Porciani 2006.
Methods | Title: whitening effect by stain inhibition from a chewing gum with sodium hexametaphosphate in a controlled 12‐week single‐blinded trial Trial design: randomised, single‐blinded, cross‐over trial Location: University of Siena, Dental School, Siena, Italy Language: English Number of centres: 1 Recruitment period: not reported Funding source: Perfetti Van Melle |
|
Participants | Participants: mean age 30.6 years Total number: 54 Inclusion criteria:
Exclusion criteria:
Number randomised: 54 Method of randomisation: not reported Method of allocation concealment: not reported Method of blinding: not reported Number evaluated: 54 |
|
Interventions | Total number of intervention groups: 2 4% sodium hexametaphosphate Placebo Duration of treatment: 12 weeks |
|
Outcomes | Reduction in stain (0 = no stain, 1 = light stain, 2 = moderate stain, 3 = heavy stain) Stain area (0 = no stain, 1 = stain covering up to 1/3 of the region, 2 = stain covering from 1/3 to 2/3 of the region, and 3 = stain covering greater than 2/3 of the region) Stain intensity Smoker versus non‐smokers |
|
Notes | Sample size calculation: not reported Adverse effects: not reported Health‐related quality of life: not reported Key conclusions of the study authors: "The results indicated that chewing gum containing sodium hexametaphosphate reduced induced stain formation by 33% compared to no gum treatment" Correspondence required: no Contact: Francesco Porciani, piercateadsl@libero.it |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "were randomly assigned to the test gum or no‐gum group.." However, method of randomisation is not reported |
Allocation concealment (selection bias) | Unclear risk | Not mentioned |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not mentioned |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "the teeth were scored for stain deposits by the same examiner who was blinded to the product assignments" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "All 54 subjects (27 females and 27 males) initially enrolled in the study completed it" |
Selective reporting (reporting bias) | Low risk | All outcomes described were reported. Conclusions are in accordance with the results |
Other bias | Low risk | None |