Dataset Information

The antibacterial effect of nanosilver fluoride in relation to caries activity in primary teeth: a protocol for a randomized controlled clinical trial.

ABSTRACT:

Background

Minimally invasive dentistry is a highly convenient and efficient method of managing caries in pediatric patients. Silver diamine fluoride (SDF) is commonly used to arrest active caries lesions. However, the associated black stain, possibility of soft tissue injury, and unpleasant taste often limit its use. Recently, nanosilver fluoride (NSF) emerged as a promising topical fluoride agent with potent cariostatic and antibacterial potentials. This novel anticaries agent has gained attention as an alternative to overcome the drawbacks of SDF in caries arrest.

Objectives

To assess the antibacterial effect of NSF in relation to caries activity in dentin caries lesions, as well as to investigate the change in saliva bacterial levels in primary teeth in comparison to SDF after 1 and 3 months.

Materials and methods

Fifty children aged 4 to 6 years old with active dentin caries lesions (score 5 according to International Detection and Assessment System (ICDAS II) criteria) will be enrolled in the study. They will be equally and randomly allocated into 2 groups: a group receiving NSF and a control group receiving SDF treatment. Microbiological samples will be collected from the carious lesions and from unstimulated saliva at the baseline and at the 1 and 3 months' follow-up appointments. Bacterial counts will be assessed using Mitis Salivarius agar (selective culture media for S. mutans) and Rogosa agar (selective culture media for lactobacilli), and the results will be expressed in colony-forming units. Data regarding the children's oral health will be collected and their dmf index will be scored. The arrest of active carious lesions will be measured at the follow-up appointments according to ICDAS II criteria.

Results

The relation between bacterial colony counts and lesion activity for both groups will be assessed, as well as the change in salivary bacterial counts. The collected data will be statistically evaluated and tabulated. This clinical trial has been registered on ClinicalTrials.gov in January 2022 (original version) with ID: NCT05221749.

SUBMITTER: Ammar N

PROVIDER: S-EPMC9264752 | biostudies-literature |

REPOSITORIES: biostudies-literature

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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: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.

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:BackgroundApproximal 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.Methods/designThis 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.DiscussionOur 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.Trial registrationClinicalTrials.gov (NCT01477385), Initial release: 11/16/2011: last update: 06/02/2014.

Project description:Although most clinical guidelines throughout the world indicate that clinicians take two bitewings for detecting caries lesions in primary molars of all children, evidence for this recommendation is essentially based on cross-sectional studies performed in laboratory settings or using convenience samples. The benefits and impact of performing radiographs on diagnosis and treatment decision of caries lesions in primary teeth, mainly considering relevant outcomes for patients, have not been evaluated yet. Thus, the aim of this randomized clinical trial will be to evaluate the impact of performing radiographic examination adjunct to the visual inspection for detecting and making treatment decision regarding caries lesions in primary teeth compared with visual inspection performed alone. We will consider different outcomes related to children's health and welfare.To reach this objective, 250 children ages 3 to 6 years who sought dental treatment in our dental school will be randomly allocated in two groups according to the diagnostic strategy used for caries detection: visual inspection performed alone or visual inspection associated to radiographic examination. Two trained and calibrated examiners will carry out the examinations and elaborate the treatment decision plan. Then, children will be treated and followed up for 2 years, with evaluations after 12 and 24 months after the inclusion of children in the study. Children will also return after 6 and 18 months to reinforce the preventive orientations. Primary outcome will be the number of dental surfaces in need of dental treatment at the follow-up. Secondary outcomes will be the components of the primary outcome separately, as well as, proportion of false-positive results, the oral health-related quality of life, cost-efficacy, cost-adjusted life years, and number of new lesions in the first permanent molars.Our working hypothesis is that radiographic examination would actually exert little influence on patient-centered outcomes, and visual inspection would be enough as diagnostic strategy for caries detection in primary teeth.NCT02078453. Registered 4 March 2015.

