Survival Rate and Cost-effectiveness of Glass Ionomer Restorations in the Primary Molars Using ART and Conventional Cavity Preparations in South African Children: a Randomized Controlled Non Inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Survival rate of posterior occlusal multi-surface restorations
研究概览
简要总结
This study will investigate the performance and cost-effectiveness of glass-ionomer restorations placed in school children in an outreach setting in rural areas in South Africa over a 2-year period, when placed using either ART (in a classroom) or conventional (in a mobile clinic) cavity preparation.
详细描述
Access to dental care in South African townships is very limited, as indicated by a caries prevalence of 84% and severity of 4.9 (dmft) in 6 year olds. To tackle this burden school-based tooth-brushing programs have been suggested to be cost-effective while reducing inequalities in accessibility. However, despite their efforts, the caries burden remains high.
Alternatives are mobile dental services or treatment techniques that do not require extensive equipment such as Atraumatic Restorative Treatment (ART). Mobile dental services are more cost-effective than stationary clinics, but the costs of acquiring, outfitting, and running a mobile dental truck are factors that may hamper the broader use of this model. ART on the other hand is easy to execute with minimal equipment and monetary resources. But the drawback is a typically lower survival rate of ART restorations compared to conventional placed restorations.
This study aims to further assess and compare the performance and cost-effectiveness of glass-ionomer restorations when placed using either ART (in a classroom) or conventional (in a mobile clinic) cavity preparation in South African school children stemming from a periurban area. The results of this research may help to assess and implement future oral health care programs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General Inclusion Criteria:
- •Children (4-8 years of age)
- •Guardians have given informed consent
- •Child is cooperative and assented
- •Inclusion criteria for teeth
- •Cavity > 1 mm
- •Tooth has no pathological mobility
- •Tooth has no preexisting developmental defects
- •Tooth has no pulp exposure or is indication for endodontic treatment
- •No pain, fistula or abscess related to the selected tooth
排除标准
- •Cavity > 1 mm
- •Tooth has no pathological mobility
研究组 & 干预措施
Atraumatic Restorative Treatment (ART)
GIC restorations placed using ART in a class room.
干预措施: Atraumatic Restorative Treatment (ART) (Procedure)
Conventional Cavity Preparation
GIC restorations placed using conventional cavity preparation in a mobile clinic.
干预措施: Conventional Cavity Preparation (Procedure)
结局指标
主要结局
Survival rate of posterior occlusal multi-surface restorations
时间窗: 24 months
Restorations are assessed using the ART criteria by Frencken: Survival: Code 0 (Present, satisfactory); Code 1 (Present, slight deficiency at cavity margin of less than 0.5 mm) Failure: Code 2 (Present, deficiency at cavity margin of 0.5 mm or more); Code 3 (Present, fracture in restoration); Code 4 (Present, fracture in tooth); Code 5 (Present, overextension of approximal margin of 0.5 mm or more); Code 6 (Not present, most or all of restoration missing); Code 7 (Not present, other restorative treatment performed); Code C (Dentin carious lesion present)
次要结局
- Survival rate of restorations depending on lesion type (occlusal single surface, occlusal multi surface and approximal restorations)(6, 12 and 24 months)
- Incremental cost-effectiveness ratio (ICER)(6, 12 and 24 months)