Excavation of Root Caries with Air-water Powder Stream Vs Manual Excavation for Atraumatic Restorative Treatment in Older Patients: a Single-blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Restoration Success rate
研究概览
简要总结
The main objective of this RCT is to compare the efficacy of a powder/water jet prophylaxis device and conventional hand excavation in excavating root surface caries, with regard to restoration survival/success in older adults.
The secondary outcome of this RCT is to assess the participants' treatment preferences for the received treatment with regard to the procedures involved and in the invasiveness of the procedures carried out during the ART restoration.
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 (Participant)
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
- •Adults ≥65 years
- •Dentinal root caries lesions with no painful symptomology
- •Can follow instructions for oral hygiene
- •Not dependent for care for their ADLs.
排除标准
- •Symptomatic carious teeth
- •Non-carious attrition, erosion or abrasion cavities
- •Periodontally compromised teeth with Grade 3 mobility, and active signs of infections.
- •Not willing or able to sign informed consent
- •Post-hoc exclusion:
- •Participant withdraws consent
- •Medical reasons.
研究组 & 干预措施
Control: Hand instrumentation for caries excavation
Hand instrumentation for caries excavation
干预措施: Control: Hand instrumentation for caries excavation (Procedure)
Intervention 1: EMS Airflow device for caries excavation
Powder/water jet prophylaxis device (EMS Airflow) for caries excavation
干预措施: Intervention 1: EMS Airflow device for caries excavation (Procedure)
Intervention 2: Hand excavation + EMS Airflow device for caries excavation
Hand excavation and Powder/ jet prophylaxis device (EMS Airflow) for caries excavation
干预措施: Intervention 2: Hand excavation + EMS Airflow device for caries excavation (Procedure)
结局指标
主要结局
Restoration Success rate
时间窗: 1 year, year 1
Restoration success rate (SxR %): For the purpose of this trial, a successful restoration is defined as one that has undergone no changes in its surface / structural integrity, still adhered to the structure and is functional when examined during the scheduled or unscheduled recall visit. The restoration success rate (SxR %) is calculated by the number of successful restorations present at the end of the trial (nsx) divided by the number of restorations placed in the beginning of the trial (N0) multiplied by 100 using the formula: SxR % = (nsx / N0) \* 100.
Restoration survival rate
时间窗: 1 year, year 1
Restoration survival rate (SvR %): For the purpose of this trial, any restoration, where the surface or structural integrity is compromised, but still adhering to the tooth, is functional and does not warrant a repair or replacement when examined during the scheduled or unscheduled recall visit, is considered survived. The restoration survival rate (SvR %) is calculated by the number of survived restorations present at the end of the trial (nsv) divided by the number of restorations placed in the beginning of the trial (N0) multiplied by 100 using the formula: SvR = (nsv / N0) \* 100.
次要结局
- Participants' Treatment preference(Through study completion, an average of 1 year)
研究者
Murali Srinivasan, Dr. med. dent., BDS, MDS, MBA, MAS
Prof.
University of Zurich