Developing an Original Multi-Site Randomised Trial Protocol for Evaluating Community Water Fluoridation Alternatives in Nigeria

Community water fluoridation is impractical in most Nigerian settings due to infrastructure limitations, and developing an original trial protocol for evaluating cost-effective fluoride delivery alternatives provides a methodological template for advancing preventive dental policy in Nigeria. This study developed and piloted an original randomised trial protocol for evaluating school milk fluoridation and supervised brushing with fluoride toothpaste as community water fluoridation alternatives in Nigerian urban and peri-urban schools. A protocol development methodology was employed, drawing on systematic review of fluoride delivery trial methods (52 publications from 2018 to 2024), structured consultations with 18 trial design and dental public health specialists, regulatory consultation with NAFDAC and the NHREC, and a 12-month feasibility pilot in 6 schools in Ogun State. The protocol specifies a cluster-randomised three-arm design (fluoride toothpaste, school milk fluoridation, control) with 24 schools per arm, primary endpoint of 2-year DMFT increment, blinded outcome assessment, and school-level covariates in the primary analysis model. The feasibility pilot confirmed participant recruitment rate, protocol adherence, and contamination risk management. Blinding procedures, cluster allocation methods, and statistical analysis plan are detailed. Ethics considerations including parental consent processes adapted for low-literacy settings are specified. Expert review by 15 clinical trial and preventive dentistry specialists confirmed the protocol's methodological rigour. Recommendations include funding from TETFUND for full-scale implementation across three geopolitical zones.

Keywords: community fluoridation alternatives, randomised trial protocol, fluoride toothpaste, school milk fluoridation, Nigeria