Evaluation of an Experimental Mouth Rinse Device for Relieving Dentinal Hypersensitivity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Mean Tactile Sensitivity Score at Week 2
研究概览
简要总结
This study is for people with sensitive teeth and involves going to the dentist for 4 visits over 6 weeks. At each visit the dentist will look at the mouth, teeth, tongue and gums of subjects, and check for sensitive teeth.
During the first 2 weeks, participants will brush their teeth two times a day with the fluoride toothpaste provided.
Then, if they qualify to continue in the study, participants will be assigned to a treatment group. All the groups will get toothpaste currently sold on the market, and one group will get a mouthwash with an experimental ingredient to use as well. Subjects will have an equal chance of being assigned to any one of the three groups.
For the next 4 weeks, subjects will use their assigned products according to the directions provided. At Visit 1 subjects will be supervised while they brush their teeth to ensure they understand the directions. They will also have supervised use of the product at Visit 2.
We will see if the mouthwash helps to reduce tooth sensitivity during the study.
详细描述
This study will consist of run-in and treatment phases. To qualify for the study, subjects must meet the inclusion/exclusion criteria and return tactile sensitivity scores within protocol-specified parameters at both the screening and baseline visits.
Run-in will consist of a 2-week period during which subjects will use a sodium fluoride dentifrice. At the start of the first phase, subjects will attend a Screening Visit. They will participate in the informed consent process, complete a medical/dental history, and be evaluated for tactile sensitivity to Yeaple probe and response to a cold air stimulus.
Subjects who qualify through screening will begin a run-in period that will last approximately two weeks. The run-in period will be followed by a Baseline visit. Subjects who continue to qualify through Baseline will be randomized to one of three treatment groups.
During the four-week treatment period, all subjects will brush their teeth twice daily for at least one minute in their usual manner, with their assigned toothpaste. After brushing, subjects assigned to the mouth rinse group will rinse with water, and then rinse with 10 mL of the experimental mouth rinse for 60 seconds.
The study duration is approximately six weeks with each subject visiting the clinical site six times.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Good general and oral health without any known allergy to commercial dental products or cosmetics
- •Evidence of a personally signed and dated informed consent document indicating the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial
- •Willingness to use the assigned products according to instructions, availability for appointments, and likelihood of completing the clinical trial
- •Dental condition appropriate for inclusion in the trial according to protocol-specified parameters and the professional opinion of the investigator
- •Adequate oral hygiene (i.e. brush teeth daily and exhibit no signs of oral neglect
排除标准
- •Medical condition or history, or use of drugs or treatments that could possibly compromise the safety of the research subject or the interpretation of results, per protocol or in the opinion of the investigator
- •Use of home-care bleaching, whitening products or professional bleaching treatment within a protocol-specified time period
- •Use of desensitizing agents within a protocol-specified time period
- •Participation in a dental clinical trial involving oral care products within a protocol-specified time period
研究组 & 干预措施
Mouth Rinse
Twice daily for 28 days, brush in usual manner for at least one minute using at least a one-inch strip of Fluoride Toothpaste provided. Rinse with water after brushing teeth. Then rinse for 60 seconds with 10 mL of the experimental Mouth Rinse 12027-033 (KOX).
干预措施: Mouth Rinse (Device)
Mouth Rinse
Twice daily for 28 days, brush in usual manner for at least one minute using at least a one-inch strip of Fluoride Toothpaste provided. Rinse with water after brushing teeth. Then rinse for 60 seconds with 10 mL of the experimental Mouth Rinse 12027-033 (KOX).
干预措施: Fluoride Toothpaste (Drug)
Fluoride Toothpaste
Twice daily for 28 days, brush in usual manner for at least one minute using at least a one-inch strip of the Fluoride Toothpaste (NEG) provided.
干预措施: Fluoride Toothpaste (Drug)
Potassium Nitrate Toothpaste
Twice daily for 28 days, brush in usual manner for at least one minute using at least a one-inch strip of the Potassium Nitrate Toothpaste (POS) provided.
干预措施: Potassium Nitrate Toothpaste (Drug)
结局指标
主要结局
Mean Tactile Sensitivity Score at Week 2
时间窗: 2 weeks
Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.
Mean Tactile Sensitivity Score at Week 4
时间窗: 4 weeks
Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.
次要结局
- Mean Tactile Sensitivity VAS Score at Week 2(2 weeks)
- Mean Tactile Sensitivity VAS Score at Week 4(4 weeks)
- Mean Cold Air Stimulus VAS Score at Week 2(2 weeks)
- Mean Cold Air Stimulus VAS Score at Week 4(4 weeks)