Data on the effectiveness of stannous fluoride against gingivitis that minimize the dental staining potential of the ingredient should be included in the final report being prepared by FDA's Dental Products Plaque Subcommittee, Procter & Gamble requests in Nov. 23 comments to the group.

The comments were summarized by P&G Regulatory Affairs Manager Marlene Feder at the subcommittee's final meeting in Rockville, Md. Dec. 2-3. Specifically, Feder argued that results of company-sponsored tests detailing consumer reactions to and removeability of dental stains associated with stannous fluoride dentifrices should be summarized in the report. The language should be inserted where the subcommittee discusses the literature on stannous fluoride, P&G suggests.

The company recommends, in part, the addition of the following statement: "Studies demonstrated that dental staining with .454% stannous fluoride was noticed by a minority of consumers and could be characterized as mild to moderate."

"Moreover, studies demonstrated that staining was easily removed from both dental surfaces, and importantly, dental restorations during conventional prophylaxis procedures," P&G's suggested language continues. "This data also indicated that stain removal following use of stannous fluoride dentifrices did not require significant increases in either professional time or effort."

Stannous fluoride, the active ingredient in P&G's Crest Gum Care toothpaste, has been a topic of discussion by the panel in previous meetings. P&G said it would consider pursuing antiplaque claims for the formulation at the subcommittee's Oct. 22 session ("The Tan Sheet" Nov. 2, p. 6).

P&G's comments are "intended to enhance the scientific accuracy and readability" of the panel's final report, according to the firm. "On three separate occasions," data were presented to the group "providing further analysis and explanation supporting the safety and effectiveness of stannous fluoride for antigingivitis efficacy," the comments note.

The company also requested that information explaining clinical trials conducted on the ingredient be included in the final language. P&G recommends insertion of the statement: "Clinical studies included detailed information of soft tissues and statistical comparison of oral soft tissue safety."

The company asks that the final stannous fluoride discussion section state that results of the assays revealed "no adverse shifts among oral microbiological populations" and "no overgrowth of opportunistic pathogens." The fact the assays showed "no development of oral microbial resistance to stannous fluoride" should additionally be included, P&G says.

P&G also requests the subcommittee consider the inclusion of detailed results on the clinical benefit following use of .454% stannous fluoride, including data on the ingredient's ability to prevent and treat gingivitis and gingival bleeding.

The company advises that the final report acknowledge "available clinical data do not show reproducible long-term effects for stannous fluoride dentifrice in the reduction of dental plaque mass formed on teeth; however, clinical data do clearly indicate that stannous fluoride is effective in inhibiting the damaging effects of plaque in promoting gingivitis."

The firm additionally suggests the subcommittee allow for an "optional indication" for antigingivitis products containing the ingredient, which would read: "[stannous fluoride] helps interfere with the harmful effects of plaque associated with gingivitis. The panel believes that stronger antiplaque claims may be possible should sufficient data be presented in the future."

Subcommittee member William Bowen, PhD, University of Rochester, volunteered to review P&G's comments regarding inclusion of the clinical data and present his findings to the subcommittee.

P&G requests for the inclusion of other data regarding the safety of stannous fluoride, however, were not accepted by the subcommittee. The data include details from six clinical trials on the safety of the ingredient in various dosage forms.

P&G's Feder noted the company's support for comments submitted by the Nonprescription Drug Manufacturers Association and the Cosmetic, Toiletry & Fragrance Association joint task group, which also requests additional scientific data be included in the final report ("The Tan Sheet" Dec. 7, p. 12).

Stannous Fluoride "Mild" Staining Characterization Sought In Plaque Report

More from Archive

More from Pink Sheet