A Comparative Study of a Self-adhering Material in Dental Hypersensitivity in Xerostomic Patients Due to Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Evaluation of change of dentinal hypersensitivity after treatment
研究概览
简要总结
Aim: To compare the desensitizing capacity of Vertise Flow™ (VF), a new self adhering material, in the treatment of dentine hypersensitivity (DH) in patients who are xerostomic due to radiotherapy for head and neck cancer.
Methods: A total of 17 patients were selected for the study. The study was conducted as a split-mouth randomized clinical trial comparing: 1) VF 2) Universal Dentin Sealant (UDS), 3) Clearfil Protect Bond (CPB) and 4) Flor-Opal® Varnish (FOV). Basal and stimulated salivary flow was recorded for each patient according to the method described by Sreebny. The pain experience was generated by a cold stimulus directly to a sensitive tooth surface and assessed using the Visual Analogue Scale (VAS). The response was recorded before the application of the materials (PRE-1), immediately after (POST-1), at 1-week (POST-2), 4-weeks (POST-3) and 12-week controls (POST-4).
详细描述
Participants The study was designed as a split-mouth randomized clinical trial. The protocol and informed consent forms were approved by the ethics committee at the University of Sassari (n° 1000/CE).
To participate in the study, all the subjects were carefully informed about the study's purpose, risks and benefits.
The study inclusion criteria were the following:
- Generally good health despite the seriousness of their illness;
- A clinical reduction of salivary flow;
- The presence of two or three teeth which were hypersensitive to stimulation with a blast of air.
In addition, patients were considered suitable for the study if they had sensitive teeth showing abrasion, erosion or recession with the exposure of the cervical dentine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Generally good health despite the seriousness of their illness;
- •A clinical reduction of salivary flow;
- •The presence of two or three teeth which were hypersensitive to stimulation with a blast of air.
- •In addition, patients were considered suitable for the study if they had sensitive teeth showing abrasion, erosion or recession with the exposure of the cervical dentine.
排除标准
- •teeth with subjective or objective evidence of carious lesions, pulpitis, restorations, premature contact, cracked enamel, active periapical infection or that had received periodontal surgery or root-planning up to 6 months prior to the investigation;
- •patients who had received professional desensitizing therapy during the previous 3 months;
- •patients who had used desensitizing toothpaste in the last 6 weeks. Patients were also excluded if they were under significant medication that could have interfered with pain perception (e.g., antidepressants, anti-inflammatory drugs, sedatives, and muscle relaxants).
结局指标
主要结局
Evaluation of change of dentinal hypersensitivity after treatment
时间窗: before the treatment (PRE-1), immediately after (POST-1), after 1 week (POST-2), 4 weeks (POST-3), and 12 weeks (POST-4).
The pain experience was assessed by a Visual Analogue Scale (VAS) using the methodology. The VAS scale consisted of a horizontal line that was 100 mm long, on which 'no pain' was marked on the right-hand extremity and 'unbearable pain' on the other. The patients expressed the intensity of the pain experienced by placing a mark at any point along the continuum. The distance, expressed in millimetres, from the right edge of 'no pain' was used as the VAS score. Each patient was asked to rate the perception of discomfort after the application of air via a dental syringe at 45-60 psi, 1 cm at the cervical third of the tooth after removing supragingival plaque with a low- speed handpiece with pumice powder and without fluoride. The adjacent teeth were covered by cotton rolls. The stimulus was delivered until reaction or up to a maximum duration of 10 s by the same examiner with the same equipment yielding similar air pressure each time.
次要结局
未报告次要终点
研究者
Egle Milia
Prof
Università degli Studi di Sassari