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