Control of Pain Due to Dentin Hypersensitivity in Individuals With Molar-incisor Hypomineralization: Study Protocol for a Randomized, Controlled, Clinical Trial
试验速览
- 阶段
- 1 期
- 入组人数
- 140
- 主要终点
- Change in pain evaluated through a Visual Analog Scale (VAS)
研究概览
简要总结
Background: Dentin hypersensitivity (DH) is defined as high sensitivity of the vital dentin when exposed to thermal, chemical or tactile stimuli. Two mechanisms are required for the occurrence of DH: 1) the dentin must be exposed and 2) the dentinal tubules must be open and connected to the pulp. Molar-incisor hypomineralization (MIH) is a qualitative abnormality of a genetic origin that affects tooth enamel and, in most cases, is accompanied by DH. The control of tooth sensitivity is fundamental to the successful treatment of MIH.
Objective: The aim of the proposed randomized, controlled, clinical trial is to evaluate the effectiveness of different protocols for the control of DH in patients with teeth affected by MIH.
Methods: One hundred forty patients who meet the inclusion criteria will be allocated to four groups. Group 1 will be the control group (placebo). In Group 2, sensitive teeth will be sealed with Permaseal (Ultradent). In Group 3, sensitive teeth will receive low-level laser (LLL) (AsGaAl) at a wavelength of 780 nm (Laser XT Therapy, DMC, São Carlos, SP, Brazil). In Group 4, sensitive teeth will be treated with both LLL and Permaseal (Ultradent). DH will be evaluated 15 min after the application of the treatments and the patients will be reevaluated one week, one month, three months and six months after the treatments.
Discussion: This study will enable the determination of differences in the effectiveness of the proposed treatments as well as differences among the evaluation times for each proposed treatment.
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, Outcomes Assessor)
盲法说明
All volunteers and the evaluator of the degree of sensitivity will be blinded to the allocation. The researcher in charge of applying the products will not be blinded due to the different forms of clinical manipulation of the products.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 35 years;
- •Good overall health;
- •At least one tooth with MIH and DH reported in the cervical region with sensitivity equal to or greater than 4 on the VAS.
排除标准
- •Active caries or defective restorations on the tooth to be analyzed;
- •Sufficient dentin loss that requires restorative treatment or periodontal surgery;
- •Having undergone any professional desensitizing treatment in the previous six months;
- •Having used a desensitizing paste in the previous three months;
- •Use of anti-inflammatory drugs or analgesics at the time of recruitment;
- •Currently pregnant or nursing.
结局指标
主要结局
Change in pain evaluated through a Visual Analog Scale (VAS)
时间窗: Baseline, one week, one month, three months and six months after the final treatment session.
The researcher will assess the sensitive tooth using cold air from the triple syringe (2 s of compressed air at a pressure of approximately 40 psi with the syringe perpendicular to the tooth surface at a distance of approximately 0.5 cm). Neighboring teeth will be protected with cotton rolls or the examiner's fingers9. The volunteer will then indicate a whole number between 0 (absence of pain) to 10 (worst pain possible) on the 10-cm VAS scale that best describes his/her perception of pain.
次要结局
未报告次要终点
研究者
Sandra Kalil Bussadori
Principal Investigator
University of Nove de Julho