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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: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: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.

Project description:The application of 38 % silver diamine fluoride (SDF) has been shown to be effective in arresting early childhood caries (ECC). Since SDF is not available in certain countries, some dentists use adjunctive application of 25 % silver nitrate (AgNO3) and 5 % sodium fluoride (NaF) to arrest ECC. This randomised controlled trial will systematically compare the efficacy of a 25 % AgNO3 solution followed by 5 % NaF varnish with that of a 38 % SDF solution in arresting ECC when applied at half-yearly intervals over a 30-month period.This study is a randomised, double-blinded, non-inferiority clinical trial. The hypothesis tested is that adjunctive application of 25 % AgNO3 followed by 5 % NaF is at least not appreciably worse than a 38 % SDF in arresting ECC. Approximately 3100 kindergarten children aged 3-4 years will be screened and at least 1070 children with caries will be recruited. This sample size is sufficient for an appropriate statistical analysis (power at 90 % (? = 0.10) with a 2-sided type-I error of ? = 0.05), allowing for an overall 20 % drop-out rate. The children will be randomly allocated into 2 groups to treat their caries over a 30-month period: Group A - biannual adjunctive application of a 25 % AgNO3 solution and a 5 % NaF varnish, and Group B - biannual adjunctive application of a 38 % SDF solution followed by a placebo varnish. Clinical examinations will be conducted at 6-month intervals. Primary outcome measured is the number of active caries surfaces which are arrested. Information on confounding factors such as oral hygiene habits will be collected through a parental questionnaire.We expect that adjunctive application of 25 % AgNO3 solution and 5 % NaF varnish and of 38 % SDF solution can both effectively arrest ECC. Lower concentrations of silver and fluoride are contained in 25 % AgNO3 and 5 % NaF, respectively, than in 38 % SDF; therefore, AgNO3/NaF are more favourable for use in young children. Because its use for caries management is painless, simple, low-cost, and approved in many countries, AgNO3/NaF could be widely recommended and promoted as an alternative treatment to conventional invasive management of ECC.ClinicalTrials.gov: NCT02019160 . Date of registration: 11 December 2013.

Project description:BACKGROUND:The caries arrest that can be achieved by using silver diamine fluoride (SDF) offers a minimally invasive and inexpensive alternative to traditional restorative caries treatment. The authors evaluated how the dentinal staining that is associated with SDF influences the acceptance of this treatment among parents of young children in the New York City metropolitan area. METHODS:The authors invited the parents of children who had experienced dental caries and who had appointments at the New York University Pediatric Dentistry Clinic and at several private clinics in New Jersey to participate in a Web-based survey designed to assess parents' demographics, perceptions of photographs of SDF-treated carious teeth, and acceptability of treatment in different behavior management scenarios. RESULTS:Ninety-eight mothers and 22 fathers from diverse backgrounds participated. Most parents (67.5%) judged SDF staining on the posterior teeth to be esthetically tolerable, but only 29.7% of parents made this same judgment about anterior teeth (P < .001). In the absence of their child having behavioral barriers to conventional restorations, 53.6% of parents reported that they were likely to choose SDF to treat their child's posterior teeth, but only 26.9% of parents were likely to choose SDF to treat their child's anterior teeth. As the number of children's behavioral barriers increased, so did the parents' level of acceptance. In extreme cases, in which parents had to decide whether their children should undergo general anesthesia during treatment, parents' acceptance rate of SDF as a treatment method increased to 68.5% on posterior teeth and to 60.3% on anterior teeth. Parents' acceptance of the treatment also varied according to their socioeconomic status. CONCLUSIONS:Staining on posterior teeth was more acceptable than staining on anterior teeth. Although staining on anterior teeth was undesirable, most parents preferred this option to advanced behavioral techniques such as sedation or general anesthesia. PRACTICAL IMPLICATIONS:Clinicians need to understand parental sensitivities regarding the staining effect of SDF to plan adequately for the use of SDF as a method of caries management in pediatric patients.

Project description:BackgroundThis umbrella review comprehensively appraised evidence for silver diamine fluoride (SDF) to arrest and prevent root and coronal caries by summarizing systematic reviews. Adverse events were explored.MethodsFollowing Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guidelines, PubMed, Embase, Cochrane Library, PROSPERO register and Joanna Briggs Institute Database of Systematic Reviews were searched for systematic reviews investigating SDF for caries prevention or arrest (1970-2018) without language restrictions. Systematic reviews were selected, data extracted, and risk of bias assessed using ROBIS by two independent reviewers, in duplicate. Corrected covered area was calculated to quantify studies' overlap across reviews.ResultsEleven systematic reviews were included; four focussing on SDF for root caries in adults and seven on coronal caries in children. These cited 30 studies (4 root caries; 26 coronal caries) appearing 63 times. Five systematic reviews were of "low", one "unclear" and five "high" risk of bias. Overlap of studies was very high (50% root caries; 17% coronal caries). High overlap and heterogeneity, mainly comparators and outcome measures, precluded meta-analysis. Results were grouped by aim and outcomes to present an overview of direction and magnitude of effect. SDF had a positive effect on prevention and arrest of coronal and root caries, consistently outperforming comparators (fluoride varnish, Atraumatic Restorative Treatment, placebo). For root caries prevention, the prevented fraction (PF) was 25-71% higher for SDF compared to placebo (two systematic reviews with three studies) and PF?=?100-725% for root caries arrest (one systematic review with two studies). For coronal caries prevention, PF?=?70-78% (two systematic reviews with two studies) and PF?=?55-96% for coronal caries arrest (one systematic review with two studies) with arrest rates of 65-91% (four systematic reviews with six studies). Eight systematic reviews reported adverse events, seven of which reported arrested lesions black staining.ConclusionSystematic reviews consistently supported SDF's effectiveness for arresting coronal caries in the primary dentition and arresting and preventing root caries in older adults for all comparators. There is insufficient evidence to draw conclusions on SDF for prevention in primary teeth and prevention and arrest in permanent teeth in children. No serious adverse events were reported.

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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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