Randomised Controlled Clinical Trial to Compare Restorative Materials in the Treatment of Root Caries in an Older Irish Population.
试验速览
- 阶段
- 不适用
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Survival of restorations
研究概览
简要总结
This study will involve filling teeth which have decay on their roots with three different filling materials. Patients will attend Cork University Dental School and hospital for a clinical examination and to complete a questionnaire describing how they feel about the comfort and appearance of their teeth. Patients will be asked to provide a sample of saliva by spitting into a tube. This saliva will be tested to see what levels of bacteria are present and how well their saliva neutralises acid in their diet. This is used to assess how high or low the patient's risk of dental decay is. They will also complete a questionnaire about the amount of sugar in their diet and how often they clean their teeth. If the exam shows that any teeth are so decayed that they cannot be filled, the patient will then be offered extraction of these teeth. All treatment will be discussed with the patient. Patients will be randomly assigned one of the three materials and this material will be used for their fillings. Patients will not know which of the three materials they received but all three materials are already in use in dentistry and all of the elements of each treatment plan are well recognised, routine dental procedures. After all the treatment has been completed, each patient will be shown how best to take care of their teeth and how to manage their sugar intake to reduce their risk of further decay.
Patients will be given appointments to return for review at 6 months, 12 months, 18 months and 24 months after treatment. This will include a dental examination and dental impressions will be taken. These are used to measure how the restorative materials wear over time. Patients will also be asked to complete again the two questionnaires that they completed at their first visit to see if any of their answers have changed.
详细描述
Randomized Clinical Trial This study is a prospective study of older adults. It will assess the suitability of BiodentineTM as a filling material for Class V lesions and compare it's performance to that of Glass ionomer cement (GIC) and Resin-modified glass ionomer cement (RMGIC).
Patients for the study will attend Cork University Dental School and Hospital. These patients will represent a sample of the population of elderly who are generally well and able to care for themselves independently as well as adhere to a given maintenance programme. The general methods are outlined below.
Ethical Approval Ethical approval has been obtained from the Research Ethics Committee of the Cork Teaching Hospitals (CREC) for the recruitment, sampling, and treatment of elderly patients. Written informed consent will be obtained from all participants.
Inclusion Criteria
For inclusion in this research patients will:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 2 natural teeth with active root caries
- •Aged 65 or older
排除标准
- •Unable to give consent
- •Edentulous
- •No active carious root surfaces
结局指标
主要结局
Survival of restorations
时间窗: 2 year follow up
Restorations will be assessed by a blinded examiner to determine whether they are still in situ or whether they have been lost.
次要结局
未报告次要终点
研究者
Martina Hayes
Clinical Research Fellow in Restorative Dentistry
University College Cork
