Dataset Information

Addition of Povidone-Iodine to Fluoride Varnish for Dental Caries: A Randomized Clinical Trial.

ABSTRACT:

Introduction

Dental caries is the most common chronic childhood disease. Products of metabolism by bacteria populating the tooth surface induce development and progression of cavities.

Objectives

We 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.

Methods

The 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 (d_2-4mfs) 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).

Results

At 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.

Conclusions

A dental varnish containing PVP-I and NaF is effective in the primary prevention of cavities in the primary dentition (NCT03082196).

Knowledge transfer statement

This 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.

SUBMITTER: Milgrom P

PROVIDER: S-EPMC7970344 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundSilver Diamine Fluoride (SDF) has gained attention as one of the minimally invasive modalities to manage ECC although it causes black staining of treated carious lesions. A possible affordable alternative may be Sodium Fluoride (NaF) varnish combined with good oral hygiene promoted by parental Motivational Interviewing (MI). The study compared the effectiveness of 38% SDF solution and 5% NaF varnish supported by parental MI in arresting ECC.Materials and methodsChildren aged ≤ 4 years old with at least one active carious lesion (ICDAS score ≥ 3) were randomly assigned to treatment by a single application of 38% SDF solution or a single application of 5% NaF varnish supported by two MI sessions for mothers at baseline and after three months. Chi-Squared test was used to compare groups and multilevel logistic regression analysis was used to assess the effect of the interventions on ECC arrest adjusting for confounders. The interaction between the type of intervention and baseline lesion severity, moderate (ICDAS 3/4) or advanced (ICDAS 5/6), was also assessed.ResultsThe study included 165 children with 949 active lesions. After 6 months, there were no significant differences between SDF and NaF/MI groups in overall caries arrest (63.7% and 58.1%, p = 0.08), and in moderate lesions (72.9% and 69.6%, p = 0.52). However, in advanced lesions, the arrest rate was significantly higher in the SDF than the NaF/ MI group (60.3% and 50.0%, P = 0.01). Multilevel multiple logistic regression showed no significant differences between the interventions (AOR = 1.56, P = 0.27) with significant interaction between the intervention and baseline lesion severity (p < 0.001). Moderate lesions treated with SDF (AOR = 3.69, P = 0.008) or NaF/MI (AOR = 3.32, P < 0.001) had significantly higher odds of arrest than advanced lesions treated with NaF/ MI with no difference between advanced lesions treated with SDF or NaF/ MI (AOR = 1.85, P = 0.155) in arrest rate.ConclusionNaF/ MI can be an alternative to SDF in arresting advanced and moderate ECC lesions without staining with stronger effect on moderate lesions (ICDAS 3/4).Trial registrationThe trial was retrospectively registered at clinicaltrial.gov registry (#NCT05761041) on 9/3/2023.

