Evaluation of SuperFresh Whitening Toothpaste for Breath Freshness Efficacy and Whitening Effect in a Single-Arm Clinical Study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To assess improvement in VITA shade (by using VITA Easy Shade
研究概览
简要总结
This Phase 3, single-arm clinical study demonstrated that Superfresh Whitening Toothpaste formulated with nano-hydroxyapatite, probiotics, polyols, controlled abrasives, and essential oils, significantly improved dental aesthetics, breath freshness, and oral hygiene over a 60-day period in 30 healthy adults. Teeth-whitening efficacy was confirmed through VITA shade, delta E, and CIELAB values. The toothpaste produced an immediate and reproducible reduction in volatile sulfur compounds and organoleptic scores at all visits, with sustained effects up to 12 hours and cumulative improvement by Days 30 and 60. Oral hygiene markers including OHI-S, QHPI, and Gingival Index showed rapid and progressive improvement throughout the study duration. The product was well tolerated, with only mild, transient adverse events and no discontinuations. Participant feedback reflected high acceptability, with strong ratings for freshness, whitening, comfort, sensory attributes, and overall satisfaction. Overall, the findings confirm that Superfresh Whitening Toothpaste offers effective, safe, and well-tolerated whitening and oral-care benefits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •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 C
- •Gingivitis Severity: Participants must have a Löe 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
- •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.
排除标准
- •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.
结局指标
主要结局
To assess improvement in VITA shade (by using VITA Easy Shade
时间窗: Baseline, Day 30 and Day 60
Evaluate the efficacy of the product in preventing mouth odour,
时间窗: Baseline, Day 30 and Day 60
providing a sustained sensation of oral freshness for up to 12
时间窗: Baseline, Day 30 and Day 60
hours, and maintaining fresh breath throughout the day, as well as
时间窗: Baseline, Day 30 and Day 60
promoting a clean and healthy oral environment . The assessment
时间窗: Baseline, Day 30 and Day 60
will be conducted by using Organoleptic Scoring Scale (OSS) and
时间窗: Baseline, Day 30 and Day 60
Assessment by Halimeter.
时间窗: Baseline, Day 30 and Day 60
5- 3D master) scale over various time points. [Time Frame: Baseline,
时间窗: Baseline, Day 30 and Day 60
Day 30 and Day 60]
时间窗: Baseline, Day 30 and Day 60
Macpherson Stain Index
时间窗: Baseline, Day 30 and Day 60
Oral Hygiene Index Simplified (OHI-S)
时间窗: Baseline, Day 30 and Day 60
Dental Plaque will be assessed using Turesky modification of the
时间窗: Baseline, Day 30 and Day 60
Quigley Hein Plaque Index. Baseline, Day 30 and Day 60]
时间窗: Baseline, Day 30 and Day 60
Gingivitis scale using Loe and Silness Gingival Index. [Time Frame:
时间窗: Baseline, Day 30 and Day 60
Baseline, Day 30 and Day 60]
时间窗: Baseline, Day 30 and Day 60
Photographic assessment of oral cavity [Baseline & Day 60]
时间窗: Baseline, Day 30 and Day 60
次要结局
- Participants will be provided with a diary to monitor usage
研究者
Dr Anitha
Vinayaka Missions Sankarachariyar Dental college