Anti-gingivitis efficacy of a stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice.
OBJECTIVE
Stannous fluoride is a broad-spectrum anti-microbial agent that has been used in dentistry as a chemical adjunct to prevent dental caries and gingivitis. The objective of this study was to assess the anti-gingivitis efficacy of a stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice relative to a negative control.


METHODS
This was a randomized, 6-month, double-blind, parallel-group gingivitis study conducted according to the guidelines for evaluating chemotherapeutic products for the control of gingivitis outlined by the American Dental Association. A stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice was tested against a commercially available negative control dentifrice. Following baseline measurements, subjects received a dental prophylaxis. Subjects were then instructed to brush twice daily for 60 s using their assigned product. Oral soft-hard-tissue examinations and clinical examinations using the Modified Gingival Index, Gingival Bleeding Index, and the Turesky modification of the Quigley-Hein Plaque Index were performed at baseline, 3 and 6 months post-treatment.


RESULTS
A total of 143 subjects were enrolled and 130 of them completed the 6-month study. After 6 months of product usage, the experimental group had 21.7% less gingivitis (p<0.001), 57.1% less bleeding (p<0.001), and 6.9% less plaque (p=0.01) on average compared with the negative control group. No adverse oral soft-hard-tissue effects or extrinsic tooth staining was observed in the study.


CONCLUSIONS
The results demonstrate that use of the stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice over a 6-month period provided statistically significant reductions in gingivitis, gingival bleeding, and plaque when compared with a negative control dentifrice.
Mankodi
Suru
S
Dental Products Testing, Inc., West Palm Beach, FL, USA.
Bartizek
Robert D
RD
Winston
J Leslie
JL
Biesbrock
Aaron R
AR
McClanahan
Stephen F
SF
He
Tao
T
D000293:Adolescent; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D004311:Double-Blind Method; D005260:Female; D005891:Gingivitis / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010512:Periodontal Index; D010710:Phosphates / Q000627:therapeutic use*; D014002:Tin Fluorides / Q000627:therapeutic use*; D014100:Toothpastes / Q000627:therapeutic use*; D016896:Treatment Outcome
D010710:Phosphates; D014002:Tin Fluorides; D014100:Toothpastes; C009285:sodium polymetaphosphate