The Effect of Toothpastes Containing Ca-hydroxyapatite, Fluoroapatite, and Mg-Zn-hydroxyapatite on Dentin Hypersensitivity: a Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- change in dentin hypersensitivity score according to Shiff's index
研究概览
简要总结
This will be a double-blind, randomized, three-arm parallel groups study of the effect of toothpastes containing Ca-hydroxyapatite (HAP), Mg-Zn-hydroxyapatite (Zn-Mg-HAP), or fluoroapatite (FAP).
The aim of the study is to compare the effect of toothpastes containing Ca-hydroxyapatite (HAP), fluoroapatite (FAP), and Mg-Zn-hydroxyapatite (Mg-Zn-HAP) on dentin hypersensitivity associated with dental abrasion.
Materials and methods. Thirty consent patients aged 35-45 with dentin hypersensitivity associated with abrasion will be recruited for the study. The study will have 2 phases: preparatory phase (recruitment of the patients, standardization of their oral hygiene protocols, wash-out period, calibration of the researchers and training) and the main part (double-blind, randomized, parallel groups study of toothpastes effect). Patients will be randomly divided into 3 groups (group 1 - toothpastes with Ca-HAP, group 2 - toothpastes with Zn-Mg-HAP, group 3 - toothpastes with FAP). Clinical examination will be performed at the baseline, after 2 and 4 weeks, and will include patient's interview, oral hygiene level assessment (OHI-S), and dentin sensitivity testing (Shiff's index).
The null hypothesis is that there will be no statistically significant differences in dentin sensitivity level between the study groups.
详细描述
Background: Dentin hypersensitivity (DH) represents a sharp, short pain arising from exposed dentin in response to various stimuli which cannot be ascribed to any other form of dental defect or pathology. The use of toothpastes containing various HAP-formulations has become one of the most common methods for dentin hypersensitivity management. However, there is a paucity of literature concerning the comparison of the effect of different HAP-formulations.
This will be a double-blind, randomized, three-arm parallel groups study of the effect of toothpastes containing Ca-hydroxyapatite (HAP), Mg-Zn-hydroxyapatite (Zn-Mg-HAP), or fluoroapatite (FAP). The groups will include adults with DH diagnosed clinically.
The aim of the study is to compare the effect of toothpastes containing Ca-hydroxyapatite, fluoroapatite, and Mg-Zn-hydroxyapatite on dentin hypersensitivity in patients with dental abrasion. The sample size was determined according to the trial by Vano et al. (2017), where similar design was used. The power was set at 80%, alfa-level was set as 0.05, the means in the study groups were 2.65±0.68 and 1.72. The allocation ratio was equal to 1. The resultant target sample size comprised 10 participants in each group (7 participants according to sample size calculations plus 30% to account for possible drop-out), 30 patients total.
Subjects who meet all inclusion and exclusion criteria will be randomized on Baseline/Screening Visit in a 1:1:1 ratio to the Group 1, 2, or 3 in accordance with a computer-generated schedule prepared by a third-party person, who will not participate in the study.
The study is estimated to complete enrollment within 1 week from study initiation; however, enrollment will remain open until the study goal is met. The duration of this study for each subject will be a maximum of eight (8) weeks: 4 weeks - preparatory period and 4 weeks - intervention period.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged between 35 and 45 years
- •signed an approved Informed Consent Form, authorizing the participation in the trial and the use of the results of the trial for educational purposes and for the publication
- •the diagnosis of dentin hypersensitivity stated clinically
- •a premolar or first molar with an abrasive cervical defect of at least 1 millimeter, and not deeper than 1.5 millimeter, as measured by placing a periodontal probe into the deepest part of the cervical lesion; no mesial, distal or buccal restorations (to avoid confounding hypersensitivity)
- •a hypersensitivity score of 2 or higher on the Shiff scale with standardized air-blast stimulation
- •no other tooth in the same quadrant exhibiting hypersensitivity
排除标准
- •medical and pharmacotherapeutic histories that may compromise the protocol (pregnancy or breastfeeding, allergies to toothpastes ingredients, eating disorders)
- •systemic conditions that are etiologic to dentin hypersensitivity (e.g., chronic acid regurgitation)
- •excessive dietary or environmental exposure to acids
- •periodontal surgery in the preceding 3 months
- •orthodontic appliance treatment within previous 3 months
- •teeth or supporting structures with any other painful pathology or defects
- •teeth restored in the preceding 3 months
- •abutment teeth for fixed or removable prostheses
- •extensively restored teeth and those with restorations extending into the test area.
结局指标
主要结局
change in dentin hypersensitivity score according to Shiff's index
时间窗: 4 weeks after the baseline
Air from air/water syringe is applied perpendicular to the cervical areas of the tooth from a distance of 1 cm for a second. Enamel sensitivity is estimated in accordance with the following criteria: 0 - no reaction, 1. - discomfort but the patient does not insist on stopping the test, 2. - discomfort, accompanied by a request to discontinue the test, 3. - severe pain reaction with pronounced motor reactions aimed at the immediate termination of the test.
次要结局
未报告次要终点