Randomized clinical trial assessing anti-gingivitis efficacy of two stannous fluoride dentifrices and zinc/arginine dentifrice.
Level 2 - randomized trial
Individual randomized controlled trial with blinded evaluation
What was done
A single-center, randomized, double-blind, 4-treatment, parallel-group, 3-month clinical trial evaluated 161 healthy adults with gingivitis (mean age 38.8 years). Subjects brushed twice daily for 1 minute with a manual toothbrush and one of four dentifrices: SnF2 dentifrice A (stannous fluoride 1,100 ppm F + sodium fluoride 350 ppm F + sodium hexametaphosphate), SnF2 dentifrice B (stannous fluoride 1,100 ppm F + sodium fluoride 350 ppm F + citrate), Zn/Arg dentifrice (zinc/arginine + sodium fluoride 1,450 ppm F), or a negative control dentifrice (sodium monofluorophosphate 1,000 ppm F + sodium fluoride 450 ppm F). Gingival bleeding sites were assessed using the Gingival Bleeding Index at Baseline, Week 2, Week 4, and Week 12. Plaque was assessed at Baseline and Week 12 using the Turesky Modified Quigley-Hein Index.
What was found
Baseline bleeding sites averaged 78.74 (SD 31.16) across groups (P = 0.537). Of 161 randomized subjects, 154 completed the study and 153 had evaluable data at Week 12. - SnF2 dentifrice A significantly reduced bleeding sites versus negative control at Weeks 2, 4, and 12 by 15.4%, 13.7%, and 17.2%, respectively. - SnF2 dentifrice B significantly reduced bleeding sites versus negative control at Week 4 by 13.9% (P = 0.041). - Relative to Zn/Arg dentifrice, SnF2 dentifrice A reduced bleeding sites by 23.4%, 17.2%, and 20.9% at Weeks 2, 4, and 12, respectively (P <= 0.007). - Relative to Zn/Arg dentifrice, SnF2 dentifrice B reduced bleeding sites by 17.4% and 14.4% at Weeks 4 and 12, respectively (P <= 0.035). - Zn/Arg dentifrice did not significantly differ from negative control for bleeding sites (P >= 0.127) or plaque (P = 0.175). - Both SnF2 dentifrices significantly reduced Week 12 plaque versus negative control and Zn/Arg (P <= 0.029). All dentifrices were reported as well tolerated.
Why it matters
The study shows that bioavailable stannous fluoride dentifrices provide superior gingival bleeding reduction and plaque control compared to a zinc/arginine formulation and conventional fluoride toothpaste.
Limits
The trial was conducted at a single center over 12 weeks, limiting assessment of longer-term efficacy and potential side effects such as extrinsic tooth staining. Numerical plaque scores, confidence intervals, and detailed adverse event counts were not reported in the abstract.
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