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临床试验/NCT07091578
NCT07091578进行中(未招募)不适用

Assessing the Feasibility of School-Based Oral Health Programmes in Primary Schools in Saudi Arabia: A Pilot Study

Fatimah Alshehri1 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2024年8月18日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
202
试验地点
1
主要终点
Feasibility of implementing supervised toothbrushing and oral health education programmes based on qualitative interviews

研究概览

简要总结

The goal of this pilot study is to assess the feasibility of implementing school-based oral health programmes including supervised toothbrushing and oral health education. The main questions it aims to answer are:

  • Is it feasible to implement supervised toothbrushing and oral health education programmes in primary schools in Riyadh, Saudi Arabia?
  • What are the facilitators and barriers to implementation regarding programme acceptance, participation of school staff, and adherence to the supervision guidelines?
  • How do these programmes influence children's self-reported oral health status, risk behaviours, and quality of life during the study period?
  • What is the effect of these programmes on dental caries incidence, plaque and gingival bleeding scores over a one-year follow-up?

Participants will:

  • Take part in either a supervised toothbrushing programme or an oral health education programme.
  • Undergo dental examinations at baseline and after one year of follow-up to assess changes in dental caries, and plaque and gingival bleeding scores.

详细描述

Dental caries is one of the most widespread oral health diseases affecting populations worldwide, including Saudi Arabia. Several studies assessing dental caries prevalence in Saudi Arabia have revealed a tremendous increase in its prevalence among children over the last few decades. A systematic review examined the national prevalence of caries among Saudi schoolchildren from 1988 to 2010. The review revealed that dental caries is highly prevalent across Saudi Arabia, particularly in Riyadh City. The caries prevalence in primary teeth was approximately 80% with a mean dmft of 5.0, while in permanent teeth, the prevalence was estimated to be 70% with a mean DMF value of 3.5. A recent systematic review evaluated caries prevalence from 1999 to 2019. The results showed that the proportion level for caries among schoolchildren is high, ranging from 0.21 to 1.00 for primary teeth and from 0.05 to 0.99 for permanent teeth. This emphasises that dental caries remains a significant oral health issue in Saudi Arabia.

In Riyadh city, several studies have consistently indicated a high prevalence of dental caries and DMFT values in children. A national study explored caries prevalence and severity among schoolchildren across Saudi Arabia. This study included a nationwide sample of 19,870 school students. The study found that 65.6% of examined children had caries, with a mean dmft of 3.93 ± 3.60 and a mean DMFT of 2.42 ± 2.52. It was observed that Riyadh City exhibited the highest rate of missing teeth at 10.2%. Despite the lower prevalence of caries reported in this study compared to previous studies, it remained higher than that reported in other countries, such as the United Kingdom, with a caries prevalence of 29.3% among 5-year-old children. This illustrates that caries continues to be a significant concern and the primary oral health issue among Saudi children.

Implementation of oral health programmes in school settings is considered one of the most effective approaches for improving children's oral health, as they can reach many schoolchildren. The report titled "Oral Health Promotion: An Essential Element of a Health-Promoting School" recognised schools as an ideal environment for promoting oral health due to their significant impact on children's oral health status, knowledge, and behaviours. The report shed light on global evidence supporting the efficacy of oral health programmes in schools. It was noticed that countries adopting public health programmes, including school-based oral health programmes, have witnessed a reduction in caries prevalence.

On the other hand, the caries prevalence in Saudi Arabia remains high. Over the years, the Saudi Ministry of Health has been active in promoting oral health and has implemented a range of oral health programmes to enhance oral health, control and prevent oral diseases, including dental caries. However, no consistent national oral health school-based programmes are implemented in Saudi Arabia.

There is strong and sufficient evidence regarding the effectiveness of supervised toothbrushing with fluoride toothpaste on the oral health status of preschool and school children. A study evaluated evidence-based oral health promotion programmes. The findings indicated that supervised toothbrushing interventions have resulted in caries reductions of 40%. The author also reported that supervised toothbrushing interventions are cost-effective and more efficient when specifically targeted towards high-risk populations. The programmes that had the strongest evidence for preventing caries were implemented in Scotland, England, and Jordan. The study in Jordan, a country with a similar cultural background and social norms to Saudi Arabia. The programme lasted four years and involved daily supervised toothbrushing at school. The results showed that children in the supervised toothbrushing group exhibited better caries status and were up to 6 times less likely to have caries than the control group.

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)

盲法说明

This study adopted a single-blinded approach, with an assessor blinded to the interventions. Blinding was implemented by maintaining a clear separation of roles. The dental professionals delivering interventions were not involved in outcome assessments, and outcome assessors did not have access to information about the specific interventions received by participants. Once schools had been assigned to intervention groups, students, school staff, and the dental professionals delivering interventions were blinded due to the nature of the intervention. However, outcome assessors responsible for conducting dental examinations were blinded to participants' assigned intervention groups to minimise potential bias. Dentists acted as outcome assessors and performed baseline and follow-up dental examinations, whereas dental hygienists oversaw the interventions, including supervised toothbrushing and oral health education.

入排标准

年龄范围
5 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Students aged 5 to 8 years are in the first grade of primary school.
  • Students must be medically fit.
  • Students who provide consent to participate in the study.
  • Students for whom a parent/ legal guardian has signed the consent form.

排除标准

  • Students with systemic disease or any medically compromised condition that hinders their participation in the programme.
  • Students who refuse to provide consent to participate in the study.
  • Students for whom a parent/ legal guardian has refused to sign the consent form.

结局指标

主要结局

Feasibility of implementing supervised toothbrushing and oral health education programmes based on qualitative interviews

时间窗: At the end of the academic year (approximately 9 to 12 months after programme initiation)

Feasibility will be assessed through semi-structured interviews conducted with school staff and dental professionals. The interviews will explore programme acceptability, staff engagement, adherence to toothbrushing supervision protocols, and perceived barriers and facilitators to implementation. Data will be thematically analysed to identify factors influencing the programme implemation.

次要结局

  • Children's oral health status, behaviours, risk factors, quality of life, and socio-demographic factors using the WHO Oral Health Questionnaire for Children(Baseline and one-year follow-up)
  • Change in dental caries prevalence using dmft score(Baseline and one-year follow-up)
  • Change in plaque and gingival health using Modified Plaque and Bleeding Scores(Baseline, 9 months, and 12 months after programme initiation)

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Fatimah Alshehri

Principal Investigator

King's College London

研究点 (1)

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