Long-term Response of Three Biomaterials Used as Desensitizer Agents Under Oral Environmental Exposure.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Evaluation of change of dentinal hypersensitivity after treatment
研究概览
简要总结
Aim: to investigate the clinical effectiveness over 12 weeks of three different biomaterials, nano-hydroxyapatite based, in the therapy of the dental sensitivity.
Methods: The study is designed as a randomized clinical trial comparing: 1) Cavex Bite&White ExSense, 2) Teethmate™ Desensitizer , 3) Ghimas Dentin Desensitizer. 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 is designed as randomized clinical trial. The participants will be selected from the regular attenders of the Dental Clinic in the University of Sassari, Italy.
Inclusion criteria:
• patients will be considered suitable for the study if they have sensitive teeth showing abrasion, erosion, or recession with the exposure of the cervical dentine;
Exclusion criteria:
- teeth with subjective or objective evidence of carious lesions, pulpitis, restorations, premature contact, cracked enamel, active periapical infection, or which had received periodontal surgery or root-planning up to 6 months prior to the investigation will be excluded from the study
- professional desensitizing therapy during the previous 3 months, or use of desensitizing toothpaste in the last 6 weeks.
- Patients will be also excluded if they will be under significant medication that could interfere with pain perception (e.g., antidepressants, anti-inflammatory drugs, sedatives, and muscle relaxants).
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
- •patients will be 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 which had received periodontal surgery or root-planning up to 6 months prior to the investigation will be excluded from the study
- •professional desensitizing therapy during the previous 3 months, or use of desensitizing toothpaste in the last 6 weeks.
- •Patients will be also excluded if they will be under significant medication that could interfere with pain perception (e.g., antidepressants, anti-inflammatory drugs, sedatives, and muscle relaxants).
研究组 & 干预措施
Patients with dentin hypersensitivity
Patients with evident clinical signs of dentin hypersensitivity The following dental materials will be used following the manufacturers' instructions: Cavex Bite&White ExSense; Kuraray Teethmate™ Desensitizer; Ghimas Dentin Desensitizer.
In view of the treatment with the desensitizing agents, teeth were randomly assigned into four groups.
The application of the materials will be made only once. The effectiveness will be evaluated: immediately after application and after 1, 4, 12 weeks.
干预措施: Cavex Bite&White ExSense (Other)
Patients with dentin hypersensitivity
Patients with evident clinical signs of dentin hypersensitivity The following dental materials will be used following the manufacturers' instructions: Cavex Bite&White ExSense; Kuraray Teethmate™ Desensitizer; Ghimas Dentin Desensitizer.
In view of the treatment with the desensitizing agents, teeth were randomly assigned into four groups.
The application of the materials will be made only once. The effectiveness will be evaluated: immediately after application and after 1, 4, 12 weeks.
干预措施: Kuraray Teethmate™ Desensitizer (Other)
Patients with dentin hypersensitivity
Patients with evident clinical signs of dentin hypersensitivity The following dental materials will be used following the manufacturers' instructions: Cavex Bite&White ExSense; Kuraray Teethmate™ Desensitizer; Ghimas Dentin Desensitizer.
In view of the treatment with the desensitizing agents, teeth were randomly assigned into four groups.
The application of the materials will be made only once. The effectiveness will be evaluated: immediately after application and after 1, 4, 12 weeks.
干预措施: Ghimas Dentin Desensitizer (Other)
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