A controlled 6-month clinical trial to study the effects of a stannous fluoride dentifrice on gingivitis
: Blackwell Synergy
Objectives: This study was conducted to assess anti-plaque and anti-gingivitis
benefits of a stabilized stannous fluoride (SnF2)/sodium hexametaphosphate (SHMP)
dentifrice versus a negative control.
Material and Methods: This was a randomized, 6-month, stratified, single-centre,
double-blind, parallel group, clinical study conducted in harmony with the guidelines
for evaluating chemotherapeutic products for the control of gingivitis outlined by the
American Dental Association. A stabilized 0.454% SnF2/SHMP dentifrice was tested
against a commercially available negative control dentifrice. Following baseline
measurements, subjects received a dental prophylaxis. Subjects were instructed to
brush twice daily for 60 s using their assigned product. Efficacy measurements were
obtained at baseline, 3 and 6 months post treatment using the Modified Gingival Index,
Gingival Bleeding Index and the Turesky Modified Quigley-Hein Plaque Index. Oral
tissue examinations were performed at all visits.
Results: A total of 140 subjects were enroled and 128 completed the study. Results
after 6 months showed the SnF2 dentifrice delivered a 16.9% reduction in gingivitis
(po0.001), a 40.8% reduction (po0.001) in gingival bleeding, and an 8.5% reduction
in plaque (p50.001) versus the negative control. Both treatments were well tolerated.
Conclusions: Twice daily use of the SnF2/SHMP dentifrice over 6 months provided
statistically significant anti-plaque and anti-gingivitis benefits relative to a negative
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