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 (<i>n</i> = 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) (<i>n</i> = 41, 83 lesions), or dental varnish with 5% fluoride alone (group 2: NUPRO White; Dentsply, USA) (<i>n</i> = 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% (<i>n</i> = 46) of root caries in group 1 became hard (SI: 0) compared with 39.3% (<i>n</i> = 35) in group 2 (<i>p</i> < 0.01). After 6 and 12 months, the differences in SI were insignificant (group 1, <i>n</i> = 60, 83.3%) (group 2, <i>n</i> = 66, 74.2%) (<i>p</i> = 0.36), and (group 1, <i>n</i> = 60, 89.6%) (group 2, <i>n</i> = 67, 81.7%, <i>n</i> = 1 soft, 1.2%) (<i>p</i> = 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 (<i>p</i> < 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.
Amorphous calcium phosphate-based bioactive polymeric composites for mineralized tissue regeneration
