NUPRO(r) Sensodyne Prophylaxis Paste With NovaMin(r) for the Treatment of Dentin Hypersensitivity.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 2
- 主要终点
- Immediate Sensitivity Relief. Air Blast Sensitivity.
研究概览
简要总结
The study is intended to verify through clinical measurement that the NUPRO Sensodyne Prophylaxis Paste with Novamin provides immediate sensitivity relief as well as extended relief up to 28 days.
详细描述
It is hypothesized that the prophy paste with NovaMin(r)will give patients immediate sensitivity relief, as well as sensitivity relief up to 4 weeks (28 days) after measurement.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Availability to complete in the 28 day duration of the study.
- •Two sensitive teeth which are not adjacent to each other and preferably in different quadrants and demonstrate cervical erosion, abrasion, and gingival recession.
- •qualifying response to tactile stimuli as defined by a score of </= 20 grams.
- •Qualifying response to air blast stimuli as defined by a score of >/= 1 on the Schiff Cold Air Sensitivity Scale.
- •Good general health with no known allergies to products being tested.
- •Use of a non-desensitizing dentifrice for 3 weeks prior to entry into the study.
- •Able to follow study procedures and instructions.
- •Must have a minimum of 10 natural evaluable teeth, excluding 3rd molars.
排除标准
- •Individuals who exhibit gross oral pathology
- •Females who may be pregnant or lactating or intending to become pregnant
- •Individuals who require anesthetic during scaling
- •Dental pathology which may cause pain similar to tooth sensitivity
- •Individuals with large amounts of calculus
- •Subjects with active infectious diseases such as hepatitis, HIV or tuberculosis
- •Any condition requiring antibiotic prophylaxis for dental treatment
- •Excessive gingival inflammation
- •Individuals who had their teeth cleaned within 30 days of the screening appointment
- •Individuals who have had a desensitizing treatment or tooth bleaching within 90 days of screening appointment.
- •Oral pathology, chronic disease, or history of allergy to test products
- •Advanced periodontal disease or treatment for periodontal disease (including surgery) within the past twelve months.
- •Sensitive teeth with mobility greater than one.
- •Teeth with extensive/defective restorations (including prosthetic crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures.
- •Regular use of sedatives, anti-inflammatory drugs, or analgesic
- •Participation in a desensitizing dentifrice study or regular use of a desensitizing dentifrice within the past 4 weeks.
- •Current participation in any other clinical study or receipt of an investigational drug within 30 days of the screening visit at the start of the study.
- •Personnel; a) An employee of the sponsor; b) A member or relative of the study site staff directly involved with the study.
- •Allergies to oral care products, personal care consumer products, or their ingredients.
- •Any subject who, in the judgment of the investigator, should not participate in the study.
结局指标
主要结局
Immediate Sensitivity Relief. Air Blast Sensitivity.
时间窗: Immediately after treatment.
Sensitivity measurements performed using a cold air blast and sensitivity scored on the four (4) point Schiff scale with 0 equal to no discomfort or awareness of sensitivity and 3 equal to severe pain from sensitive teeth. Score is reported as the change from baseline after treatment.
Immediate Sensitivity Relief. Tactile Sensitivity.
时间窗: Immediately after treatment.
Assessment of sensitivity via tactile stimulation immediately after treatment. Tactile sensitivity measured using a Yeaple probe recording tactile pressure in grams before nerve stimulation. Point of nerve stimulation identified by patient with a "yes" response as pressure is increased in 10 gram increments. Tactile sensitivity is reported as the change from baseline after treatment.
Adverse Events.
时间窗: Immediately after treatment to 28 days (+/- 2 days) post treatment.
Assessment of adverse events that may occur as a result of treatment (typically includes any kind of allergic reation to paste).
次要结局
- Extended Sensitivity Relief. Air Blast Sensitivity.(28 days (+/- 2 days) post treatment.)
- Extended Sensitivity Relief. Tactile Sensitivity.(28 days (+/- 2 days) post treatment.)