An Exploratory, Open-Label, Parallel, Two-Arm, Prospective, Interventional Study to Evaluate the Safety, Efficacy, and Tolerability of Two Different Teeth Whitening Products (Dream White Toothpaste and Teeth Whitening Serum) in Healthy Adults with Dark Tooth Color (A2 or Darker for toothpaste and B2, B3 or B4 for teeth whitening serum).

Purple Magic Teeth Whitening Serum: This clinical study was an exploratory, open-label, parallel, prospective, interventional investigation conducted to evaluate the safety, efficacy, and in-use tolerability of Purple Magic Teeth Whitening Serum in healthy adults with dark-shaded teeth. Registered with the Clinical Trial Registry of India (CTRI/2024/10/074766) on October 4, 2024, the study enrolled 40 subjects aged 18 to 55 years, with 32 successfully completing the study. Written informed consent was obtained from all participants after a detailed explanation of the study procedures, and copies of the consent forms were provided to the subjects. The study design included three visits: Visit 01 (Day 01), which involved screening, baseline evaluations, initial product application, and post-use assessment; and follow-up visits on Day 08 (+2 days) and Day 15 (+2 days). The primary objectives were to evaluate improvements in tooth whiteness and the reduction of extrinsic stains. Additionally, subjects completed a questionnaire assessing their perceptions of tooth color improvement, cleanliness, uniformity of tooth color, overall satisfaction, taste, and freshness after using the product.

Instrumental evaluations were conducted using the Vita Easyshade and Classic Vita Shade Guide (VITA Zahnfabrik H. Rauter GmbH & Co. KG) to measure tooth color improvement precisely. Dentists assessed extrinsic stains using the Lobene Stain Index to ensure thorough evaluation of stain reduction. All raw data were meticulously reviewed, and statistical analyses were performed using IBM® SPSS® (Version 29.0.1.0(171)) and Excel, with a 5% level of significance ensuring robust interpretation. Purple Magic Teeth Whitening Serum is uniquely formulated to enhance tooth whiteness and overall dental health. Its active ingredients include Nano Hydroxyapatite, which restores and strengthens enamel; Bromelain and Papain enzymes, which break down stains and plaque while providing mild exfoliation; Apple and Peach fruit extracts, which promote dental health; Peppermint and Spearmint, which enhance oral hygiene and provide a fresh sensation; and ImerCare® PerlWhite19, which visibly whitens teeth and aids in color correction.

The study demonstrated significant improvements in teeth whiteness, color uniformity, and reduction of extrinsic stains. Objective results showed a marked increase in the L* value, indicating a substantial enhancement in teeth whiteness from baseline to Day 15. Subjects reported high satisfaction with the product’s whitening effects, taste, and fresh sensation. No adverse effects were observed, confirming the safety of the product for healthy individuals. In conclusion, Purple Magic Teeth Whitening Serum proved to be a safe and effective solution for improving teeth whiteness, reducing stains, and enhancing overall tooth appearance. Its innovative formulation and demonstrated efficacy position it as a valuable addition to oral health care regimens for individuals seeking effective teeth whitening and stain reduction.

Dream White Toothpaste : This clinical study was designed as an exploratory, open-label, parallel, prospective, interventional investigation to assess the safety, efficacy, and in-use tolerability of Dream White Toothpaste in healthy adults with dark-shaded teeth. The study was registered with the Clinical Trial Registry of India (CTRI/2024/10/074766) on October 4, 2024. A total of 32 subjects, aged 18 to 55 years were enrolled, with 30 subjects completing the study. Written informed consent was obtained from all participants after a comprehensive explanation of the study procedures, and copies of the consent forms were provided.

The study design included three scheduled visits, Visit 01 involved screening, baseline assessments, test product application, and post-use evaluation. Follow-up assessments were conducted on Day 30 ±2 days and Day 60 ±2 days to monitor key safety and efficacy parameters, including improvements in teeth whiteness and reductions in extrinsic stains. Participants completed questionnaires evaluating changes in tooth color, cleanliness, uniformity, and overall satisfaction with the test product.

Tooth color improvements were objectively measured using instrumental evaluations with Vita Easyshade V and the Classic Vita Shade Guide (VITA Zahnfabrik H. Rauter GmbH & Co. KG Spitalgasse 3, V512bLE). Extrinsic stain reduction was assessed through dentist evaluations using the Lobene Stain Index, ensuring a comprehensive analysis of stain reduction. All raw data were reviewed, and statistically analysed using IBM® SPSS® (Version 29.0.1.0(171)) and Microsoft® Excel, with a 5% level of significance ensuring rigorous data interpretation.

The study findings indicate a progressive improvement in teeth whiteness & a reduction in stain intensity over the study period. No treatment-related adverse effects were observed, suggesting that Dream White Toothpaste is safe for regular use. The results support that the toothpaste may contribute to improved tooth whiteness and effective stain reduction, with favourable tolerability and overall participant satisfaction.