Dataset Information

Effectiveness of Silver Diamine Fluoride for Preventing Occlusal Caries in the Primary Teeth of Preschool Children: Protocol for a Randomized Controlled Trial.

ABSTRACT:

Background

Tooth decay is a significant public health problem globally. The caries-arrest effectiveness of 38% silver diamine fluoride (SDF) has been well documented. However, information on the caries-preventive effect of SDF on primary teeth is insufficient.

Objective

The aim of this trial is to investigate the effectiveness of semiannual application of 38% SDF and that of 5% sodium fluoride (NaF) varnish when compared with placebo control for preventing occlusal caries in the primary molars of preschool children over 30 months.

Methods

This 3-arm, parallel design, double-blind, randomized controlled trial involves 791 preschool children. Children are randomly allocated to receive 1 of 3 interventions as follows: Group 1, 38% SDF; Group 2, 5% NaF varnish; and Group 3, placebo control (tonic water). The intervention and dental examination will be carried out every 6 months. A parent-administered questionnaire, including the children's demographic background and oral health-related behaviors, has been collected at baseline. Follow-up examinations to detect new caries development will be conducted every 6 months by a masked examiner. Caries development will be diagnosed at the cavitation level. Chi-square tests and logistic regression analyses will be adopted. A 2-level logistic regression analysis will be performed to investigate the effects of the study interventions and other potential confounding factors on the development of occlusal caries.

Results

This study was started on September 1, 2020, and the recruitment process ended on September 30, 2021. At present, a total of 791 children are participating in the study. This 30-month clinical trial is expected to be completed in March 2024.

Conclusions

If SDF application is more effective than NaF varnish for preventing caries on occlusal surfaces of primary teeth, it can be a preferred choice for caries prevention in a kindergarten-based program. Results of this trial will provide valuable clinical evidence for the development of oral health strategies and policies on the promotion of child oral health.

Trial registration

HKU Clinical Registry HKUCTR-2844, https://tinyurl.com/bdhz9yuk; ClinicalTrials.gov NCT05084001, https://clinicaltrials.gov/ct2/show/NCT05084001.

International registered report identifier (irrid)

DERR1-10.2196/35145.

SUBMITTER: Duangthip D

PROVIDER: S-EPMC9171591 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effectiveness of Silver Diamine Fluoride for Preventing Occlusal Caries in the Primary Teeth of Preschool Children: Protocol for a Randomized Controlled Trial.

Duangthip Duangporn D He Shuyang S Gao Sherry Shiqian SS Chu Chun Hung CH Lo Edward Chin Man ECM

JMIR research protocols 20220523 5

<h4>Background</h4>Tooth decay is a significant public health problem globally. The caries-arrest effectiveness of 38% silver diamine fluoride (SDF) has been well documented. However, information on the caries-preventive effect of SDF on primary teeth is insufficient.<h4>Objective</h4>The aim of this trial is to investigate the effectiveness of semiannual application of 38% SDF and that of 5% sodium fluoride (NaF) varnish when compared with placebo control for preventing occlusal caries in the p ...[more]

PMID: 35604758

Similar Datasets

Project description:BackgroundThe use of silver diamine fluoride (SDF) in caries treatment in children has increased despite the disadvantage of causing tooth discoloration. Nanosilver fluoride (NSF) is a possible alternative. This study aimed to assess the antibacterial effect of NSF and SDF and their impact on the activity of dentin caries in primary teeth.MethodsSynthesis and characterization of the physical and biological properties of NSF were conducted. Fifty children aged 4-6 years with dentin caries (active caries corresponding to ICDAS code 5) in deciduous teeth were randomly assigned to treatment by NSF or SDF. Baseline assessment of Streptococcus mutans (S. mutans) and lactobacilli counts as CFU/mL in caries lesions was done, followed by the application of the agents. After one month, microbiological samples were recollected, and lesion activity was reassessed. Groups were compared using Mann-Whitney and Chi-Square tests, while intragroup comparisons were done using Wilcoxon and McNemar tests. Multilevel logistic regression analysis was used to assess the effect of different variables on the outcomes.ResultsThere were 130 teeth in 50 children; mean ± SD age = 4.75 ± 0.76 years, 63% were posterior teeth. At the one-month follow-up appointment, both groups showed a significant decrease from baseline bacterial counts. There was a significant difference in the reduction of S. mutans between NSF and SDF (21.3% and 10.5%, respectively, p = 0.002), while not in lactobacilli (13.9% and 6.0%, respectively, p = 0.094). In both groups, there was a significant reduction in the number of active caries from baseline (p < 0.0001) with no significant difference between groups (percentage inactive = 64.4% and 63.4%, p = 0.903). Multilevel regression revealed non-significant differences in S. mutans and lactobacilli counts (AOR 1.281, p = 0.737 and 1.888, p = 0.341, respectively), and in the number of inactive lesions (AOR 1.355, p = 0.731) between groups.ConclusionThe short-term antibacterial efficacy of NSF was similar to that of SDF. In both groups there was a significant reduction of S. mutans and lactobacilli counts in active dentin caries, and two-thirds of the lesions became inactive with no differences between the two interventions. Further research is needed to investigate the long-term efficacy of NSF and its suitability for clinical use in caries management.Trial registrationThis trial was prospectively registered on the clinicaltrials.gov registry with ID: NCT05221749 on 03/02/2022.

