The Caries-Arrest Effectiveness of Silver Diamine Fluoride Treatment with Different Post-Treatment Instructions in Preschool Children: A Study Protocol for a Randomized Controlled Trial.
Ontology highlight
ABSTRACT:
SUBMITTER: Sun IG
PROVIDER: S-EPMC10297061 | biostudies-literature | 2023 Jun
REPOSITORIES: biostudies-literature
Publications
The Caries-Arrest Effectiveness of Silver Diamine Fluoride Treatment with Different Post-Treatment Instructions in Preschool Children: A Study Protocol for a Randomized Controlled Trial.
Sun Ivy Guofang IG Duangthip Duangporn D Lo Edward Chin Man ECM Chu Chun Hung CH
Dentistry journal 20230605 6
In this 12-month randomized active-controlled clinical trial, we compare two post-treatment instructions for silver diamine fluoride (SDF) therapy in arresting dentine caries. The trial will include at least 254 kindergarten children with active dentine caries. The children will be randomized into two groups and receive a 38% SDF solution applied topically to their carious lesions. Children in Group A will rinse immediately, whereas those in Group B will refrain from rinsing, eating, and drinkin ...[more]
Similar Datasets
Project description:ObjectivesThe Stopping Cavities Trial investigated effectiveness and safety of 38% silver diamine fluoride in arresting caries lesions.Materials and methodsThe study was a double-blind randomized placebo-controlled superiority trial with 2 parallel groups. The sites were Oregon preschools. Sixty-six preschool children with ≥1 lesion were enrolled. Silver diamine fluoride (38%) or placebo (blue-tinted water), applied topically to the lesion. The primary endpoint was caries arrest (lesion inactivity, Nyvad criteria) 14-21days post intervention. Dental plaque was collected from all children, and microbial composition was assessed by RNA sequencing from 2 lesions and 1 unaffected surface before treatment and at follow-up for 3 children from each group.Results and conclusionAverage proportion of arrested caries lesions in the silver diamine fluoride group was higher (0.72; 95% CI; 0.55, 0.84) than in the placebo group (0.05; 95% CI; 0.00, 0.16). Confirmatory analysis using generalized estimating equation log-linear regression, based on the number of arrested lesions and accounting for the number of treated surfaces and length of follow-up, indicates the risk of arrested caries was significantly higher in the treatment group (relative risk, 17.3; 95% CI: 4.3 to 69.4). No harms were observed. RNA sequencing analysis identified no consistent changes in relative abundance of caries-associated microbes, nor emergence of antibiotic or metal resistance gene expression. Topical 38% silver diamine fluoride is effective and safe in arresting cavities in preschool children.Clinical significanceThe treatment is applicable to primary care practice and may reduce the burden of untreated tooth decay in the population.
| S-EPMC5748247 | biostudies-literature
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.
| S-EPMC9171591 | biostudies-literature
Project description:Background: The World Health Organisation (WHO) included silver diamine fluoride (SDF) in the WHO Model List of Essential Medicines for the management of early childhood caries. SDF is typically available as a 38% aqueous solution, which is watery to apply. A 38% SDF gel has recently been developed, but its caries-arrest effectiveness remains unsubstantiated. The objective of this study is to determine whether the efficacy of a 38% SDF gel is non-inferior to a 38% SDF solution in arresting early childhood caries. Methods: This is a 30-month, randomised, active-controlled, parallel-group non-inferiority pragmatic clinical trial with two arms. The hypothesis is that the 38% SDF gel is not worse than the 38% SDF solution by a non-inferiority margin of 10% caries-arrest rate when applied semi-annually to preschool children. This trial will recruit 630 3-year-old kindergarten children through block randomisation to receive either an application of SDF gel or SDF solution on cavitated carious lesions in their primary teeth every 6 months. The primary outcome is the proportion of soft (active) carious tooth surfaces that turn hard (arrested) at the 30-month follow-up. The same calibrated dentist will conduct 6-monthly dental examinations in the kindergartens to assess the status of carious lesions over 30 months. The examiner, the children, and parents will be blinded to treatments. The parents will be surveyed on their child's oral health-related behaviours and socioeconomic background to allow adjustment for effect modification. Results: If the anticipated results are obtained, clinicians can use the 38% SDF gel as an alternative of the 38% SDF solution in arresting early childhood caries. Conclusions: As SDF gel is cost-effective, non-invasive, and non-aerosol-generating, it can be widely recommended for caries control. Trial registration: ClinicalTrials.gov NCT06241261. Registered on 7 February 2024.