Project description:Background : Fluoridation of public water systems is known as a safe and effective strategy for preventing dental caries based on evidence from non-randomized studies. Yet 110 million Americans do not have access to a fluoridated public water system and many others do not drink tap water. This article describes the study protocol for the first randomized controlled trial (RCT) of fluoridated water that assesses its potential dental caries preventive efficacy when delivered in bottles. Methods : waterBEST is a phase 2b proof-of-concept, randomized, quadruple-masked, placebo controlled, parallel group, trial designed to estimate the potential efficacy of fluoridated versus non-fluoridated bottled water to prevent dental caries incidence in the first four years of life. Two hundred children living in eastern North Carolina, USA, and aged 2-6 months at screening are being allocated at random in a 1:1 ratio to receive fluoridated (0.7 mg/L F) or non-fluoridated bottled water sourced from two local public water systems. Throughout the 3.5-year intervention, study water is delivered monthly in 5-gallon bottles to each child's home with instructions to use it whenever the child consumes water as a beverage or in food preparation. Parents are interviewed quarterly to monitor children's water consumption and health. At annual visits, the presence of dental caries is evaluated with a dental screening examination. Clippings from fingernails and toenails are collected to quantify fluoride content as a biomarker of total fluoride intake. The primary endpoint is the number of primary tooth surfaces decayed, missing, or filled due to dental caries measured by the study dentist near the time of the child's fourth birthday. Tooth decay is assessed at the threshold of macroscopic enamel loss. For the primary aim, a least-squares, generalized linear model will estimate efficacy and its one-tailed, upper 80% confidence limit. Discussion: waterBEST is the first evaluation of a randomized intervention of fluoridated drinking water in bottles to prevent dental caries in the primary dentition. This innovative method of delivering fluoridated water has potential to prevent early childhood caries in a large segment of the U.S. population that currently does not benefit from fluoridated public water. Trial registration : ClinicalTrials.gov (NCT04893681). Registered March 2022. Last update posted 2023-10-10. https://clinicaltrials.gov/study/NCT04893681?cond=Dental%20Caries%20in%20Children&term=fluoride&locStr=North%20Carolina,%20USA&country=United%20 States&state=North%20Carolina&distance=50&rank=1.

Project description:BackgroundFluoridation of public water systems is known as a safe and effective strategy for preventing dental caries based on evidence from non-randomized studies. Yet 110 million Americans do not have access to a fluoridated public water system and many others do not drink tap water. This article describes the study protocol for the first randomized controlled trial (RCT) of fluoridated water that assesses its potential dental caries preventive efficacy when delivered in bottles.MethodswaterBEST is a phase 2b proof-of-concept, randomized, quadruple-masked, placebo-controlled, parallel-group trial designed to estimate the potential efficacy of fluoridated versus non-fluoridated bottled water to prevent dental caries incidence in the first 4 years of life. Two hundred children living in eastern North Carolina, USA, and aged 2-6 months at screening are being allocated at random in a 1:1 ratio to receive fluoridated (0.7 mg/L F) or non-fluoridated bottled water sourced from two local public water systems. Throughout the 3.5-year intervention, study water is delivered monthly in 5-gallon bottles to each child's home with instructions to use it whenever the child consumes water as a beverage or in food preparation. Parents are interviewed quarterly to monitor children's water consumption and health. At annual visits, the presence of dental caries is evaluated with a dental screening examination. Clippings from fingernails and toenails are collected to quantify fluoride content as a biomarker of total fluoride intake. The primary endpoint is the number of primary tooth surfaces decayed, missing, or filled due to dental caries measured by the study dentist near the time of the child's fourth birthday. Tooth decay is assessed at the threshold of macroscopic enamel loss. For the primary aim, a least-squares, generalized linear model will estimate efficacy and its one-tailed, upper 80% confidence limit.DiscussionwaterBEST is the first evaluation of a randomized intervention of fluoridated drinking water in bottles to prevent dental caries in the primary dentition. This innovative method of delivering fluoridated water has the potential to prevent early childhood caries in a large segment of the US population that currently does not benefit from fluoridated public water.Trial registrationClinicalTrials.gov NCT04893681. Registered on March 2022. Last update posted on 10 October 2023. https://clinicaltrials.gov/study/NCT04893681?cond=Dental%20Caries%20in%20Children&term=fluoride&locStr=North%20Carolina,%20USA&country=United%20States&state=North%20Carolina&distance=50&rank=1.