A Randomized Clinical Trial on the Effectiveness of Oral Health Preventive Programmes in School Children in Uganda
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 610
- 试验地点
- 2
- 主要终点
- Presence of dental caries after the intervention
研究概览
简要总结
Dental caries represents a challenge for Oral Health Services in several African Countries, like Uganda. Few studies have been reported the burden of oral health, its prevention and non-operative treatment among school children in African countries.
Aim: To assess the prevalence and risk factors of dental caries and the effectiveness of strategies to prevent and treat dental caries using a non-operative approach among children in Gulu Municipality, Uganda.
Methods: The proposal RCT is structured in three phases: 1. A descriptive cross-sectional survey to collect oral data among 610 school children selected using a multistage cluster sampling; 2. A randomized unblinded two-arm trial to assess the difference in the treatment/prevention of dental caries using non-operative means among school children in the Ugandian Gulu municipality; and 3. A comparison of oral health conditions between a group of children who will be given dental cleaning tools and followed up over time versus a control group.
The oral health status of the participants will be assessed according to WHO and ICDAS guidelines. Stata 14.0. will be used for analysis; descriptive statistics will be carried out to analyze continuous and categorical variables and chi-square test as well as independent tests for bivariate analysis and modified poisson regression. In addition, the factors associated with dental caries will be determined by linear regression models using a statistical significance level of 5% (α = 0.05).
Discussion: This trial will be the first trial conducted in Uganda assessing a school-based caries prevention programme using the WHO and ICDAS standardized international guidelines. The findings obtained will increase knowledge on oral health in Uganda school children and the effectiveness of community-based caries prevention programme in this population.
详细描述
Study design
This randomized controlled clinical study will be developed in three parts: 1.) An epidemiological survey; a descriptive cross-sectional study to be conducted in Gulu Municipality to collect data on the oral health of school children to assess caries prevalence and associated factors. 2.) A field trial; an individually randomized, unblinded, two-armed trial of toothbrush/toothpaste/fluoride varnish versus education on nutrition/oral hygiene to assess the difference in treatment/prevention of dental caries. 3.) A comparison of oral health conditions among a group of children who were provided with dental cleaning tools and who were followed up and monitored over time versus a control group.
Study setting and location
The study will be conducted in Gulu Municipality, Gulu District, in Northern Uganda. The municipality has four sub-counties, each consisting of four parishes, with a total population of 177'400 according to the Uganda Bureau of Statistics (UBOS), 2020 projection [Uganda Bureau of Statistics in Uganda. April 2019 Population Projections by Subcounty and Sex (2015-2030), in Population & Censuses. 2019]. It is the largest urban center in Acholi sub-region. There are three hospitals offering oral health services in Gulu Municipality: Gulu referral hospital, St. Mary's Hospital, Lacor and Gulu independent hospital. Primary schools in Gulu Municipality will be used as study areas. The list of primary schools in the Municipality will be obtained from the District Education Officer (DEO). An ethical approval from the Ministry of Health and consents from parents of the school children will be required.
Study population
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Enrollment in one of primary schools in Gulu Municipality
- •Age between 5 and 17 years
- •Staying in the area for at least six months
- •Parent/guardian's willingness to give consent
- •Written informed consent by participant and/or parents
排除标准
- •School children who refuse to participate in the research
- •Parents who refuse their children's participation
- •Children with chronic diseases or systemic conditions that require differential care and follow-up
结局指标
主要结局
Presence of dental caries after the intervention
时间窗: 24 months
The outcome will be calculated by determining the percentage of participants diagnosed with dental caries. The mean values of carious teeth/surfaces, missing teeth/surfaces, filled teeth/surfaces and mean DMFT/S will be calculated.
Prevalence of dental caries
时间窗: 24 months
The outcome will be calculated by determining the percentage of participants diagnosed with dental caries.
Mean of dental caries
时间窗: 24 months
The mean values of carious teeth/surfaces, missing teeth/surfaces, filled teeth/surfaces and mean DMFT/S will be calculated.
次要结局
- Extent of other oral diseases(24 months)
- Cost of clinical interventions(24 months)
- Identification of dental caries symptoms(24 months)