Post Marketing Study to Evaluate the Efficacy of Scigates Foam Mouth Sanitizer 2 in 1 Toothpaste and Mouthwash in Tooth Whitening and Treating Tooth Sensitivity in a Control Group Using Standardized Methods and Criteria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Reduction in Tooth Sensitivity
研究概览
简要总结
This study evaluates the effectiveness of Scigates foam mouth sanitizer 2 in 1 toothpaste and mouthwash in reducing tooth sensitivity and improving tooth whitening compared to Lacalut® White & Repair toothpaste. Participants will be randomly assigned to either the Scigates group or the Lacalut control group and will use the assigned product three times daily for 8 weeks. Tooth sensitivity and dental staining will be assessed at multiple time points using standardized clinical scales. Safety will also be monitored throughout the study.
详细描述
This study is a randomized, parallel-group, controlled post-marketing clinical trial designed to evaluate the efficacy and safety of Scigates foam mouth sanitizer 2 in 1 toothpaste and mouthwash compared to Lacalut® White & Repair toothpaste in reducing tooth sensitivity and improving tooth whitening.
Healthy adult participants aged 18 to 65 years with mild to moderate tooth staining and self-reported tooth sensitivity were enrolled and randomly assigned to either the test group, receiving Scigates foam mouth sanitizer 2 in 1 toothpaste and mouthwash, or the control group, receiving Lacalut® White & Repair toothpaste. Participants used the assigned product three times daily for a period of 8 weeks according to standardized instructions.
A total of 57 participants were enrolled. The study was conducted as an exploratory post-marketing investigation and was concluded at this sample size to provide preliminary estimates of treatment effects, variability, and feasibility, which may inform the design and statistical powering of future larger-scale confirmatory studies.
Efficacy was assessed using validated clinical measures. Tooth sensitivity was evaluated using the Schiff Cold Air Sensitivity Scale, and dental extrinsic staining was assessed using the Modified Lobene Stain Index. Assessments were conducted at baseline and at weeks 1, 2, 4, and 8 to monitor changes over time.
Safety was evaluated throughout the study by recording adverse events and conducting clinical assessments. Participants were instructed to avoid the use of other dental treatments during the study period unless approved by the investigator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female participants aged 18 to 65 years
- •Individuals with mild to moderate tooth staining
- •Individuals with self-reported tooth sensitivity to hot, cold, sweet, or acidic stimuli
- •Ability and willingness to comply with all study procedures
- •Provision of written informed consent
排除标准
- •History of allergic reactions to any component of the study products
- •Presence of clinically significant allergic disease
- •Pregnant or lactating women
- •Women of childbearing potential not using an acceptable method of contraception
- •Individuals with severe tooth staining requiring professional treatment
- •Individuals who have received recent treatment for tooth discoloration
- •Individuals with severe periodontal disease requiring immediate intervention
- •Individuals with significant dental conditions such as active caries, periodontal disease, or ongoing orthodontic treatment
研究组 & 干预措施
Scigates Toothpaste Group
Participants assigned to this arm will use Scigates foam mouth sanitizer 2 in 1 toothpaste and mouthwash three times daily for 8 weeks according to standardized instructions.
干预措施: Scigates Foam Mouth Sanitizer 2 in 1 Toothpaste and Mouthwash (Drug)
Lacalut Toothpaste Group
Participants assigned to this arm will use Lacalut® White & Repair toothpaste three times daily for 8 weeks according to standardized instructions.
干预措施: Lacalut White and Repair Toothpaste (Drug)
结局指标
主要结局
Reduction in Tooth Sensitivity
时间窗: Baseline, Week 1, Week 2, Week 4, and Week 8
Tooth sensitivity will be assessed using the Schiff Cold Air Sensitivity Scale. This is a 4-point ordinal scale ranging from 0 to 3, where: 0 = No response to air stimulus (best outcome) 1. = Response to air stimulus without request to discontinue 2. = Response with request to discontinue or movement away 3. = Painful response with request to discontinue (worst outcome) Interpretation: Lower scores indicate less tooth sensitivity (better outcome), while higher scores indicate greater sensitivity (worse outcome). Assessments will be performed at Baseline, Week 1, Week 2, Week 4, and Week 8.
Reduction in Dental Extrinsic Staining
时间窗: Baseline, Week 1, Week 2, Week 4, and Week 8
Dental extrinsic staining will be assessed using the Modified Lobene Stain Index (MLSI). This index evaluates both extent and intensity of staining, each scored on a scale from 0 to 3: Extent of Staining (0-3): 0 = No stain 1. = Up to 1/3 of surface stained 2. = 1/3 to 2/3 of surface stained 3. = More than 2/3 of surface stained Intensity of Staining (0-3): 0 = No stain 1. = Light stain 2. = Moderate stain 3. = Heavy stain Scores from extent and intensity (for specified teeth) are summed to generate a composite score, with a possible range from 0 to 12. Interpretation: Lower scores indicate less staining (better outcome), while higher scores indicate more severe staining (worse outcome). Stain assessment will be performed on the labial surface of the upper left central incisor and upper left canine (or right counterparts if needed) at Baseline, Week 1, Week 2, Week 4, and Week 8.
次要结局
未报告次要终点
研究者
Prof. Mayyas Al-Remawi
University Vice President and Professor of Pharmaceutics and Pharmaceutical Technology
University of Petra