Health Condition 1: K050- Acute gingivitis
Conditions
Interventions
Intervention1: SPLAT Lavendersept of Professional Series: Manufactured By/For: SKyStore Limited
Mode of Usage: Apply an adequate amount (2-3 gram) of toothpaste on the toothbrush bristles. Angle the
Sponsors
SkyStore 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) 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) Participants who are Pan/Gutka eaters, smokers and have extrinsic stain intensity score more than 1 in extrinsic stain index. 7) Participants having gingivitis. 8) Participants having 6 present upper front teeth. 9) Anterior teeth without restorations. 10) Participants who agree to discontinue the use of over-the-counter any teeth products throughout the study. 11) Participants who agree to refrain from the use of any oral products that may cause staining (chlorhexidine rinses, stannous fluoride toothpaste, etc.). 12) Participants who agree not to participate in any other oral/dental product studies during the study. 13) Participants who agree to return for all scheduled visits and follow study procedures. 14) 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 treatment for gingivitis, 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 having bridgework in their teeth and dentures which interrupt during evaluation. 13) Participants undergoing periodontal surgery within previous 6 months. 14) Participants undergoing product with antibiotics, anti-inflammatory, anticonvulsants, anti-histaminic, anti-depressant, anti-histaminic, sedatives, tranquilizers or daily analgesic drugs. 15) Participants overexposure to acidic by dietary and environment exposure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To evaluate the effectiveness of the test products by assessing change in Gingivitis from baseline to post-product usage, within each product arm and between product arms. 2.To evaluate the effectiveness of the test products by assessing change in teeth whiteness from baseline to post-product usage, within each product arm and between product arms. Timepoint: Baseline, T1 min, Day 28 | — |
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: Baseline, T1 min, Day 28;To evaluate the effectiveness of the test products by assessing change in gingival bleeding from baseline to post-product usage, within each product arm and between product arms.Timepoint: Baseline, T1 min, Day 28;To evaluate the effectiveness of the test products by assessing change in freshness from baseline to post-product usage. (Applicable for Arm 2)Timepoint: Baseline, T1 min, Day 28;To evaluate the effectiveness of the test products by assessing change in persistent extrinsic stains from baseline to post-product usage, within each product arm and between product arms.Timepoint: Baseline, T1 min, Day 28;To evaluate the effectiveness of the test products by assessing change in tooth sensitivity from baseline to post-product usage. (Applicable for Arm 1)Timepoint: Baseline, T1 min, Day 28;To evaluate the effectiveness of the test products by assessing change in subjective perception questionnaire from baseline to post-product usage, within each product arm and between product arms.Timepoint: Baseline, T1 min, Day 28;Safety will be determined by test product-emergent adverse events such as gum irritation, gum bleeding, taste alteration, dryness of mouth, burning sensation, and ulcers as assessed by the dentist trained evaluator and/or dentist. (Safety Objective)Timepoint: Baseline, T1 min, Day 28 | — |
Countries
India
Contacts
Public ContactDr Maheshvari Patel
NovoBliss Research Pvt. Ltd.
Outcome results
None listed