Efficacy of conventional fluoridated toothpastes containing arginine and high-fluoride toothpastes on the control of root caries in patients undergone radiotherapy of head-and-neck: a randomized controlled trial

This parallel, triple-blind RCT evaluated the restorative performance of a resin-modified glass-ionomer-cement (RMGIC) in irradiated patients and the prevention of root caries lesions adjacent to restoration, comparing the effect of conventional (control) concentration, high-fluoride (F) containing fTCP and arginine-based toothpastes. A total of 63 lesions was screened and 60 were included into randomized distribution into three groups (N- participants in baseline/n- root caries lesions): G1 = 1,450 ppm F (N = 10/n = 17); G2 = 5,000 ppm F + fTCP (N = 7/n = 18) and G3 = 1,450 ppm F + arginine + CaCO3 (N = 6/n = 25). Based on eligibility criteria, all patients were mandatory enrolled after completed 3-month of radiotherapy of head-and-neck. Two calibrated operators performed the restorative procedures (RMGIC - Vitremer) and two calibrated examiners (Kappa = 0.94) evaluated the restorations based on modified USPHS criteria at baseline, 1, 3 and 6-month follow-up. Data was collected and statistically assessed with Kruskal-Wallis test (p 0.05). Even with oral complications caused by radiation-therapy, if the restorations are properly performed and patients are under professional supervision, high-F presented similar efficacy of arginine and conventional-containing toothpastes to prevent secondary caries. Clinical relevance: This clinical trial brings new evidences about the regular use of high-F, arginine-based and conventional-F containing toothpastes in irradiated patients under supervision of a multidisciplinary team and the encouragement of self-cooperation.