Abstract
This 4-year randomized controlled trial (RCT) aimed at investigating whether routine home use of both a SnCl2/AmF/NaF-containing mouth rinse and toothpaste has a preventive effect on oral health. Fifty-four test subjects were examined in biannual intervals. The primary endpoint “dental erosion” was determined by the Basic Erosive Wear Examination (BEWE). The secondary endpoints were “saliva pH”, “dentin hypersensitivity” generated by Visual Analogue Scale (VAS), and “discoloration” measured by the Lobene Stain Index (LSI). A mixed model for repeated measures (MMRM) was used to analyze the primary endpoint “dental erosion”. Primary analysis showed a significant intervention effect of the SnCl2/AmF/NaF-containing test product (p1 = 0.0242). This result was confirmed by two additional MMRM-based sensitivity analyses. Comparison of all models showed “dental erosion” values of the intervention group below values of the control group. Discoloration of the teeth was significantly higher in the intervention than in the control group at all time points. Saliva pH and dentin hypersensitivity were not significantly different between groups over four years. In summary, this RCT is the first to indicate a possible preventive effect of SnCl2/AmF/NaF-containing oral hygiene products on dental erosion over a follow-up period of four years.
Highlights
In the treatment and prevention of dental erosion, no uniform evidence-based clinical guidelines are available
This randomized, controlled clinical trial meets current ethical standards and was performed in accordance with the relevant directives and regulations. It was conducted after obtaining approval from the ethics committee of the Medical Faculty of the University of Heidelberg in December 2012 (S-566/2012)
The study was registered at the German Clinical Trials Registry Platform (DRKS00005019, date of registration 2013/05/27) that is linked to the International Clinical Trials Registry Platform of the World Health Organization (WHO)
Summary
In the treatment and prevention of dental erosion, no uniform evidence-based clinical guidelines are available. The clinical effect of stannous fluoride containing products was demonstrated in various in situ studies[10,16,17,18] as well as in clinical investigations of several months duration[19,20]. According to the PICO format, the aim of this pilot study was to evaluate, whether the routine use of mouth rinsing solutions and tooth pastes that contain stannous, amine and sodium fluoride (SnCl2/AmF/NaF) have a positive effect on oral health with respect to dental erosion and dentin hypersensitivity in a population of athletes. It was hypothesized that the use of both a SnCl2/AmF/NaF-containing mouth rinsing solution and tooth paste leads to alterations in the manifestation of dental erosion. The null hypothesis was that SnCl2/AmF/NaF-containing mouth rinsing solutions and tooth pastes have no effect on oral health
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