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New proposal of silver diamine fluoride use in arresting approximal caries: study protocol for a randomized controlled trial.

ABSTRACT: Approximal surfaces are a challenge to caries lesions control. Silver diamine fluoride (SDF) is a simple,low-cost and promisor intervention for arresting caries lesions, but it has never been tested on approximal surfaces. Our aim is to evaluate the efficacy and cost-efficacy of SDF in arresting initial lesions compared to resin infiltration and exclusively flossing (control group). Our second aim is to assess discomfort and satisfaction regarding interventions.This is a randomized clinical trial, double-blinded, placebo-controlled study. Children/adolescents presenting at least one approximal initial caries lesion in primary molars/permanent premolars and molars will be included. Surfaces with advanced dentine lesions identified by radiography and participants who refuse to participate or present negative behaviors will be excluded. A minimum sample size of 504 surfaces will be required for each subgroup. Individuals will be randomly allocated in three groups of interventions: SDF, resin infiltration, and control group. Depending on the allocation, the patients will receive the active treatment and respective placebo therapies. All patients will be oriented to daily flossing the included surfaces. Our primary outcome will be caries progression by clinical and radiographic examinations. Appointments will be timed and costs of materials will be considered to calculate cost-efficacy. Patient discomfort will be assessed after interventions. Parent and patient satisfaction with the treatment will be collected after treatment and in the last follow-up visit. Individuals will be assessed at 1 and 3 months after treatment to evaluate dental biofilm and at 6, 12, and 24 months to assess caries progression by visual examination and/or radiography. Multilevel analyses will be used to verify if the type of treatment influenced on the tested outcomes. Costs will be compared and analyses of cost-efficacy will be performed. Poisson analysis will test the association between intervention and reported discomfort and satisfaction.Our hypothesis is that SDF is the most cost-efficacious option from all tested interventions. If our hypothesis is confirmed, the use of SDF in private and public contexts could represent an easier and effective option in the treatment of enamel approximal caries in children/adolescents.ClinicalTrials.gov (NCT01477385), Initial release: 11/16/2011: last update: 06/02/2014.

SUBMITTER: Mattos-Silveira J

PROVIDER: S-EPMC4255679 | biostudies-literature | 2014 Nov

REPOSITORIES: biostudies-literature

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New proposal of silver diamine fluoride use in arresting approximal caries: study protocol for a randomized controlled trial.

Mattos-Silveira Juliana J Floriano Isabela I Ferreira Fernanda R FR Viganó Maria E F ME Frizzo M A MA Reyes Alessandra A Novaes Tatiane F TF Moriyama Caroline M CM Raggio Daniela P DP Imparato José C P JC Mendes Fausto M FM Braga Mariana M MM

Trials 20141119

<h4>Background</h4>Approximal surfaces are a challenge to caries lesions control. Silver diamine fluoride (SDF) is a simple,low-cost and promisor intervention for arresting caries lesions, but it has never been tested on approximal surfaces. Our aim is to evaluate the efficacy and cost-efficacy of SDF in arresting initial lesions compared to resin infiltration and exclusively flossing (control group). Our second aim is to assess discomfort and satisfaction regarding interventions.<h4>Methods/des ...[more]

PMID: 25409545

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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: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: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: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: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:BackgroundTooth 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.ObjectiveThe 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.MethodsThis 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.ResultsThis 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.ConclusionsIf 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 registrationHKU 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.

