Biesbrock 2004.
Methods | Title: a chewing gum containing 7.5% sodium hexametaphosphate inhibits stain deposition compared with a placebo chewing gum Trial design: cross‐over randomised controlled trial Location: USA Language: English Number of centres: 1 Recruitment period: not reported Funding source: Procter & Gamble |
|
Participants | Participants: 18 to 70 years old. Mean age: 39.1 years Total number: 20 Inclusion criteria:
Exclusion criteria:
Number randomised: 19 Method of randomisation: not reported Method of allocation concealment: not reported Method of blinding: not reported Number evaluated: 18 |
|
Interventions | Total number of intervention groups: 2 (cross‐over) 7.5% sodium hexametaphosphate chewing gum Placebo Duration of treatment: 2 weeks with 78 hours washout time |
|
Outcomes | Improvement in tooth shade: reduction in stain ΔL, a*, b* values were recorded. Increase in L and reduction in b indicated whitening |
|
Notes | Sample size calculation: not reported Adverse effects: not reported Health‐related quality of life: not reported Key conclusions of the study authors: "Sodium hexametaphosphate delivered from a chewing gum prevents dental stain formation and facilitates stain removal, which leads to a perceptible whitening benefit" Correspondence required: no Contact: Dr Aron RB, Procter and Gamble Company, Healthcare Research Center, Manson, Ohio, USA |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Subjects were randomly assigned to one of two treatment groups." However, method was not reported |
Allocation concealment (selection bias) | Unclear risk | Not mentioned |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "Randomised, double‐blinded cross‐over trial." However, method was not reported |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "Randomised, double‐blinded cross‐over trial." However, method was not reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "1 woman abandoned the study" 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 described were reported. Conclusions are in accordance with the results |
Other bias | Low risk | None |