Different formulas of topical
fluoride have been used to manage root
carious lesions. This clinical trial aimed to investigate the efficacy of a dental varnish containing
casein phosphopeptide-
amorphous calcium phosphate (
CPP-ACP) and
fluoride compared with
fluoride alone in reversing/arresting
root caries in xerostomic patients over 1 year. A total of 80 patients (age range 45-92 years) with primary
root caries (n = 184 root
carious lesions) and unstimulated salivary flow rate of <0.2 mL/min were randomly allocated to receive either dental varnish containing
CPP-ACP and 5%
fluoride (group 1: MI varnish; GC, Japan) (n = 41, 83 lesions), or dental varnish with 5%
fluoride alone (group 2:
NUPRO White;
Dentsply, USA) (n = 39, 101 lesions). Clinical assessments with Severity Index (SI) for
root caries, DIAGNOdent measurements, and varnish application were carried out at baseline, 3, 6, and 12 months. Standard
oral hygiene instructions with 1,450 ppm
fluoride toothpastes were provided for both groups. After 3 months, 63.9% (n = 46) of
root caries in group 1 became hard (SI: 0) compared with 39.3% (n = 35) in group 2 (p < 0.01). After 6 and 12 months, the differences in SI were insignificant (group 1, n = 60, 83.3%) (group 2, n = 66, 74.2%) (p = 0.36), and (group 1, n = 60, 89.6%) (group 2, n = 67, 81.7%, n = 1 soft, 1.2%) (p = 0.29), respectively. In both groups, noncavitated leathery lesions were more likely to become hard when compared to the cavitated
root caries. A significant decrease in plaque index, surface roughness, lesion dimension, and DIAGNOdent readings with a significant increase in lesion distance from the gingival margin was reported in both groups (p < 0.05). This study has provided evidence that
fluoride dental varnish either with or without
calcium and
phosphate has the potential to arrest/reverse
root caries, especially noncavitated lesions for patients with
xerostomia.