A controlled 6-month clinical trial to study the effects of a stannous fluoride dentifrice on gingivitis.

Abstract

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.

• Authors: Mark Mallatt, Suru Mankodi, Karen Bauroth, Samer A Bsoul, Robert D Bartizek, Tao He
• Journal: Journal of clinical periodontology (J Clin Periodontol) Vol. 34 Issue 9 Pg. 762-7 (Sep 2007) ISSN: 0303-6979 [Print] United States
• PMID: 17645550 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Dentifrices
• Phosphates
• Tin Fluorides
• hexametaphosphate

Topics

• Adolescent
• Adult
• Aged
• Dental Plaque (prevention & control)
• Dental Plaque Index
• Dental Prophylaxis
• Dentifrices (therapeutic use)
• Double-Blind Method
• Female
• Gingival Hemorrhage (prevention & control)
• Gingivitis (prevention & control)
• Humans
• Male
• Middle Aged
• Periodontal Index
• Phosphates (administration & dosage, therapeutic use)
• Tin Fluorides (administration & dosage, therapeutic use)
• Treatment Outcome