Porciani 2010.
Methods | Title: effect on dental stain occurrence by chewing gum containing sodium tripolyphosphate Trial design: double‐blinded, parallel‐group, randomised controlled trial Location: not reported Language: English Number of centres: 1 Recruitment period: not reported Funding source: Perfetti van Melle |
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Participants | Participants: 18 to 54 years old. Mean age 28.9 years Total number: 111 Inclusion criteria:
Exclusion criteria:
Number randomised: 111 Method of randomisation: random table Method of allocation concealment: not reported Method of blinding: similar looking package, shape, flavour and weight of the chewing gum. Participants instructed not to discuss the treatment they were receiving Number evaluated: 108. 3 participants dropped out from experiment group |
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Interventions | Total number of intervention groups: 2 Experimental: sodium tripolyphosphate (1%) containing gum Control: placebo Duration of treatment: 6 weeks |
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Outcomes | Reduction in stain intensity and extent of stain Lobene modified index: smaller value shows improvement Stain composite index: smaller value shows improvement |
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Notes | Sample size calculation: not reported Adverse effects: not reported Health‐related quality of life: not reported Key conclusions of the study authors: "This trial showed a reduction in dental stain by a chewing gum containing sodium tripolyphosphate after 6 weeks" Contact: PF Porciani, piercateadsl@libero.it |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Each subject entered in the test or control group using a random table .." |
Allocation concealment (selection bias) | Unclear risk | Not mentioned |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Both chewing gums had the same flavour, weight, shape, colour, and packaging so that the participants were blinded as to the identity of the gum" Comment: additionally, participants were instructed not to tell other subjects to which group they were assigned in order to minimize inadvertent disclosure to the study participants and staff |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Data were scored by the same blinded operator for all measurements" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "... 3 eventually dropped out, though the cause was unrelated to polyphosphates" Comment: plausible effect size (difference in means ) among missing outcomes not enough to have a clinically relevant impact on observed effect size |
Selective reporting (reporting bias) | Low risk | All outcomes mentioned were reported adequately. Conclusion reflected study results (in the abstract) |
Other bias | Low risk | None |