Randomized Non-inferiority Trial of Nano-hydroxyapatite-Containing Toothpastes for Relief of Dentin Hypersensitivity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 2
- 主要终点
- Measurement of Cold Air Stimulus
研究概览
简要总结
Subjects will be enrolled into 3 balanced groups each using a different strength toothpaste. Dental hypersensitivity (DHS) will be assessed at study start, midway and study end.
详细描述
This study is a double-blind, randomized, placebo-and positive-controlled, stratified parallel group clinical trial. The three groups will be randomly assigned to use one of three test toothpastes having an identical base formulation but containing respectively either 0% nano-hydroxyapatite (HAP) (placebo), 15% nano-HAP or 5% KNO3 (positive control). All dental examinations for data collection will be conducted by the same Clinical Examiner.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females between the age of 20 and 80 years, of any socio-economic status
- •Diagnosed as having DHS, i.e. having at least one sensitive tooth with demonstrated cervical erosion/abrasion or gingival recession
- •Showing a sensitivity response to both tactile and cold air stimulus delivered by a Yeaple probe and a one-second blast of cold air respectively
- •Patients must be reliable, cooperative and of adequate intelligence to read and understand the rating scales and other study instructions
- •Patients must be able to read, comprehend, and sign the informed consent form
- •The teeth and sites to be tested should be on the buccal/labial surfaces of incisors, canines, premolars or molars where the affected sites are accessible
- •Teeth selected for testing should have a plaque index of ≤ 2
排除标准
- •The sensitive tooth is associated with concomitant oral pain due to any other condition such as soft-tissue lesions, tooth-ache ascribable to dental caries, tooth fracture, or cracked tooth syndrome, or pain due to other surgical procedures or injuries.
- •The sensitive tooth is associated with a periodontal abscess as diagnosed from an X-ray or clinical examination of the tooth
- •The sensitive tooth is associated with mobility >1
- •The sensitive tooth is associated with gum pain from gingivitis, occlusal trauma, thermal or chemical burns
- •Patients having pain from periodontal-related causes but not DHS
- •Previous professional desensitizing treatment
- •Patients using medication which could interfere with the perception of pain
- •Medical histories marked by chronic use of anti-inflammatory agents, daily analgesics, anticonvulsants, antihistamines, antidepressants, sedatives and/or other psychotropic drugs
- •Pregnancy or breastfeeding
- •Allergies and idiosyncratic responses to toothpaste ingredients
- •Eating disorders or conditions associated with vomiting
- •Systemic conditions that are etiologic or predisposing to DHS
- •Excessive dietary or environmental exposure to acids
- •The sensitive tooth was restored in the preceding three months
- •The sensitive tooth is an abutment tooth for fixed or removable prostheses
- •The sensitive tooth has extensive restoration or restorations extending into the test area
- •Patients below 20 years or above 80 years of age
结局指标
主要结局
Measurement of Cold Air Stimulus
时间窗: Week 0 (baseline), 4 weeks and 8 weeks
The primary efficacy outcome will be the decrease in cold air stimulus sensitivity (VAS score) from baseline to 8 weeks. Assessment of change in cold air sensitivity will be conducted using air delivered from a standard dental unit air syringe at room temperature (\~70°F±3°F)(\~21°C±2°C) and a pressure of 60psi (± 5psi). Assessment of sensitivity will be carried out using Visual Analog Scale (VAS). Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort.
次要结局
- Measurement of Tactile Stimulus(Week 0 (baseline), 4 weeks and 8 weeks)
研究者
Bennett Amaechi
Professor and Director of Cariology
The University of Texas Health Science Center at San Antonio