Child Oral Health Pilot Programme - SmilebrightRO
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 10
- 主要终点
- Epidemiologic baseline data on caries prevalence
研究概览
简要总结
During 2019-2020, the National Oral Health Survey evaluated a significant sample of children aged 5, 6 and 12 years, gathering baseline data on oral health. Data was used to estimate the distribution and severity of dental caries, the need for community-oriented disease prevention and health promotion, and the nature of oral health intervention(s) required. The survey also established how younger age groups can be reached and evaluated. Only 14% of 6 years old children have dmft 0 and the SiC index of the same sample is 9.83. High prevalence of tooth decay with high severity scores, significant inequalities in oral health and poor use and access to services showed the need for a child oral health programme.
The originality of the project lies in the vision of using fluoridated toothpaste not only as a means of preventing new carious lesions but also in the therapeutic effect of fluoridated toothpaste, which the study set out to evaluate. This programme could represent an example of good practice for the countries in our region, starting from downstream oral health interventions, such as clinical prevention and oral health promotion, and developing towards upstream interventions.
The aim of the project is to improve oral health and reduce inequalities both in dental health and access to dental services by shifting the balance of care towards preventive care.
The programme is structured on three levels:
- Specific training for dental hygienists to deliver oral health promotion to children and nursery educators, focus on tailoring key messages outlined in the care pathway and practical preparation for delivering interventions in nurseries.
- A toothpaste/toothbrushing scheme involving free daily toothbrushing to every 3 and 4-year old child attending nursery.
- Provision of clinical prevention activities delivered by dental hygienists for children attending nurseries.
The evaluation of the programme consolidates and builds upon previous evaluation work of the National Oral Health Survey for children. Due to the fact that it is a pilot programme aiming to be further implemented at national level, an evolving model of evaluation is appropriate. This allows the evaluation to be responsive to issues emerging from its implementation and develops the programme as a result of the evaluation findings.
详细描述
Until recently, Romania has lacked baseline data regarding the oral health status of children. A previous study by Petersen et al. was conducted in the 1990s covering only five major cities and without taking into account rural areas. Some local papers described a high caries prevalence. Only one longitudinal study assesses caries trends in Romanian schoolchildren. A contemporary assessment was therefore mandatory in order to advance scientific understanding and allow for the development of adequate public health policies. During 2019-2020, the National Oral Health Survey financed by The Borrow Foundation, evaluated a significant sample of children aged 5, 6 and 12 years, gathering baseline data on oral health according to the WHO guidelines. The data was used to estimate the distribution and severity of dental caries, the need for community-oriented disease prevention and health promotion, and the nature and urgency of the oral health intervention(s) required. The survey also established how younger age groups can be reached and evaluated. Unpublished data show that only 14% of 6 years old children have dmft 0 and the SiC index of the same sample is 9.83. High prevalence of tooth decay with high severity scores, significant inequalities in oral health and poor use and access to services showed the need for a child oral health programme.
The main objectives of the program are to:
- Reorient the traditional curative approach, which is basically pathogenic, and move towards a preventive promotional approach
- Strengthen cross-sectoral collaboration across key settings, such as schools, communities and workplaces to promote habits and healthy lifestyles, integrating teachers and the family;
- Raising the priority accorded to the prevention and control of oral diseases in regional and national agendas and development goals, through strengthened cooperation and advocacy.
The programme is designed to deliver additional clinical prevention activities through dental hygienists, aimed at children aged three years and above attending priority nursery establishments in order to improve oral health of young children, and complemented the established national toothpaste/toothbrushing scheme.
