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Randomized Clinical Trial on Sodium Fluoride with Tricalcium Phosphate.

ABSTRACT: This 24-mo randomized controlled trial was based on a double-blind parallel design, and it compared the effectiveness of 2 fluoride application protocols in arresting dentine caries in primary teeth. Three-year-old children with active dentine caries were recruited and randomly allocated to 2 treatment groups. Children in group A received a semiannual application of a 25% silver nitrate (AgNO₃) solution followed by a commercially available varnish with 5% sodium fluoride (NaF) on the carious tooth surfaces. Children in group B received a semiannual application of a 25% AgNO₃ solution followed by another commercially available varnish with 5% NaF containing functionalized tricalcium phosphate (fTCP). Carious tooth surfaces that were hard when probing were classified as arrested. Intention-to-treat analysis and a hierarchical generalized linear model were undertaken. A total of 408 children with 1,831 tooth surfaces with active dentine caries were recruited at baseline, and 356 children (87%) with 1,607 tooth surfaces (88%) were assessed after 24?mo. At the 24-mo evaluation, the mean (SD) number of arrested carious tooth surfaces per child were 1.8 (2.2) and 2.6 (3.3) for group A (without fTCP) and group B (with fTCP), respectively (P = 0.003). The arrest rates at the tooth surface level were 42% for group A and 57% for group B (P < 0.001). Results of the hierarchical generalized linear model indicated that protocol B (with fTCP) had a higher predicted probability (PP = 0.656) in arresting dentine caries than protocol A (without fTCP; PP = 0.500) when the carious lesions were on buccal/lingual surfaces, were on anterior teeth, had dental plaque coverage, and were in children from low-income families (P = 0.046). In conclusion, protocol B, which applied a 25% AgNO₃ solution followed by a commercially available 5% NaF varnish with fTCP semiannually, is more effective in arresting dentine caries in primary teeth as compared with protocol A, which applied a 25% AgNO₃ solution followed by another commercially available 5% NaF varnish without fTCP semiannually (ClinicalTrials.gov NCT03423797).

SUBMITTER: Chen KJ

PROVIDER: S-EPMC7754823 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Randomized Clinical Trial on Sodium Fluoride with Tricalcium Phosphate.

Chen K J KJ Gao S S SS Duangthip D D Lo E C M ECM Chu C H CH

Journal of dental research 20200831 1

This 24-mo randomized controlled trial was based on a double-blind parallel design, and it compared the effectiveness of 2 fluoride application protocols in arresting dentine caries in primary teeth. Three-year-old children with active dentine caries were recruited and randomly allocated to 2 treatment groups. Children in group A received a semiannual application of a 25% silver nitrate (AgNO<sub>3</sub>) solution followed by a commercially available varnish with 5% sodium fluoride (NaF) on the ...[more]

PMID: 32866050

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Project description:BACKGROUND:Dental caries in primary teeth is prevalent, affecting millions of children around the world. Functionalized tricalcium phosphate (fTCP) has been incorporated into sodium fluoride (NaF) varnish to enhance the remineralization process. NaF varnish with the adjunctive application of silver nitrate (AgNO3) solution is effective in arresting dentine caries. So far, there is no published randomized clinical trial investigating the effectiveness of the adoption of AgNO3 solution and NaF varnish containing fTCP in arresting dentine caries in preschool children. The objective of this study is to compare the effectiveness of a 25% AgNO3 solution plus a 5% NaF varnish containing fTCP and a 25% AgNO3 solution plus a 5% NaF varnish in arresting coronal dentine caries among preschool children when applied semi-annually over a 30-month period. METHODS/DESIGN:This is a randomized, double-blind controlled trial. The null hypothesis tested is that no difference exists between the effectiveness of a 25% AgNO3 solution plus a 5% NaF varnish with fTCP and a 25% AgNO3 solution plus a 5% NaF varnish in arresting dentine caries in preschool children when applied semi-annually. According to the sample size calculation, approximately 2000 3- to 4-year-old kindergarten children will be screened, and at least 408 children with coronal dentine caries will be recruited. The children will be randomly allocated to two treatment groups via stratified randomization: group A - biannual application of a 25% AgNO3 solution followed by a 5% NaF varnish, and group B - biannual application of a 25% AgNO3 solution followed by a 5% NaF varnish with fTCP. Clinical examinations will be conducted every 6 months to assess whether the carious lesions have become arrested (primary outcome). Confounding factors, such as demographic background and oral hygiene behaviors, will be collected through a parental questionnaire. DISCUSSION:The effectiveness of the topical application of a 25% AgNO3 solution followed by a 5% NaF varnish with fTCP in arresting coronal dentine caries among preschool children remains unknown. Because the proposed caries-arresting methods are simple, noninvasive and low cost, these can be widely recommended for caries control in young children. TRIAL REGISTRATION:ClinicalTrials.gov (U.S.): NCT03423797 on 6 February 2018.

Project description:BackgroundEarly childhood caries (ECC) is the most prevalent chronic health problem in young children, and it can be arrested using professionally applied fluoride such as Sodium fluoride (NaF) varnish and Silver Diamine Fluoride (SDF). This trial compared two interventions to arrest ECC lesions: 38% SDF combined with 5% NaF varnish versus 38% SDF and assessed whether the arrest rate was affected by baseline lesion severity measured by ICDAS.MethodsChildren aged ≤ 4 years from 4 nurseries in a rural area in Alexandria, Egypt joined the study in March 2022. They were included if they had at least one active carious lesion with ICDAS codes ≥ 3. They were randomized to receive either 38% SDF with 5% NaF varnish or 38% SDF alone. In both groups, the agents were applied at baseline and after 6 months on the caries lesions. NaF was additionally applied on all teeth in the oral cavity, and it was also applied after three months. The primary outcome was lesion arrest status after six months. Parents' satisfaction with their children's appearance was the secondary outcome. Pearson Chi-Square test was used for bivariate comparison and multi-level multiple logistic regression was used to assess the effect of the intervention on caries arrest controlling for confounders. The interaction between the intervention and baseline lesion severity (categorized into moderate and severe lesions) was assessed and the p value was calculated.ResultsThe study included 1606 lesions in 220 children, median (IQR) age = 48(9) months. The percentages of arrested lesions after the application of SDF + NaF and SDF only were 77.7% and 73.2% (p = 0.035). In multivariable analysis, SDF + NaF had significantly greater caries arrest effect than SDF alone (AOR = 2.12, p = 0.03) with significant difference (p = 0.03) between moderate (AOR = 4.10, p = 0.005) and advanced (AOR = 1.92, p = 0.08) lesions. Most parents were satisfied with their children's appearance with no significant difference between groups (SDF + NaF = 84.5%, SDF = 78.18%, p = 0.23).ConclusionSDF + NaF had a higher arrest rate than SDF alone and this difference was significant in moderate but not advanced lesions. The findings have implications for the non-invasive management of ECC.Trial registrationThis trial was registered in the clinicaltrials.gov registry (#NCT05642494).

Project description:IntroductionDental caries is the most common chronic childhood disease. Products of metabolism by bacteria populating the tooth surface induce development and progression of cavities.ObjectivesWe sought to determine whether a polyvinylpyrrolidone-iodine (PVP-I; povidone-iodine) and NaF topical varnish was superior to one containing only NaF in prevention of new dental caries lesions in a single-center randomized active-controlled trial based on a double-blind, parallel-group design.MethodsThe site was Pohnpei State, Federated States of Micronesia. The study population was healthy children 49 to 84 mo old who were enrolled in early childhood education: 284 were randomized (1:1 allocation), and 273 were included in year 1 analysis and 262 in year 2. The test varnish contained 10% PVP-I and 5.0% NaF. The comparator contained only 5.0% NaF but was otherwise identical. Varnishes were applied every 3 mo during 2 y. The primary outcome was the surface-level primary molar caries lesion increment (d2-4mfs) at 2 y. Caries lesion increments from baseline to year 1 and year 2 were compared between conditions with log-linear regression, adjusting for age and sex and whether the tooth was sound at baseline (free of caries lesions).ResultsAt year 1, the caries lesion increment for primary molars sound at baseline was 0.9 surfaces (SD = 1.5) for the test varnish versus 1.8 (SD = 2.2) for the comparator varnish with fluoride alone (adjusted rate ratio, 0.50; 95% CI, 0.31 to 0.81; P = .005). At year 2, the caries lesion increment for primary molars sound at baseline was 2.3 surfaces (SD = 2.8) for the test varnish as compared with 3.3 (SD = 2.7) for the comparator (adjusted rate ratio, 0.74; 95% CI, 0.52 to 1.03; P = .073). Teeth that were already cavitated at baseline did not show a preventive effect. There were no harms.ConclusionsA dental varnish containing PVP-I and NaF is effective in the primary prevention of cavities in the primary dentition (NCT03082196).Knowledge transfer statementThis study demonstrates that periodic application of a varnish containing NaF and PVP-I is effective in prevention of caries lesions and useful in assessing the potential of combined treatment.

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Randomized Clinical Trial on Sodium Fluoride with Tricalcium Phosphate.

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Randomized Clinical Trial on Sodium Fluoride with Tricalcium Phosphate.

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