A Real-World Evidence Study Evaluating Oral Health Related Quality of Life With Use of a Calcium Sodium Phosphosilicate Anti-Sensitivity Dentifrice for Dentin Hypersensitivity Management
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- HALEON
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Change From Baseline in DHEQ Total Score at Week 24
研究概览
简要总结
The aim of this study is to evaluate the impact of a commercially available desensitizing dentifrice containing 5 percent (%) Calcium sodium phosphosilicate (CSPS) on oral health related quality of life (OHrQoL) in a DH (Dentin Hypersensitivity) population in a real-world setting.
详细描述
This will be a decentralized, prospective, 24-week, monadic design, open label, study in a DH population. The study will evaluate changes in OHrQoL in participants with self-reported DH symptoms. OHrQoL will be measured using a validated questionnaire, the Dentin Hypersensitivity Experience Questionnaire (DHEQ-48), completed by study participant. Sufficient numbers will be screened to enroll approximately 500 participants to ensure approximately 400 evaluable participants complete the entire study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Participant who has provided consent indicating they have been informed of all pertinent aspects of the study.
- •All genders who, at the time of screening, are aged 18 to
- •Participant who is able to independently complete all activities on their smart devices
- •Participant who has tooth sensitivity (self-reported symptoms).
排除标准
- •Participants whose tooth sensitivity could be caused by other factors or clinical pathology than DH, as self-reported on the screening questionnaire, which include:
- •Participant who has been/is on multiple prescription medications to treat severe acid reflux on a regular basis or has had surgery for acid reflux.
- •Participant with full or partial denture.
- •Participant who has undergone treatment for periodontal or gum disease within 6 months of screening or is currently undergoing treatment for periodontal or gum disease.
- •Participant who has been informed by a Dental Health Care Professional (DHCP) that they have active periodontitis.
- •Participants who have been informed by a DHCP that they have active caries.
- •Participant with any chronic and/or severe painful health condition which lead to regular use of pain relief medications (more than 3 days a week).
- •Participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
研究组 & 干预措施
Test Toothpaste
Participants will be instructed to brush their teeth twice daily and not more than three times per day using test toothpaste, for 24 weeks.
干预措施: Calcium sodium phosphosilicate (CSPS) Toothpaste (Other)
结局指标
主要结局
Change From Baseline in DHEQ Total Score at Week 24
时间窗: Baseline and Week 24
The DHEQ is used to measure how DH affects participants quality of life. Section 2 has 34 questions in grouped into 5 domains (Restrictions, Adaptation, Social Impact, Emotional Impact, and Identity). Participants scored each question using a 7-point scale ranging from 1 to 7, where 1= strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. The total score will be derived from the sum of scores across all domains and it ranges from 34 to 238. A lower score indicates a better quality of life regarding DH. Change from Baseline will be calculated by subtracting the Baseline score from the score at Week 24.
次要结局
- Change From Baseline in DHEQ Restrictions Domain Score at Week 24(Baseline and Week 24)
- Change From Baseline in DHEQ Adaptation Domain Score at Week 24(Baseline and Week 24)
- Change From Baseline in Impact on Everyday Life Score at Weeks 4, 8, 12, 16, and 20(Baseline and Weeks 4, 8, 12, 16, 20)
- Change From Baseline in DHEQ Social Impact Domain Score at Week 24(Baseline and Week 24)
- Change From Baseline in DHEQ Identity Domain Score at Week 24(Baseline and Week 24)
- Change From Baseline in DHEQ Emotional Impact Domain Score at Week 24(Baseline and Week 24)
- Change From Baseline in Impact on Everyday Life Score at Week 24(Baseline and Week 24)
- Change From Baseline in DHEQ Total Score at Weeks 4, 8, 12, 16, and 20(Baseline and Weeks 4, 8, 12, 16, 20)
- Change From Baseline in DHEQ Restrictions Domain Score at Weeks 4, 8, 12, 16, and 20(Baseline and Weeks 4, 8, 12, 16, 20)
- Change From Baseline in Global Oral Health Score at Week 24(Baseline and Week 24)
- Change From Baseline in DHEQ Adaptation Domain Score at Weeks 4, 8, 12, 16, and 20(Baseline and Weeks 4, 8, 12, 16, 20)
- Change From Baseline in Effect on Life Overall Score at Week 24(Baseline and Week 24)
- Change From Baseline in DHEQ Emotional Impact Domain Score at Weeks 4, 8, 12, 16, and 20(Baseline and Weeks 4, 8, 12, 16, 20)
- Change From Baseline in DHEQ Social Impact Domain Score at Weeks 4, 8, 12, 16, and 20(Baseline and Weeks 4, 8, 12, 16, 20)
- Change From Baseline in DHEQ Identity Domain Score at Weeks 4, 8, 12, 16, and 20(Baseline and Weeks 4, 8, 12, 16, 20)
- Change From Baseline in Global Oral Health Score at Weeks 4, 8, 12, 16, and 20(Baseline and Weeks 4, 8, 12, 16, 20)
- Change From Baseline in Effect on Life Overall Score at Weeks 4, 8, 12, 16, and 20(Baseline and Weeks 4, 8, 12, 16, 20)
- Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains at Baseline and Week 24(Baseline and Week 24)
- Change From Baseline in Numeric Pain Rating Scale (NPRS) Score at Weeks 1, 2, 4, 8, 12, 16, 20 and 24(Baseline, Weeks 1, 2, 4, 8, 12, 16, 20 and 24)
- Satisfaction Numeric Rating Scale (NRS) Score at Week 24(Week 24)