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

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
Participants Participants: 18 to 54 years old. Mean age 28.9 years
Total number: 111
Inclusion criteria:
  • presence of all anterior teeth

  • no more than 3 restorations

  • no orthodontic treatment

  • Lobene stain index between 0.33 and 1.5


Exclusion criteria:
  • diabetes or systemic disease

  • oral and facial pain

  • sensitivity to polyphosphate‐containing dentifrices


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
Interventions Total number of intervention groups: 2
Experimental: sodium tripolyphosphate (1%) containing gum
Control: placebo
Duration of treatment: 6 weeks
Outcomes Reduction in stain intensity and extent of stain
Lobene modified index: smaller value shows improvement
Stain composite index: smaller value shows improvement
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
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