| S-EPMC11674657 | biostudies-literature
Project description:ImportanceDental caries is the most common global childhood disease. To control caries, the Centers for Disease Control and Prevention recommends school-based caries prevention, and the World Health Organization lists glass ionomer cement and silver diamine fluoride as essential medicines for oral disease.ObjectiveTo determine the noninferiority of silver diamine fluoride with fluoride varnish vs traditional glass ionomer sealants with fluoride varnish after 2 years when provided to children via a school-based health care program.Design, setting, and participantsThe CariedAway study is an ongoing single-blind, cluster randomized, noninferiority trial conducted between February 1, 2019, and June 1, 2023, among 2998 children in 47 New York City primary schools. Children aged 5 to 13 years of any race and ethnicity were recruited from block-randomized schools. Inclusion criteria for schools were a student population of at least 50% Hispanic or Latino or Latina ethnicity and/or Black race and at least 80% of students receiving free or reduced-cost lunch. Statistical analysis is reported through March 2022.InterventionsChildren received a single application of silver diamine fluoride with fluoride varnish or an active comparator of glass ionomer sealants and atraumatic restorations with fluoride varnish.Main outcomes and measuresPrimary outcomes were caries arrest and incidence after a 2-year follow-up, assessed using mixed-effects multilevel models and clustered 2-sample proportion tests. The noninferiority margin was 10%. Intention-to-treat analysis was performed using multiple imputation.ResultsA total of 2998 children (1566 girls [52.2%]; mean [SD] age at baseline, 6.6 [1.2] years; 1397 Hispanic or Latino or Latina children [46.6%]; 874 [29.2%] with untreated dental caries) were recruited and treated from September 16, 2019, to March 12, 2020. Follow-up observations were completed for 1398 children from June 7, 2021, to March 2, 2022. The mean (SE) proportion of children with arrested caries was 0.56 (0.04) after experimental treatment and 0.46 (0.04) after control treatment (difference, -0.11; 95% CI, -0.22 to 0.01). The mean (SE) proportion of patients without new caries was 0.81 (0.02) after experimental treatment and 0.82 (0.02) after control treatment (difference, 0.01; 95% CI, -0.04 to 0.06). Analysis of imputed data for the full sample did not deviate from per-protocol analyses. There were no adverse events.Conclusions and relevanceIn this randomized clinical trial, silver diamine fluoride with fluoride varnish was noninferior to sealants and atraumatic restorations with fluoride varnish for caries arrest and prevention. Results may support the use of silver diamine fluoride as an arresting and preventive agent in school-based oral health programs.Trial registrationClinicalTrials.gov Identifier: NCT03442309.
| S-EPMC9912124 | biostudies-literature
Project description:ObjectiveThis clinical trial aimed to compare the caries-preventive effect of annual application of 38% silver diamine fluoride solution (SDF) with 5% sodium fluoride varnish (FV) to the anterior primary teeth of children. The hypothesis was that SDF was superior to FV at 1 year. Secondary objectives were to determine the child's cooperation and the parent's satisfaction and assess adverse effects.MethodWe recruited 688 3- to 4-year-old children and randomly allocated them to receive SDF or FV (positive control) on their 6 upper anterior teeth. Tooth-surface status was recorded using the decayed, missing, and filled surfaces index. A trained observer rated the child's cooperation as "totally cooperative" or "not totally cooperative." We used a questionnaire to determine the parent's satisfaction as "satisfied," "neutral," or "dissatisfied." Adverse effects (yes/no) were evaluated 1 day and about 1 year after treatment.ResultsOf the children, 434 (SDF, n = 209; FV, n = 225) completed the trial. The mean new decayed tooth surfaces developed for SDF and FV groups were 0.4 ± 1.5 and 0.4 ± 1.3, respectively (P = .65). Child's cooperation for SDF and FV therapy was 71% (244/344) and 70% (241/344), respectively (P = .89). Parent's satisfaction for SDF and FV therapy was 71% (148/209) and 69% (155/225), respectively (P = .29). Adverse effects were found neither at 1 day nor at about 1 year after treatment for either treatment arm.ConclusionsSDF is not superior to FV for caries prevention in primary upper anterior teeth at 1-year follow-up. Child's cooperation and parent's satisfaction were similarly high with SDF and FV therapy at 1-year follow-up. Neither short-term nor long-term adverse effects were observed. This study is registered at ClinicalTrials.gov (NCT04399369).
| S-EPMC10509425 | biostudies-literature
Project description:The objective of this pilot study was to describe the microbial profiles present in the plaque and saliva of children who continued to develop new carious lesions following treatment with silver diamine fluoride ("nonresponders") compared to caries active, caries-free, and children immediately receiving SDF treatment for untreated caries in order to identify potential microbial differences that may relate to a re-incidence of caries. Saliva and plaque samples from infected and contralateral sites were obtained from twenty children who were either caries free, had active carious lesions, were caries active and received SDF treatment immediately before sampling, or had previously received SDF treatment and developed new caries. In total, 8,057,899 Illumina-generated sequence reads from 60 samples were obtained. Reads were processed using the Quantitative Insights Into Microbial Ecology pipeline. Group differences were assessed using Analysis of Variance Models and Tukey Honest Significant Differences. To identify significant taxa between treatment groups, Linear discriminant analysis Effect Size (LefSe) and Analysis of Differential Abundance Taking Sample Variation Into Account were used. Differential abundant analysis indicated that members of the Lachnospiraceae family were significantly enriched in non-responders and the genus Tannerella and species Granulicatella adiances were also highly abundant in this group. LefSe analysis between non-responders and SDF-treated groups revealed that genera Leptotrichia and Granulicatella were enriched in non-responders. We observed the highest abundance of phosphotransferase system and lowest abundance of lipopolysaccharide synthesis in non-responders. The microbiome in dental biofilms is responsible for initiation and progression of dental caries. SDF has been shown to be effective in arresting the progression carious lesions, in part due to its antimicrobial properties. Findings suggest that the differential abundance of select microbiota and specific pathway functioning in individuals that present with recurrent decay after SDF treatment may contribute to a potential failure of silver diamine fluoride to arrest dental caries. However, the short duration of sample collection following SDF application and the small sample size emphasize the need for further data and additional analysis.
| S-EPMC7959385 | biostudies-literature
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.
| S-EPMC6814040 | biostudies-literature
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).
| S-EPMC10656986 | biostudies-literature
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.
| S-EPMC5615850 | biostudies-literature
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.
| S-EPMC10548636 | biostudies-literature