I R Freire1, J P Pessan1, J G Amaral1, C C R Martinhon1, R F Cunha1, A C B Delbem2. 1. Department of Pediatric Dentistry and Public Health, Araçatuba Dental School, Univ. Estadual Paulista (UNESP), Araçatuba, SP, Brazil; Rua José Bonifácio, 1193, 16015-050 Araçatuba, SP, Brazil. 2. Department of Pediatric Dentistry and Public Health, Araçatuba Dental School, Univ. Estadual Paulista (UNESP), Araçatuba, SP, Brazil; Rua José Bonifácio, 1193, 16015-050 Araçatuba, SP, Brazil. Electronic address: adelbem@foa.unesp.br.
Abstract
UNLABELLED: Low-fluoride dentifrices (LFD) have been recommended for young children aiming to minimize excessive fluoride intake during tooth brushing. Given the uncertainties surrounding the clinical efficacy of such formulations, alternatives to increase their anticaries effect have been investigated. OBJECTIVES: This double-blind, randomized controlled trial assessed the clinical efficacy of LFDs supplemented with Calcium Glycerophosphate (CaGP) or Sodium Trimetaphosphate (TMP) on the progression of dental caries in the deciduous dentition. METHODS:Children (average age 48 months old) from two Brazilian cities (Araçatuba and Fernandópolis) were randomly assigned into 3 groups, according to the dentifrice to be used: 500ppm F plus 1% TMP ("500TMP", n=206), 500ppm F plus 0.25% CaGP ("500CaGP, n=201) and 1100ppm F ('1100F', n=193). Clinical exams (dmfs) were performed at baseline and 18 months after dentifrices started to be used, and the increment in the number of carious lesions (final dmfs - initial dmfs) was calculated. Data were analyzed by multivariate linear regression analysis to verify the influence of city, gender, previous caries experience and type of dentifrice on dmfs increment (p<0.05). RESULTS:Mean caries increment observed for 500TMP (0.26) was significantly lower when compared with 1100F (0.74), while values found for 500CaGP (0.54) were not significantly different from 1100F. Caries increment was significantly higher in children from Araçatuba and in those with previous caries experience. CONCLUSION: The results indicate that clinical efficacy of LFDs supplemented with TMP is superior to that observed for a conventional formulation (1100F), while the addition of CaGP leads to similar efficacy when compared to 1100F. CLINICAL SIGNIFICANCE: Children brushing with 500ppm F toothpastes containing phosphate salts developed fewer caries lesions when compared with those using a 1100ppm F dentifrice. The tested toothpastes can be regarded as a safe alternative to conventional formulations for children under 6 years of age, based on risk-benefit considerations.
RCT Entities:
UNLABELLED: Low-fluoride dentifrices (LFD) have been recommended for young children aiming to minimize excessive fluoride intake during tooth brushing. Given the uncertainties surrounding the clinical efficacy of such formulations, alternatives to increase their anticaries effect have been investigated. OBJECTIVES: This double-blind, randomized controlled trial assessed the clinical efficacy of LFDs supplemented with Calcium Glycerophosphate (CaGP) or Sodium Trimetaphosphate (TMP) on the progression of dental caries in the deciduous dentition. METHODS:Children (average age 48 months old) from two Brazilian cities (Araçatuba and Fernandópolis) were randomly assigned into 3 groups, according to the dentifrice to be used: 500ppm F plus 1% TMP ("500TMP", n=206), 500ppm F plus 0.25% CaGP ("500CaGP, n=201) and 1100ppm F ('1100F', n=193). Clinical exams (dmfs) were performed at baseline and 18 months after dentifrices started to be used, and the increment in the number of carious lesions (final dmfs - initial dmfs) was calculated. Data were analyzed by multivariate linear regression analysis to verify the influence of city, gender, previous caries experience and type of dentifrice on dmfs increment (p<0.05). RESULTS: Mean caries increment observed for 500TMP (0.26) was significantly lower when compared with 1100F (0.74), while values found for 500CaGP (0.54) were not significantly different from 1100F. Caries increment was significantly higher in children from Araçatuba and in those with previous caries experience. CONCLUSION: The results indicate that clinical efficacy of LFDs supplemented with TMP is superior to that observed for a conventional formulation (1100F), while the addition of CaGP leads to similar efficacy when compared to 1100F. CLINICAL SIGNIFICANCE: Children brushing with 500ppm F toothpastes containing phosphate salts developed fewer caries lesions when compared with those using a 1100ppm F dentifrice. The tested toothpastes can be regarded as a safe alternative to conventional formulations for children under 6 years of age, based on risk-benefit considerations.