Effectiveness of a Bonding and a Fluoride Varnish for Long-term Dentin Hypersensitivity Treatment: a Split-mouth Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Level of Pain assessment with the Schiff Sensitivity Scale
研究概览
简要总结
Objectives:
The aim of this in vivo randomized clinical trial with split-mouth design was to evaluate the clinical efficacy of one in-office application of a fluoride containing varnish and in office application of a bonding resin in adult patients presenting with dentin hypersensitivity.
Materials and Methods:
The study cohort consisted of 38 Caucasian outpatients, giving a total of 180 teeth were treated by fluoride varnish (FV) and 160 - by bonding agent (BA). Baseline pain in FV group was slightly higher on both scales (SCHIFF and VAS). Outcome measurements were assessed one or two weeks before product application (enrollment), at baseline at the application days (end of the run-in period: T0a, T0b, T0c), and at 1 week and at 1-2-6 months after first 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)
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
- •absence of systemic pathologies (ASA class I);
- •not pregnant or lactating;
- •good oral hygiene;
- •with ≥1 sensitive tooth with exposed dentin on upper or lower dental arches;
- •contemporary presence of exposed dentin both on the left and right counterpart of upper or lower arch.
排除标准
- •domestic or in-office professional fluoride application and bleaching 6 months before beginning of treatment;
- •long-term use of anti-inflammatory, analgesic and psychotropic drugs;
- •eating disorders, systemic conditions that cause or predispose patients to develop dentin hypersensitivity (for example, Gastroesophageal reflux disease);
- •periodontal surgery and within the previous three months before the study;
- •orthodontic treatment within the previous three months before the study.
结局指标
主要结局
Level of Pain assessment with the Schiff Sensitivity Scale
时间窗: All study participants were asked to record the pain intensity score at six months after the application of the desensitizing agents
A score of 0, 1, 2 or 3 was given by the participant. 0 = No subject response to stimulus, 1 = Subject response but will continue, 2 = Subject responds and moves or requests discontinuation, 3 = Painful response to stimulus, discontinuation requested. The lower the score, the lower the hypersensitivity. Air-blast stimulus was used: the response to a jet of cold air was rated by the examiner.
次要结局
- Level of Pain assessment with the Visual Analogue Scale (VAS)(All study participants were asked to record the pain intensity score at six months after the application of the desensitizing agents)
研究者
Livia Ottolenghi
DDS, PhD, Full Professor, Deputy Dean of the Faculty of Medicine and Dentistry, Dean of the Dental School
University of Roma La Sapienza