The comparative efficacy of stabilized stannous fluoride/sodium hexametaphosphate dentifrice and sodium fluoride/triclosan/copolymer dentifrice for the control of gingivitis: a 6-month randomized clinical study.
BACKGROUND
Antimicrobial agents such as stannous fluoride and triclosan have been incorporated into dentifrice formulations and have been shown to be effective in reducing gingivitis. The objective of this study was to compare the anti-gingivitis efficacy of a 0.454% stannous fluoride/sodium hexametaphosphate dentifrice to a positive control triclosan/copolymer dentifrice.


METHODS
This was a 6-month, randomized, double-masked, parallel-group study conducted according to the American Dental Association guidelines for evaluating chemotherapeutic products for the control of gingivitis. A 0.454% stannous fluoride/sodium hexametaphosphate dentifrice was tested against a commercially available positive control dentifrice (0.30% triclosan/2.0% Gantrez copolymer). Following baseline measurements, subjects received a dental prophylaxis. Subjects were then instructed to brush twice daily for 60 seconds using their assigned product. Tooth brushing was supervised for 3 days of each week. Clinical examinations using a gingival index were performed at baseline and at 3 and 6 months.


RESULTS
A total of 199 subjects were enrolled and 186 completed the 6-month study. Average baseline gingivitis and bleeding scores were similar for the two treatment groups. After 6 months, the experimental group had statistically significantly less gingivitis (25.8%) and statistically significantly less bleeding (27.4%) on average compared to the control group. Neither adverse oral soft tissue effects nor tooth staining were reported.


CONCLUSIONS
Within the limits of the study protocol, the results demonstrated superior therapeutic benefits for the stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice in reducing gingivitis compared to the triclosan/copolymer control in this partially supervised study.
Archila
Luis
L
Department of Dental Diagnostic Science, The University of Texas Health Science Center at San Antonio Dental School, San Antonio, TX, 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; D000891:Anti-Infective Agents, Local / Q000627:therapeutic use; D003802:Dentifrices / Q000737:chemistry / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005891:Gingivitis / Q000517:prevention & control*; D006801:Humans; D008297:Male; D008298:Maleates / Q000627:therapeutic use; D008875:Middle Aged; D010512:Periodontal Index; D010710:Phosphates / Q000627:therapeutic use*; D011145:Polyvinyls / Q000627:therapeutic use; D012969:Sodium Fluoride / Q000627:therapeutic use; D014002:Tin Fluorides / Q000627:therapeutic use*; D014260:Triclosan / Q000627:therapeutic use
D000891:Anti-Infective Agents, Local; D003802:Dentifrices; D004338:Drug Combinations; D008298:Maleates; D010710:Phosphates; D011145:Polyvinyls; D014002:Tin Fluorides; C058026:polyvinylmethoxyethylene-maleic anhydride copolymer; D014260:Triclosan; D012969:Sodium Fluoride; C009285:sodium polymetaphosphate