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