Project description:BACKGROUND:Silver diamine fluoride (SDF) solution is effective in arresting early childhood caries (ECC). Previous studies have suggested that it might exert a preventive effect in managing ECC. However, no well-designed clinical trials have yet been performed to study the effect of SDF on caries prevention. The objective of this randomised clinical trial is to determine whether 38% SDF solution is superior to 5% sodium fluoride (NaF) varnish in preventing new carious lesions in primary anterior teeth. METHODS/DESIGN:This is a phase II, single-centre, randomised, double-blind, active-controlled, parallel-group pragmatic trial. The hypothesis tested is that 38% SDF would be more effective than 5% NaF in preventing new caries development in primary anterior teeth. Approximately 730 3-year-old children who are generally healthy and with parental consent will be recruited from Hong Kong kindergartens. This sample size will be sufficient for appropriate statistical analysis of a superiority trial with 90% power, allowing for a 20% drop-out rate. Stratified randomisation will be adopted for allocating the intervention. The intervention will either be 38% SDF or 5% NaF (as a positive control) therapy on primary upper anterior teeth. A single trained examiner will conduct a dental examination every 6 months until 30 months in kindergarten. Another operator will provide fluoride therapy immediately after each dental examination. The examiner, children and children's parents will be blinded to the treatment allocation. A questionnaire survey will be conducted to study the children's oral health-related behaviours and socioeconomic backgrounds. Chi-square tests, t tests, regression analyses and survival analyses will be adopted for data analysis. DISCUSSION:The effectiveness of 38% SDF in preventing ECC remains uncertain. If the results are as anticipated, care standards using 5% NaF for ECC prevention will be changed. In addition, the results will be widely available and increase the adoption of SDF in other countries to reduce the global burden of ECC. TRIAL REGISTRATION:ClinicalTrials.gov, NCT04075474. Registered on 30 Aug 2019.

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:Different regimens of silver diamine fluoride (SDF) have been used to manage early childhood caries. So far, there is limited information regarding the concentrations and frequency of applications for effective caries control in primary teeth. This study aimed to compare the efficacy of 2 commercially available SDF solutions at preprepared concentrations of 38% and 12% when applied annually or biannually over 18 mo in arresting dentine caries in primary teeth. This randomized double-blinded clinical trial recruited kindergarten children aged 3 to 4 y who had at least 1 tooth with dentine caries. The children were randomly allocated to receive 4 treatment protocols: group 1, annual application of 12% SDF; group 2, biannual application of 12% SDF; group 3, annual application of 38% SDF; and group 4, biannual application of 38% SDF. Clinical examinations at 6-mo intervals were conducted to assess whether active carious lesions became arrested. Information on the children's background and oral hygiene habits was collected through a parental questionnaire at baseline and follow-up examinations. A total of 888 children with 4,220 dentine carious tooth surfaces received treatment at baseline. After 18 mo, 831 children (94%) were examined. The caries arrest rates were 50%, 55%, 64%, and 74% for groups 1, 2, 3, and 4, respectively (P < 0.001). Lesions treated with SDF biannual application had a higher chance of becoming arrested compared with those receiving SDF annual application (odds ratio, 1.33; 95% confidence interval, 1.04-1.71; P = 0.025). The interaction between concentration and lesion site was statistically significant (P < 0.001). Compared with 12% SDF, the use of 38% SDF increased a chance of becoming arrested (P < 0.05), except lesions on occlusal surfaces. Based on the 18-mo results, SDF is more effective in arresting dentin caries in the primary teeth of preschool children at 38% concentration than 12% concentration and when applied biannually rather than annually. Knowledge Transfer Statement: The results of this study can be used by clinicians and dental public health professionals when deciding which concentrations and frequency of application of silver diamine fluoride solution should be adopted for arresting dentine caries. With consideration of caries arrest treatment with silver diamine fluoride, which is painless, simple, and low cost, this information could lead to more appropriate therapeutic decisions for caries control in young children or those who lack access to affordable conventional dental care.

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.

Dataset Information

Effectiveness of Silver Diamine Fluoride for Preventing Occlusal Caries in the Primary Teeth of Preschool Children: Protocol for a Randomized Controlled Trial.

Background

Objective

Methods

Results

Conclusions

Trial registration

International registered report identifier (irrid)

Publications

Effectiveness of Silver Diamine Fluoride for Preventing Occlusal Caries in the Primary Teeth of Preschool Children: Protocol for a Randomized Controlled Trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets