| Objective To evaluate the anticaries effect of 1100 ppm fluoride toothpaste and modified antimicrobial toothpaste in preschool children by ICDAS in a 14-month clinical trial.Methods This was a 12-month randomized,controlled,double-blind,3 parallel clinical study based on kindergarten.The study protocol and informed consent were approved by the Ethics Committee of Peking University School and Hospital of Stomatology.Children aged 3-4 years old in the 7 kindergartens in Miyun District,Beijing were recruited to the study,and their parents were asked to sign an informed consent before the study started.All 3-4-year-old children in the selected class completed the baseline oral health examination and Cariostat caries activity test.Caries were diagnosed and recorded according to International Caries Detection and Assessment System(ICDAS).Then the children were selected on the basis of inclusion and exclusion criteria.According to the results of Cariostat caries activity test at baseline,all recruited children were stratified and randomly allocated into 3 groups:fluoride toothpaste group,modified antibacterial toothpaste group and control group(non-fluoride toothpaste group).The ratio of the number of children in the three groups was 5:3:5.Kindergarten teachers,children and parents have to participate in the oral health promotion program by dentists every semester.The children should brush their teeth three times a day with the crest children's toothbrush and corresponding toothpaste products.Besides,they will brush their teeth under the supervision of kindergarten teachers after breakfast and lunch.When they were at home,they brushed teeth under the supervision of their parents before going to bed.All children were asked to brush their teeth for 120 seconds each time with a timer.After toothbrushing for 14 months,the end-point clinical examination was conducted by the same examiners.Independent sample t-test,one-way ANOVA,Mann Whitney rank sum test and chi square test were used to compare the differences among the groups.Results A total of 916 children from 7 kindergartens in Miyun district,Beijing,completed baseline oral health examination and Cariostat caries activity test.Results showed that incipient caries were found in all children,and there was no tooth missing due to decay.77.6%of the children had cavitated caries with ICDAS score of 3 or above.The mean d3-6ft/d3-6fs scores were 4.56±4.43/8.68±10.10.The mean d1-2t/d1-2s scores were 9.93±3.68/35.87 ± 11.54,and the mean d1-6ft/d1-6fs scores were14.49±3.39/44.55±15.59.The incipient caries with ICDAS score of 1-2 were common,accounting for 68.5%of decayed,missing and filled teeth,and for 80.5%of decayed,missing and filled surfaces.According to the inclusion and exclusion criteria,677 children were included into the study.After stratified random grouping,there were 260 children in the fluoride toothpaste group,156 children in the modified antibacterial toothpaste group,and 261 children in the control group.There was no statistically significant difference among the children in the three groups in terms of the demographic variables,caries prevalence and caries severity at baseline(P>0.05).A total of 584 children completed the oral health examination at 14 months after the study began,among them,216 children in the fluoride toothpaste group,137 children in the modified antibacterial toothpaste group and 231 children in the control group.The drop-out rates in the three groups were 16.9%?12.2%?11.5%,respectively.The results showed that,during the 14 months of study,the mean increments in d1-6mft scores(0.81±2.52)and the d3-6mfs scores(6.82±6.33)in the fluoride toothpaste group were lower than those in the modified antibacterial toothpaste group(0.99±2.77,6.89±6.30)and the non-fluoride toothpaste group(1.25 ±2.53,6.95 ± 5.88).However,there were no statistically significant differences among three groups(P>0.05).In addition,in the children with low Cariostat value,the mean increment d1-6mft scores was 0.02±11.54 in the fluoride toothpaste group,which was lower than that in the modified antibacterial toothpaste group(4.27±13.39)and control group(6.02±11.59).There was significant difference in the mean increment d1-6mft scores between the fluoride toothpaste group and the control group(P<0.05).The mean increment d1-2S scores of children in the fluoride toothpaste group and the modified antibacterial toothpaste group decreased,but the difference between the two groups was not statistically significant(P>0.05).The incipient caries surfaces of children in the control group increased,and the difference between the fluoride group and control group was statistically significant(P<0.05).Conclusions No statistically significant anticaries effect of 1100pm fluoride toothpaste and new modified antibacterial toothpaste was found in children aged 3-4 years after toothbrushing for 14 months.For children with low Cariostat score at baseline,was found in children who brushed their teeth with 1100ppm fluoride toothpaste compared to those who brushed with toothpaste without fluoride. |
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