The programme will be implemented for a period of 24 months, under guidance from the WHO Collaborative Centre for Epidemiology and Community Dentistry Milan, Italy. Consent from the national and regional authorities will be obtained, nurseries will be informed and the informed consent of the parents will be asked. The total sample size will be calculated according to the WHO guidelines using a stratified sampling technique for examination sites in Bucharest, Timisoara, Cluj-Napoca, Craiova, Iasi, Targu Mures and the surrounding geographical area. The programme will be conducted in collaboration with the Universities of Medicine in the capital and the cities mentioned above, under supervision of the university staff. Data collection points will be 4 kindergartens in the Capital or metropolitan areas, 2 kindergartens in each of 2 large cities, and 1 kindergarten in each 4 villages from different geographic areas.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •children aged 3-5 years attending public nurseries in Romania
排除标准
- •enamel fluorosis
- •enamel developmental defects
- •incapacity to perform tooth brushing by themselves
结局指标
主要结局
Epidemiologic baseline data on caries prevalence
时间窗: 3 months
Prevalence will be determined for the specific age group after primary examination using ICDAS criteria after calibration. Children will be examined in a seated position, using a dental mirror and a probe, without air-drying. Thus, ICDAS codes 1 and 2 will be counted together as "A". To evaluate the outcomes, a statistical analysis will be performed. All the data will be input into a spreadsheet (Microsoft Excel 2021 for Mac, version 16.4.8).The total number of existing caries will serve for the calculation of the dmft index (decayed-missing-filled teeth index) and the SiC index (Significant caries index).
Epidemiologic baseline data on caries severity
时间窗: 3 months
Clinical examinations will be performed using ICDAS criteria by calibrated medical staff from each partner university after calibration. Children will be examined in a seated position, using a dental mirror and a probe, without air-drying. Thus, ICDAS codes 1 and 2 will be counted together as "A". Statistical analysis will be performed after inputing the data into a sheet (Microsoft Excel 2021 for Mac, version 16.4.8). Severity will be determined for the specific age group after primary examination using ICDAS criteria. ICDAS codes of 0 represent sound teeth, codes of 1 and 2 represent initial reversible caries lesions, only affecting the enamel, codes of 3 represent initial microcavitation of the enamel, codes of 4 represent moderate carious lesions and codes of 5 and 6 represent extended lesions.
Epidemiologic baseline self assessment data
时间窗: 3 months
Self-assessment of oral health behaviours of children will be done using the previously designed questionnaire from the National Oral Health Survey. The working tool consists of 15 items that make up the two types of behaviour (prevention and diet), and family characteristics (parent's level of education, working status). Behaviours will be correlated with clinical indices that will help us to delimit the existence or lack of certain significant differences among children. For a better understanding of the risk factors the evaluation relates to specific elements of the child (gender, age, parental education, residence), and elements related to the objective living conditions (county development index, residence, etc.). Statistical analysis using Poisson regression will correlate data obtained from self assessment with clinical outcomes expressed by the dmft index.
Monitor caries activity
时间窗: 18 months
Follow-up data regarding changes in caries status: new lesions appearing or existing caries status changes at interim and last examination. Caries incidence rate will be calculated on each tooth as the unit of analysis and evaluated using a multi-step approach: A - The net caries increment for initial, moderate, and extensive caries severity using ICDAS (Δ-initial, Δ- moderate, and Δ- extensive) will be calculated at each follow-up examinations; B - Events will be defined as a tooth getting a lesion or as the sum of the Δ-caries changes of status recorded at the baseline examination, at interim, and at the last examination. The number of events will be appraised by subtracting the number of caries-free teeth at last examination from those at baseline. The non-parametric Mann-Whitney U test will be applied to assess the differences across mean number of events between groups.
Efficacy of the treatment
时间窗: 18 months
The efficacy of the treatment will be assessed for those who fully followed the protocol (per-protocol subjects) by calculating the reduction in risk ratio (RR) and the related number needed to treat (NNT) value. An event is defined as the change of status at tooth level, i.e. the development of a new lesion or the progression of an existing lesion to a more severe stage. Cox Proportional Hazards models will be run to assess the factors associated with caries change of status. Estimates will be reported in the hazard ratio (HR) and their respective 95% confidence interval (95%CI). For all statistical analyses, the statistical significance will be set at α=0.05
次要结局
- Daily tooth brushing pattern(12 months)
- Qualitative evaluation of the preventive activities in nurseries(12 months)
- Qualitative evaluation of oral health promotion activities(12 months)
研究者
Basaraba Gabriela Lavinia
Head of grant department
University of Medicine and Pharmacy "Victor Babes" Timisoara