Dataset Information

Comparing two fluoride therapies for caries management in young children: study protocol for a randomised clinical trial.

ABSTRACT:

Background

Silver diamine fluoride (SDF) and sodium fluoride (NaF) are widely used for caries management. The objectives of this study are (i) to compare the caries-arresting and caries-preventive effects of SDF and NaF in young children, (ii) to determine children's and parents' acceptance of these fluoride therapies and (iii) to investigate the short-term (1 day) and long-term (1 year) adverse effects of these fluoride therapies.

Methods/design

This is a randomised, double-blind, active-controlled clinical trial to be conducted in Hong Kong kindergartens. The study has received approval from the local institutional review board. Written consent will be obtained from the parents/guardians before the study. The study will recruit at least 688 healthy 3-year-old children. This sample size is sufficient for an appropriate statistical analysis. Stratified randomisation will be performed for intervention allocation. The two intervention groups are 38% SDF and 5% NaF varnish applied on six primary upper anterior teeth. At baseline, one trained examiner will perform clinical examinations of the children in the kindergartens. The caries experience and oral hygiene status of each child will be recorded using the decayed, missing (due to caries) and filled primary tooth index and visual plaque index, respectively. Then, an independent operator will apply the assigned fluoride after the dental examinations. The examiner, the children and their parents will be blinded to the intervention allocation. In addition, a research assistant will evaluate the child's acceptance using interval rating scales for children's uncooperative behaviour. The examiner will then visit the children the next day to study the short-term potential adverse effects of the fluoride therapies. The same examiner will perform a follow-up examination after 1 year to evaluate the children's caries experiences, their oral hygiene statuses and the adverse effects of the fluoride. Parental questionnaires will be used to assess parental satisfaction and concerns about the fluoride therapies.

Discussion

This study provides essential information about using SDF in an outreach kindergarten service for caries management from different aspects, which include the caries-arresting and caries-preventive effects, the adverse effects and children's and parents' acceptance. The success of the service can help to increase the adoption of SDF to reduce the global burden of early childhood caries.

Trial registration

ClinicalTrials.gov NCT04399369 . Registered on May 2020.

SUBMITTER: Gao SS

PROVIDER: S-EPMC8335970 | biostudies-literature |

REPOSITORIES: biostudies-literature

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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:BackgroundCombined use of povidone iodine (PI) along with topical fluorides (TF) has been suggested as a promising strategy to reduce dental caries incidence and cariogenic bacterial load. However, the available literature presents mixed evidence regarding its effectiveness as compared to TF application alone.Aim and objective'TF + PI' vs TF alone in the prevention of dental caries among 1-12-year-old children assessed through caries increment and mean S. mutans and Lactobacillus counts.Materials and methodsFive databases (Cochrane Central Register of Controlled Trials, EBSCOhost, PubMed/Medline, Scopus, and Web of Science) were searched for relevant literature. Out of 72 studies that were screened, 7 eligible studies were included out of which 4 studies were subjected to meta-analysis. The generic inverse variance test was used to assess the primary outcome reported as mean ± SD/events occurred (caries incidence), whereas for mean post-intervention S. mutans colony count, inverse variance function was used. The Cochrane's Collaboration tool and Modified Downs and Black scoring criteria were used to evaluate the quality of the included articles. Heterogeneity across the studies was assessed using the I 2 statistic. Statistical significance was set at p < 0.05.ResultsOverall, for primary and permanent dentition combined, the dental caries incidence was found to be significantly lower in the 'TF + PI' combined therapy group as compared to TF alone [SMD -0.4 (-0.78 to -0.03), p = 0.04]. The two groups showed no significant difference with respect to post-intervention S. mutans count [SMD -0.1 (-0.57 to +0.37), p = 0.69]. No study was found that compared post-intervention Lactobacillus count between the two groups.ConclusionBased on the pooled analysis from the limited literature available, there is a very low quality of evidence that 'TF + PI' combined therapy is more effective in the prevention of new caries lesions among 1-12-year-old children as compared to TF use alone. Future clinical trials with robust methodologies are recommended to generate conclusive evidence.Clinical significancePI application might exert an added benefit with TF in preventing the occurrence of new carious lesions among 1-12-year-old children.How to cite this articleGupta A, Nishant, Sharda S, et al. Comparing the Effectiveness of Topical Fluoride and Povidone Iodine with Topical Fluoride Alone for the Prevention of Dental Caries among Children: A Systematic Review and Meta-analysis. Int J Clin Pediatr Dent 2020;13(5):559-565.

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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.