A controlled 6-month clinical trial to study the effects of a stannous fluoride dentifrice on gingivitis.
OBJECTIVE
This study was conducted to assess anti-plaque and anti-gingivitis benefits of a stabilized stannous fluoride (SnF(2))/sodium hexametaphosphate (SHMP) dentifrice versus a negative control.


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% SnF(2)/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 SnF(2) dentifrice delivered a 16.9% reduction in gingivitis (p<0.001), a 40.8% reduction (p<0.001) in gingival bleeding, and an 8.5% reduction in plaque (p=0.001) versus the negative control. Both treatments were well tolerated.


CONCLUSIONS
Twice daily use of the SnF(2)/SHMP dentifrice over 6 months provided statistically significant anti-plaque and anti-gingivitis benefits relative to a negative control.
Mallatt
Mark
M
Indiana State Department of Health, Indianapolis, IN, USA.
Mankodi
Suru
S
Bauroth
Karen
K
Bsoul
Samer A
SA
Bartizek
Robert D
RD
He
Tao
T
D000293:Adolescent; D000328:Adult; D000368:Aged; D003773:Dental Plaque / Q000517:prevention & control*; D003774:Dental Plaque Index; D003777:Dental Prophylaxis; D003802:Dentifrices / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005884:Gingival Hemorrhage / Q000517:prevention & control; D005891:Gingivitis / Q000517:prevention & control*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010512:Periodontal Index; D010710:Phosphates / Q000008:administration & dosage / Q000627:therapeutic use*; D014002:Tin Fluorides / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
D003802:Dentifrices; D010710:Phosphates; D014002:Tin Fluorides; C005035:hexametaphosphate