1. The Relative Anticaries Effectiveness of Three Fluoride-Containing Dentifrices in Puerto Rico

The Relative Anticaries Effectiveness of Three Fluoride-Containing Dentifrices in Puerto Rico

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Reference: Stookey GK, Mau MS, Isaacs RL, Gonzalez-Gierbolini C, Bartizek RD, Biesbrock AR. Caries Res. 2004;38:542-550.

CONCLUSION

In a 2-year clinical trial, subjects in both the high-dose sodium fluoride dentifrice (2,800 ppm F) group and the 0.454% stabilized stannous fluoride dentifrice (SnF2, 1,100 ppm F) group showed significantly fewer caries increments than subjects in the sodium fluoride positive control dentifrice group (1,100 ppm F). The low-NaF group (550 ppm F) and the positive control group did not differ.

OBJECTIVE

To compare the anticaries effectiveness of a low-dose (500 ppm F) and high-dose (2,800 ppm F) sodium fluoride dentifrice (low-NaF and high Na-F) and an experimental dentifrice (SnF2; 1,100 ppm F) with a sodium fluoride positive control dentifrice (1,100 ppm F) over 2 years. (Note: This was an early prototype of the eventual marketed stannous fluoride/sodium hexametaphosphate product.)

MATERIALS AND METHODS

  • The four dentifrices compared were as follows: an experimental dentifrice (0.454% SnF2 and sodium hexametaphosphate for cosmetic benefits), low-NaF, high-NaF,positive control.
  • Study subjects were 955 schoolchildren (~9-12 years) from an urban area in Puerto Rico.
  • Subjects were randomly assigned to the four treatments and were supplied with their dentifrice and toothbrushes, which were replaced every 3 months. Their 1-minute toothbrushing was supervised twice a day by teachers in the classroom; brushing was ad libitum outside school hours.
  • Caries were assessed by visual-tactile examinations (with aid of fiber-optic illumination and artificial light, mouth mirror, compressed air, dental explorer) as DMFS (decayed, missing, and filled surfaces) by two examiners and supplemented with a radiographic examination at baseline and after 12 and 24 months.
  • Both examiners examined all subjects. Examiners were tested for the sensitivity and specificity of their examinations and repeatability of their results prior to the study.

RESULTS

  • 799 subjects completed the year 1 assessment; 683 subjects were re-examined at year 2.
  • Considering evaluable subjects (i.e., those who attended at least 60% of the supervised brushing sessions over the 2-year study period):
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    - Both examiners showed that caries increments were lower in the high-NaF group than the control group.

    - Both examiners showed statistically significantly less caries in the SnF2 group than the positive control group.

    - Neither examiner showed statistically significant differences in caries increments between low-NaF and positive control groups.

Two-year caries increment results for evaluable subjects
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