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

Mariana Pinheiro Araujo (Lead / Corresponding author), Waraf Al-Yaseen, Nicola Patricia Innes

Research output: Contribution to journalArticlepeer-review

3 Citations (Scopus)
73 Downloads (Pure)


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 many other 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 trial manager 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 factored in. Comprehensive reporting of the trial's 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.

Original languageEnglish
Pages (from-to)14-22
Number of pages9
JournalInternational Journal of Paediatric Dentistry
Issue numberS1
Early online date21 Nov 2020
Publication statusPublished - Dec 2020


  • Caries
  • Clinical ressearch
  • Clinical trials
  • Design
  • Prevention


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