Health Condition 1: K088- Other specified disorders of teethand supporting structures
Conditions
Interventions
Intervention1: SuperFresh Whitening Toothpaste: Sorbitol, Hydrated Silica, Aqua, Glycerine, Probiotics, Xylitol, Erythritol, Xanthan
Gum, Nano-Hydroxyapatite, Vitamin E, ImerCare PerlWhite 19, Sodium
Sponsors
Chipper Consumer Pvt Ltd Perfora
Eligibility
Inclusion criteria
Inclusion criteria: Healthy adult Participants in the age group of 18-60 years who prefer to improve teeth shade cosmetically and who would want to maintain oral hygiene and to comply with the study procedures. study procedures. Tooth shades: B2, D2, A2, C2, D3, A3, D4, B3, A3.5, B4, C3, A4, and C4. Gingivitis Severity: Participants must have a L e and Silness Gingival Index score greater than 1, indicating moderate to severe gingival inflammation. Dental Plaque Level: Participants must have a Turesky modification of the Quigley-Hein Plaque Index score greater than 1. Good general health with no systemic conditions affecting oral health. Presence of natural teeth with visible extrinsic stains or discoloration. Willingness to avoid other whitening treatments during the study period. Ability to provide informed consent. Compliance with study protocols, including scheduled visits and post-treatment care.
Exclusion criteria
Exclusion criteria: Tooth shades: A1, B1 and C1 Wearing orthodontic appliances like a clear aligner, retainer, and night guard/ braces. Participants with mal-aligned teeth and removable partial dentures Participants with chronic or aggressive periodontitis; who underwent recent whitening intervention Tobacco consumers, smokers and betel chewers. Participants who are pregnant or lactating. Participants with hypersensitivity to any of the test products. Participants with pre-existing tooth sensitivity Concurrent use of any other treatment for teeth whitening or sensitivity Concurrent participation in any other clinical trial or study involving teeth whitening or sensitivity assessment. Severe enamel defects or intrinsic discoloration unrelated to staining. Prior participation in a similar study within the past six months. Current use of medications causing tooth discoloration, such as tetracycline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess improvement in VITA shade (by using VITA Easy Shade Evaluate the efficacy of the product in preventing mouth odour, providing a sustained sensation of oral freshness for up to 12 hours, and maintaining fresh breath throughout the day, as well as promoting a clean and healthy oral environment . The assessment will be conducted by using Organoleptic Scoring Scale (OSS) and Assessment by Halimeter. 5- 3D master) scale over various time points. [Time Frame: Baseline, Day 30 and Day 60] Macpherson Stain Index Oral Hygiene Index Simplified (OHI-S) Dental Plaque will be assessed using Turesky modification of the Quigley Hein Plaque Index. Baseline, Day 30 and Day 60] Gingivitis scale using Loe and Silness Gingival Index. [Time Frame: Baseline, Day 30 and Day 60] Photographic assessment of oral cavity [Baseline & Day 60]Timepoint: Baseline, Day 30 and Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| Participants will be provided with a diary to monitor usage Page 9 of 45 Protocol No: SFW/07/25 Version: 1.1 OUTCOME Participant and Investigator feedback will be obtained using 5-point likert scale questionnaire Adverse event monitoringTimepoint: Baseline, Day 30 and Day 60 | — |
Countries
India
Contacts
Public ContactDr Gayathri Sivakumar
Ki3 Private Limited
Outcome results
None listed