Prospective, open label, two-group, comparative clinical study to evaluate the effectiveness of a test product (i.e., Toothpaste containing Potassium Nitrate, Sodium fluoride, Sodium monofluorophosphate) on subjects with dentinal hypersensitivity.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- For Group 1
研究概览
简要总结
This is a prospective, open label, two-group, comparative clinical study to evaluate the effectiveness of a test product (i.e., Toothpaste containing Potassium Nitrate, Sodium fluoride, Sodium monofluorophosphate) on subjects with dentinal hypersensitivity.
The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent from the subjects.
All eligible subjects will undergo dental assessment and subjective assessment. Safety will be assessed throughout the study by monitoring adverse events.
Simultaneously, a small subgroup comparative analysis will also be performed to understand if the leave on technique provides a faster relief from Dentinal Hypersensitivity as compared to only brushing.
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
- •Males and Non-pregnant (self-declared)/Non-Lactating female subjects of age 18 to 60 years (both inclusive) at the time of consent.
- •Subjects having good general health as determined by the Investigator based on medical history and vital signs.
- •Subjects with localized and generalized dentinal hypersensitivity (preferably with equal number of localized and generalized DH in each group) 4) Subjects with mild to moderate dental hypersensitivity (tested by thermal testing).
- •Subjects complaining of dentinal hypersensitivity following a cold stimulus such as ice cream, iced drink, or a rapid jet of cool air to a particular tooth or teeth.
- •Subjects with eroded/damaged enamel (Grade 2 – 3 as per Ordinal scale for severity of dental erosion).
- •Subjects who are willing to participate in the study and give a signed consent.
- •Subjects should be willing and able to follow the study protocol to participate in the study.
排除标准
- •Pregnant or breastfeeding or planning pregnancy during the study period.
- •Subjects with orthodontic bands.
- •Subjects with partial removable dentures and fixed partial dentures.
- •Subjects having tumor(s) of the soft or hard tissues of the oral cavity.
- •Subject with advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone) 6) Subjects with history of treatment for dentin hypersensitivity 7) Poor periodontal condition 8) Subject who has used antibiotics any time during the one month prior to start of the study.
- •Subjects who consume alcohol.
- •Subjects smoking cigarette or consume any other form of tobacco.
- •Participation in a similar clinical study within the previous 30 Days.
- •Any other condition which could warrant exclusion from the study, as per the investigator’s discretion.
结局指标
主要结局
For Group 1
时间窗: baseline (30 mins before direct product application), 30 secs (+5 secs) after completion of brushing. | Day 15 (+ 02 days), Day 30 (+ 02 days) and Day 60 (+ 02 days) after 30 secs (+5 secs) of completion of brushing.
1.To assess the effect of test product in providing relief in dentinal hypersensitivity by thermal testing using hot gutta percha and cold spray for absent, mild, moderate or severe response recorded by the dentist at
时间窗: baseline (30 mins before direct product application), 30 secs (+5 secs) after completion of brushing. | Day 15 (+ 02 days), Day 30 (+ 02 days) and Day 60 (+ 02 days) after 30 secs (+5 secs) of completion of brushing.
2.To assess the effect of test product on self-perceived sensitivity by subjects using visual analog scale (VAS) at
时间窗: baseline (30 mins before direct product application), 30 secs (+5 secs) after completion of brushing. | Day 15 (+ 02 days), Day 30 (+ 02 days) and Day 60 (+ 02 days) after 30 secs (+5 secs) of completion of brushing.
次要结局
- For Group 1(To assess the effect of test product in terms of enamel protection by grading erosion using Ordinal scale for severity of dental erosion on buccal & lingual surfaces of maxillary anterior teeth)
- For Group 1(To assess Subjective evaluation questionnaires on dental hypersensitivity.)
- For Group 2(To assess the effect of test product in providing relief in dentinal hypersensitivity by thermal testing using hot gutta percha & cold spray for absent, mild, moderate or severe response recorded by the dentist at)
- For Group 2(To assess the effect of test product on self-perceived sensitivity by subjects using visual analog scale (VAS) at)
研究者
Dr Parth Joshi
Cliantha Research