Root caries arrest with high-fluoride dentifrices in community-dwelling elders, RCT

OBJECTIVES: Self‐administered non‐invasive therapy with high‐fluoride dentifrices is an attractive alternative to traditional restorative treatment, but evidence is still scarce. The aim of this randomized controlled clinical trial (RCT) was to assess the effectiveness of toothbrushing with 5,000 ppm fluoridated toothpaste (F‐toothpaste) on preventing and arresting root carious lesions, in community‐dwelling older adults. METHODS: A 24‐months double‐blinded RCT was carried out with a calculated sample size of 345 independently‐living older adults. Volunteers had to have at least 5 teeth in the mouth and one root carious lesion. Participants were randomly assigned to the arms of the study: high‐fluoride (5,000 ppm F) or conventional F‐toothpaste control (1,450 ppm F) dentifrice. Subjects were instructed to brush twice per day only with the assigned F‐toothpaste. Incidence and arrest of existing root carious lesions was recorded at 24 months and compared with the baseline data. Baseline and follow‐up clinical examinations were performed by one calibrated examiner (Kappa: 0.81). Data were compared between both arms and differences considered significant if p<0.05. RESULTS: At 24‐months, root caries incidence was 45% and 8% in the 1,450 ppm and 5,000 ppm in the F‐toothpaste group, respectively, with a relative risk (RR) of 0.16, CI: [0.14‐0.20]. From the total of active lesions at baseline, 63% remained active in the control group, but only 9% in the 5,000 ppm F toothpaste group. Conversely, 53% of the lesions shifted from inactive to active in the 1,450 ppm control group , compared to only 3% in the high‐fluoride toothpaste group. CONCLUSIONS: Results indicate that root caries lesions can be prevented and inactivated using 5,000 ppm F dentifrices. Self‐administered, non‐invasive therapy with high‐fluoride toothpastes seems an effective approach for prevention and management of root carious lesions, in community‐dwelling older adults. ClinicalTrials.gov NCT02647203.