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. 2018 Dec 18;2018(12):CD006202. doi: 10.1002/14651858.CD006202.pub2

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:
  • subjects had to present with 8 incisors without any fillings, crowns, or fixed orthodontic appliances


Exclusion criteria:
  • exhibit no oral or facial pain or disease

  • more than 3 cups of tea and/or coffee


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