Project description:BackgroundDental caries is a serious public health issue globally. It is one of the most prevalent chronic disease in children worldwide. An important public health concern is the existence of one or more decayed, missing, or filled tooth surfaces in any primary teeth of preschool children. Early childhood caries (ECC) can be halted with the use of silver diamine fluoride (SDF) solution. Previous research has indicated that it may have a preventive impact in the treatment of ECC. It is well known that 38% silver diamine fluoride (SDF) is helpful at preventing dental caries. On the other hand, there is not enough evidence on SDF's ability to prevent caries in primary teeth. To date, no well-planned clinical study has been carried out to investigate SDF's impact on caries protection.ObjectiveThe study's objective is to evaluate and compare the efficacy of 12%, 30%, and 38% silver diamine fluoride in preventing ECC in children aged 24 to 72 months in Mangaluru Taluk.MethodsThis is a single-center, randomized, active-controlled, parallel-group pragmatic trial. Children attending preschool in Mangalore Taluk aged 24 to 72 months will be included in the study. There will be three study groups: group 1 will receive 12% SDF semiannually; group 2 will receive 30% SDF semiannually; and group 3 will receive 38% SDF semiannually. After 6 and 12 months, the principal examiner will conduct a clinical examination of the teeth with a visual and tactile assessment. The effectiveness of the various concentrations of SDF will be determined after 12 months.ResultsThe research was funded in September 2020, and data collection started in September 2022. As of February 2023, 150 participants have enrolled in the study. The project is still underway, and it is expected to be completed in December 2023.ConclusionsUncertainty surrounds the efficacy of 38% SDF in preventing ECC. Consensus-Based Clinical Case Reporting (CARE) guidelines recommending the use of SDF for ECC prevention will be modified if the findings are as expected. Additionally, since the findings will be broadly disseminated, more nations will implement the use of SDF, easing the burden of ECC on the entire world. Future research on the treatment and prevention of ECC will benefit from the study results. If SDF is successful in preventing caries in a classroom or community context, it will mark an important turning point for preventive dentistry.Trial registrationClinical Trial Registry of India CTRI/2020/02/023420; https://tinyurl.com/3ju2apab.International registered report identifier (irrid)PRR1-10.2196/46144.

Project description:BACKGROUND:Interest in aqueous silver diamine fluoride (SDF) has been growing as a treatment for caries arrest. A cross-sectional study was conducted to identify factors associated with caregiver acceptance of SDF treatment for children presenting with caries at 8 Federally Qualified Health Centers. The study purpose was to examine associations between caregiver acceptance of SDF treatment for children with caries and (1) sociodemographic and acculturation characteristics of caregivers and (2) clinical assessments of the children by dentists. METHODS:A caregiver survey collected information on: sociodemographic characteristics; acculturation characteristics, measured using the validated Short Acculturation Scale for Hispanics (SASH); perceived benefits and barriers of SDF treatment, including caregiver comfort; and perceived health-related knowledge. Chart reviews were conducted to assess: the medical / dental insurance of pediatric patients; cumulative caries experience, measured using decayed, missing, filled teeth total scores (dmft / DMFT); whether operating room treatment was needed; and a record of caregiver acceptance of SDF treatment (the outcome measure). Standard logistic regression models were developed for caregiver acceptance of SDF treatment for their children as the binary outcome of interest (yes / no) to calculate unadjusted odds ratios (OR) and adjusted ORs for covariates of interest. RESULTS:Overall, 434 of 546 caregivers (79.5%) accepted SDF treatment for their children. A U-shaped relationship between caregiver odds of accepting SDF treatment and age group of pediatric patients was present, where caregivers were most likely to accept SDF treatment for their children who were either <?6?years or 9-14?years, and least likely to accept SDF treatment for children 6 to <?9?years. The relationship between acculturation and caregiver acceptance of SDF treatment depended upon whether or not caregivers were born in the United States: greater acculturation was associated with caregiver acceptance of SDF treatment among caregivers born in this country, and lower acculturation was associated with caregiver acceptance of SDF treatment among caregivers born elsewhere. CONCLUSIONS:Caregiver acceptance of SDF treatment is high; child's age and caregiver comfort are associated with acceptance. Providers need to communicate the risks and benefits of evidence-based dental treatments to increasingly diverse caregiver and patient populations.

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New proposal of silver diamine fluoride use in arresting approximal caries: study protocol for a randomized controlled trial.

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New proposal of silver diamine fluoride use in arresting approximal caries: study protocol for a randomized controlled trial.

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