Premium
A controlled 6‐month clinical trial to study the effects of a stannous fluoride dentifrice on gingivitis
Author(s) -
Mallatt Mark,
Mankodi Suru,
Bauroth Karen,
Bsoul Samer A.,
Bartizek Robert D.,
He Tao
Publication year - 2007
Publication title -
journal of clinical periodontology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.456
H-Index - 151
eISSN - 1600-051X
pISSN - 0303-6979
DOI - 10.1111/j.1600-051x.2007.01109.x
Subject(s) - dentifrice , gingivitis , medicine , dentistry , sodium hexametaphosphate , dental plaque , randomized controlled trial , fluoride , sodium , chemistry , inorganic chemistry , organic chemistry
Objectives: 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. 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% 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.