High-Fluoride Toothpaste: A Multicenter Randomized Clinical Trial in Adults

Methods: Adult patients (n=130; Age: 18–75 years, mean age: 57.6) diagnosed with root caries, were randomly distributed in two groups. Interventions were randomly allocated to the subjects. Test group (subjects=64; lesions=144): high-fluoride toothpaste, 5000 ppm F; Control group (subjects=66; lesions 160), regular fluoridated toothpaste, 1350 ppm F. Clinical examinations were performed at baseline, 3–months and 6–months. Surface hardness of the carious lesions and laser fluorescence scores were recorded for each subject at the specified intervals. Statistical tests were carried out on subject level data.

Results: The mean surface hardness (HS) and mean laser fluorescence (DS) scores were compared between groups for different time intervals using a paired t-test (p<0.001). At baseline, HS and DS were 3.4 and 47.2, respectively. At 6–months, HS improved by 0.97±0.85 and 0.60±0.78 for the test and control groups, respectively, which was statistically significant (p=0.011). There was no statistical difference between the groups for HS scores at 3–months (p=0.13). At 6–months, DS changed to 42±17 and 46±0.18 for the test and control groups, respectively (p=0.002).

Conclusions: It can hence be concluded that twice daily use of high-fluoride toothpaste (5000 ppm) is superior to a commonly used toothpaste in arresting existing root carious lesions in adults.