Cao Peiya, Zhang Yan, Houser Shannon H, Yang Jinming, Tao Wenjuan, Zhang Fan, Yin Wei, Shi Xuedan, Qu Xing
Research Center for Healthcare Service Management and Policy, Institute of Hospital Management, Sichuan University West China Hospital, Chengdu, Sichuan, China.
School of Kinesiology and Health Science, York University - Keele Campus, Toronto, Ontario, Canada.
BMJ Open. 2025 Aug 3;15(8):e102143. doi: 10.1136/bmjopen-2025-102143.
Caries risk assessment and management (CRAM) conducted by primary care providers is critical for preventing early childhood caries. Yet, the implementation of these preventive strategies remains understudied in low- and middle-income countries. This study aims to evaluate the implementation and effectiveness of a CRAM intervention in Chinese primary care settings.
We will conduct a hybrid type II stepped-wedge cluster randomised controlled trial across nine primary healthcare institutions in Luzhou City, China. Institutions will be randomly allocated into three intervention waves. Primary care providers will be trained to deliver CRAM. The two primary outcomes are (1) the proportion of primary care providers completing all CRAM procedures and (2) improvements in parents' home-based oral care practices for children under age 3. Secondary outcomes include children's oral health-related quality of life, time to first caries incidence, and the cost-effectiveness of the intervention. Qualitative interviews will explore barriers and facilitators to implementation.
The study protocol has received approval from the Ethics Committee of West China Hospital, Sichuan University. Study findings will be disseminated through peer-reviewed journal publications and presentations at academic conferences. Research summaries and policy briefs will be developed for key stakeholders and decision-makers at the local, provincial and national levels.
ChiCTR2400090741.
初级保健提供者进行的龋病风险评估与管理（CRAM）对于预防幼儿龋齿至关重要。然而，在低收入和中等收入国家，这些预防策略的实施情况仍未得到充分研究。本研究旨在评估中国初级保健机构中龋病风险评估与管理干预措施的实施情况及其效果。
我们将在中国泸州市的9家基层医疗机构开展一项II型混合阶梯式整群随机对照试验。机构将被随机分配到三个干预组。初级保健提供者将接受培训以实施龋病风险评估与管理。两个主要结局指标为：（1）完成所有龋病风险评估与管理程序的初级保健提供者的比例；（2）3岁以下儿童家长家庭口腔护理行为的改善情况。次要结局指标包括儿童口腔健康相关生活质量、首次患龋时间以及干预措施的成本效益。定性访谈将探讨实施过程中的障碍和促进因素。
本研究方案已获得四川大学华西医院伦理委员会的批准。研究结果将通过同行评审的期刊出版物以及在学术会议上的报告进行传播。将为地方、省级和国家级的关键利益相关者及决策者编写研究摘要和政策简报。
ChiCTR2400090741。
