A road map for designing and reporting clinical trials in paediatric dentistry

Background Unless clinical trials are well-designed, there is a risk that they will not be usable to improve patient care. Aim This paper discusses some factors important in designing clinical trials in paediatric dentistry. It uses the prevention and management of dental caries in children as the lens through which to look at these. Findings Amongst the factors to consider are clear research questions and objectives; appropriate outcomes and outcome measures; sample size calculation and the level of randomisation; methods for random allocation; and operator/assessor training. Experts in trial design including statisticians and a trialist should be consulted early in the design process. The aspects of trial design unique to cariology trials such as 'clustering' of data items, mixed dentition issues and those related to trials involving children (communication, consent etc) should be considered. Comprehensive reporting of trial results is essential. Conclusion There are many readily available resources and tools to help the researcher design a trial of good quality that will yield results useful to the research community and beyond, to those who will implement the findings and ultimately those who will benefit from them.

Automated summary

This paper discusses important factors in designing clinical trials in pediatric dentistry, highlighting the importance of clear research questions and objectives, appropriate outcomes and outcome measures, sample size calculation and randomization levels, and operator/assessor training. Consulting experts in trial design and considering unique aspects of cariology trials are essential for a successful trial design. Comprehensive reporting of trial results is crucial for the validity and usefulness of the findings.