The Effect of a Dentist Administered Cognitive Behavioural Therapy (D-CBT) in Adult Patients With Dental Fear
试验速览
- 阶段
- 不适用
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Level of Dental anxiety, Dental Anxiety Scale ( MDAS)
研究概览
简要总结
The study is an RCT study comparing a 3-5 intervention treatment with dentist administered Cognitive Behavioural Therapy ( D-CBT) with a control treatment. The control treatment is a "treatment as usual" concept using premedication with benzodiazepines and a common sense approach.
The treatment will be performed in a regular dental office. The dentist is working as a regular dentist and is trained in the CBT Method.
详细描述
Brief Summary:
The study is an randomized clinical trial (RCT) comparing a 3-5 intervention treatment with dentist administered Cognitive Behavioural Therapy ( D-CBT) with a control treatment. The control treatment is a "treatment as usual" concept using premedication with benzodiazepines and a common sense approach.
The treatment will be performed in a regular dental office. The dentist is working as a regular dentist and is trained in the CBT Method.
Detailed Description:
Background Dental fear is common in adults and has a prevalence of about 10-25%. Approximately 2/3 of fearful patients manage to get through treatment, but with great discomfort. The remaining 1/3 avoid dental visits and some of them qualify for the diagnosis odontophobia (prevalence 1,4-7,1%).
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
- Single (Outcomes Assessor)
盲法说明
Each patient receives a project number. A codebook between project number and journal number is stored at Tannhelsetjenestens kompetansesenter sør in Arendal. All data will be registered online using Nettskjema to collect data directly into Services for sensitive data (TSD). The research data from each patient will only be identified by the project number.
All data will be stored and analysed using the TSD platform. TSD complies with the directive of privacy and electronic communication in Norway. TSD is developed and operated by USIT, the UiO centre for IT.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Strong dental anxiety that affects the patients self-perceived ability to go through dental treatment
- •Age over 18
- •Agreement to all the practical arrangements of the study
排除标准
- •Substance abuse
- •Not being able to communicate fluently in Norwegian
结局指标
主要结局
Level of Dental anxiety, Dental Anxiety Scale ( MDAS)
时间窗: At baseline, after 3-5 weeks of treatment, after 1 year and after 5 years
MDAS is a 5 item scale measuring dental anxiety in a range from 5-25. Outcome measure: change in MDAS
次要结局
未报告次要终点
研究者
Tiril Willumsen
Professor
University of Oslo