 at T1 minutes, T30 minutes and T12 hours, on Day 14 ( 2 Days) before product usage and post usage at T1 minutes and on Day 30 ( 2 Da | — |
Countries
India
Contacts
Public ContactDr Maheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed