Evaluating an early childhood caries prevention strategy: a study protocol for a stepped-wedge cluster randomised controlled trial
Introduction 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 implementa...
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BMJ Publishing Group
2025-08-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/8/e102143.full |
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| author | Yan Zhang Fan Zhang Wenjuan Tao Wei Yin Peiya Cao Jinming Yang Shannon H. Houser Xuedan Shi Xing Qu |
| author_facet | Yan Zhang Fan Zhang Wenjuan Tao Wei Yin Peiya Cao Jinming Yang Shannon H. Houser Xuedan Shi Xing Qu |
| author_sort | Yan Zhang |
| collection | DOAJ |
| description | Introduction 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.Methods and analysis 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.Ethics and dissemination 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.Trial registration number ChiCTR2400090741. |
| format | Article |
| id | doaj-art-28c45a2bdc5c4c8f84d6f01e95450fdf |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-08-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-28c45a2bdc5c4c8f84d6f01e95450fdf2025-08-20T02:59:39ZengBMJ Publishing GroupBMJ Open2044-60552025-08-0115810.1136/bmjopen-2025-102143Evaluating an early childhood caries prevention strategy: a study protocol for a stepped-wedge cluster randomised controlled trialYan Zhang0Fan Zhang1Wenjuan Tao2Wei Yin3Peiya Cao4Jinming Yang5Shannon H. Houser6Xuedan Shi7Xing Qu8Sichuan Provincial Maternity and Child Health Care Hospital, Chengdu, Sichuan, ChinaPhysical Examination Center, Sichuan University West China Hospital, Chengdu, Sichuan, ChinaResearch Center for Healthcare Service Management and Policy, Institute of Hospital Management, Sichuan University West China Hospital, Chengdu, Sichuan, ChinaDepartment of Preventive Dentistry, Sichuan University West China Hospital of Stomatology, Chengdu, Sichuan, ChinaResearch Center for Healthcare Service Management and Policy, Institute of Hospital Management, Sichuan University West China Hospital, Chengdu, Sichuan, ChinaWest China Biomedical Big Data Center, West China Hospital, Sichuan University, Chengdu, ChinaDepartment of Health Services Administration, The University of Alabama at Birmingham, Birmingham, Alabama, USAOutpatient department, West China Hospital, Sichuan University, Chengdu, SichuanResearch Center for Healthcare Service Management and Policy, Institute of Hospital Management, Sichuan University West China Hospital, Chengdu, Sichuan, ChinaIntroduction 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.Methods and analysis 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.Ethics and dissemination 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.Trial registration number ChiCTR2400090741.https://bmjopen.bmj.com/content/15/8/e102143.full |
| spellingShingle | Yan Zhang Fan Zhang Wenjuan Tao Wei Yin Peiya Cao Jinming Yang Shannon H. Houser Xuedan Shi Xing Qu Evaluating an early childhood caries prevention strategy: a study protocol for a stepped-wedge cluster randomised controlled trial BMJ Open |
| title | Evaluating an early childhood caries prevention strategy: a study protocol for a stepped-wedge cluster randomised controlled trial |
| title_full | Evaluating an early childhood caries prevention strategy: a study protocol for a stepped-wedge cluster randomised controlled trial |
| title_fullStr | Evaluating an early childhood caries prevention strategy: a study protocol for a stepped-wedge cluster randomised controlled trial |
| title_full_unstemmed | Evaluating an early childhood caries prevention strategy: a study protocol for a stepped-wedge cluster randomised controlled trial |
| title_short | Evaluating an early childhood caries prevention strategy: a study protocol for a stepped-wedge cluster randomised controlled trial |
| title_sort | evaluating an early childhood caries prevention strategy a study protocol for a stepped wedge cluster randomised controlled trial |
| url | https://bmjopen.bmj.com/content/15/8/e102143.full |
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