Project description:BackgroundCombined use of povidone iodine (PI) along with topical fluorides (TF) has been suggested as a promising strategy to reduce dental caries incidence and cariogenic bacterial load. However, the available literature presents mixed evidence regarding its effectiveness as compared to TF application alone.Aim and objective'TF + PI' vs TF alone in the prevention of dental caries among 1-12-year-old children assessed through caries increment and mean S. mutans and Lactobacillus counts.Materials and methodsFive databases (Cochrane Central Register of Controlled Trials, EBSCOhost, PubMed/Medline, Scopus, and Web of Science) were searched for relevant literature. Out of 72 studies that were screened, 7 eligible studies were included out of which 4 studies were subjected to meta-analysis. The generic inverse variance test was used to assess the primary outcome reported as mean ± SD/events occurred (caries incidence), whereas for mean post-intervention S. mutans colony count, inverse variance function was used. The Cochrane's Collaboration tool and Modified Downs and Black scoring criteria were used to evaluate the quality of the included articles. Heterogeneity across the studies was assessed using the I 2 statistic. Statistical significance was set at p < 0.05.ResultsOverall, for primary and permanent dentition combined, the dental caries incidence was found to be significantly lower in the 'TF + PI' combined therapy group as compared to TF alone [SMD -0.4 (-0.78 to -0.03), p = 0.04]. The two groups showed no significant difference with respect to post-intervention S. mutans count [SMD -0.1 (-0.57 to +0.37), p = 0.69]. No study was found that compared post-intervention Lactobacillus count between the two groups.ConclusionBased on the pooled analysis from the limited literature available, there is a very low quality of evidence that 'TF + PI' combined therapy is more effective in the prevention of new caries lesions among 1-12-year-old children as compared to TF use alone. Future clinical trials with robust methodologies are recommended to generate conclusive evidence.Clinical significancePI application might exert an added benefit with TF in preventing the occurrence of new carious lesions among 1-12-year-old children.How to cite this articleGupta A, Nishant, Sharda S, et al. Comparing the Effectiveness of Topical Fluoride and Povidone Iodine with Topical Fluoride Alone for the Prevention of Dental Caries among Children: A Systematic Review and Meta-analysis. Int J Clin Pediatr Dent 2020;13(5):559-565.

Project description:ImportanceDental caries is the world's most prevalent noncommunicable disease and a source of health inequity; school dental sealant programs are a common preventive measure. Silver diamine fluoride (SDF) may provide an alternative therapy to prevent and control caries if shown to be noninferior to sealant treatment.ObjectiveTo determine whether school-based application of SDF is noninferior to dental sealants and atraumatic restorative treatment (ART) in the prevalence of dental caries.Design, setting, and participantsThe Silver Diamine Fluoride Versus Therapeutic Sealants for the Arrest and Prevention of Dental Caries in Low-Income Minority Children (CariedAway) study was a pragmatic noninferiority cluster-randomized clinical trial conducted from February 2018 to June 2023 to compare silver diamine fluoride vs therapeutic sealants for the arrest and prevention of dental caries. Children at primary schools in New York, New York, with at least 50% of the student population reporting as Black or Hispanic and at least 80% receiving free or reduced lunch were included. This population was selected as they are at the highest risk of caries in New York. Students were randomized to receive either SDF or sealant with ART; those aged 5 to 13 years were included in the analysis. Treatment was provided at every visit based on need, and the number of visits varied by child. Schools with preexisting oral health programs were excluded, as were children who did not speak English. Of 17 741 students assessed for eligibility, 7418 were randomized, and 4100 completed follow-up and were included in the final analysis.InterventionsParticipants were randomized at the school level to receive either a 38% concentration SDF solution or glass ionomer sealants and ART. Each participant also received fluoride varnish.Main outcomes and measuresPrimary study outcomes were the prevalence and incidence of dental caries.ResultsA total of 7418 children (mean [SD] age, 7.58 [1.90] years; 4006 [54.0%] female; 125 [1.7%] Asian, 1246 [16.8%] Black, 3648 [49.2%] Hispanic, 153 [2.1%] White, 114 [1.5%] multiple races or ethnicities, 90 [1.2%] other [unspecified], 2042 [27.5%] unreported) were enrolled and randomized to receive either SDF (n = 3739) or sealants with ART (n = 3679). After initial treatment, 4100 participants (55.0%) completed at least 1 follow-up observation. The overall baseline prevalence of dental caries was approximately 27.2% (95% CI, 25.7-28.6). The odds of decay prevalence decreased longitudinally (odds ratio [OR], 0.79; 95% CI, 0.75-0.83) and SDF was noninferior compared to sealants and ART (OR, 0.94; 95% CI, 0.80-1.11). The crude incidence of dental caries in children treated with SDF was 10.2 per 1000 tooth-years vs 9.8 per 1000 tooth-years in children treated with sealants and ART (rate ratio, 1.05; 95% CI, 0.97-1.12).Conclusions and relevanceIn this school-based pragmatic randomized clinical trial, application of SDF resulted in nearly identical caries incidence compared to dental sealants and ART and was noninferior in the longitudinal prevalence of caries. These findings suggest that SDF may provide an effective alternative for use in school caries prevention.Trial registrationClinicalTrials.gov Identifier: NCT03442309.

