Item | Domain |
---|---|
1 | Abstract: structured summary of trial design, methods, results, and conclusions |
Introduction | |
2 | Scientific background and explanation of rationale with specific objectives and/or hypotheses |
Methods | |
3 | Intervention: the intervention for each group, including how and when it was administered, with sufficient detail to enable replication |
4 | Outcomes: completely defined, pre-specified primary and secondary measures of outcome, including how and when they were assessed |
5 | Sample size: how sample size was determined |
6 | Randomisation: method used to generate the random allocation sequence |
7 | Allocation: mechanism used to implement the random allocation sequence, describing any steps taken to conceal the sequence until intervention was assigned |
8 | Implementation: who generated the random allocation sequence, who enrolled teeth, and who assigned teeth to intervention |
9 | Blinding: if done, who was blinded after assignment to intervention and how |
10 | Statistics: statistical methods used to compare groups for primary and secondary outcomes |
Results | |
11 | For each primary and secondary outcome, results for each group, and the estimated size of the effect and its precision |
Discussion | |
12 | Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses |
Other information | |
13 | Sources of funding and other support role of funders |
14 | Where the full trial protocol can be accessed, if available |