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:This randomized, parallel, controlled trial assessed the effect of fluoride varnish, ozone and octenidine on white spot lesions (WSLs) and caries during orthodontic treatment. Patients were enrolled between 1st September 2017 and 31st August 2020 at initiation of orthodontic treatment in Department of Interdisciplinary Dentistry Pomeranian Medical University in Szczecin, Poland. All participants were randomly assigned to four study and one control groups using number random generator. However, investigators were not blinded due to the nature of the study. Groups I, II, III, IV had professional cleaning and varnishing (5% NaF) every 4 weeks. Groups II and IV had in-office ozone therapy before varnishing, groups III and IV received domestic octenidine mouthrinse. Group K had no professional hygienic or prophylactic procedures. WSLs were assessed at T0 and then every 4 weeks (T1-T4) and caries-at T0 and T4. The specific objective was to assess the influence of fluoride varnish, ozone and octenidine on the incidence of white spot lesions and caries during orthodontic treatment. The primary outcome of this report was the highest number of WSLs in group K and the lowest percentage of patients with WSLs in group IV. Each group comprised 30 randomized participants; they were all analyzed. No WSLs were found at T0, but they were stated in all groups at T4. The numbers of patients with WSLs significantly increased between T0-T4 in groups I and K. Group IV had the lowest percentage of patients with WSLs in T1-T4. WSLs in group IV were found no earlier than at T2. Group K had the highest percentage of WSLs at T4: 26%. At T0 all the groups had DMFs above 0 with a significant increase at T4. No side effects of the introduced prophylaxis were observed in any group. Caries is an important problem of fixed orthodontic treatment. Even an extremely intensive prophylaxis could not completely prevent WSLs and caries. Simultaneous application of fluoride varnish, ozone gas exposure and octenidine appears to have a beneficial effect in limiting the development of WSLs.Trial registration: NCT04992481.

Project description:Background:Due to limited financial resources, poor access to basic oral care, and the high cost of restorative treatment, children of low-income nations have their general health, social well-being, and education opportunities affected by untreated dental caries. Arresting caries treatment (ACT) has been proposed to manage untreated dental caries in children of disadvantaged communities. Aims and objectives:The purpose of the present controlled clinical trial is to investigate the effectiveness of a new anticaries agent, nanosilver fluoride (NSF), preventing and arresting caries in children. Materials and methods:A total of 100 deciduous molars both maxillary and mandibular are randomly selected from 60 children of 4-9 years of age group, which were randomly divided into NSF experimental group and saline control group. Teeth were clinically diagnosed and treated by one masked examiner and followed up at 7 days, 5 months and 12 months by another calibrated examiner who was blinded to the type of treatment. The criteria of the ICDAS II were followed to determine the activity of lesion and the diagnosis of caries. The Pearson's Chi-square test was used to compare the groups during different follow-up examinations. Results:Seventy-eight percent of decayed teeth showed hard arrested dentine at 7 days; after 5-month analysis in the NSF group, 72.91% of the teeth showed arrested caries; and in the control group, only 34% of teeth showed arrest of caries. At 12-month analysis in the NSF group, 65.21% of teeth showed arrested cavities, and in the control group, 28.88% of teeth showed arrest of caries. Conclusion:The present study proves that NSF is an anticaries agent and presents a noninvasive option for caries arrest and treatment when applied directly to dentin caries lesions. How to cite this article:Nagireddy VR, Reddy D, Kondamadugu S, et al. Nanosilver Fluoride-A Paradigm Shift for Arrest in Dental Caries in Primary Teeth of Schoolchildren: A Randomized Controlled Clinical Trial. Int J Clin Pediatr Dent 2019;12(6):484-490.