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Clinical effectiveness/child-patient and parent satisfaction of two topical fluoride treatments for caries: a randomised clinical trial.

ABSTRACT: Knowledge gaps exist regarding optimal silver diammine fluoride (SDF) regimens and the efficacy of new products for arresting dental caries in young children. We evaluated the effectiveness of 38%-SDF (SDI-RivaStar), Tiefenfluorid (TF) comparing with Placebo (P), all in conjunction with behavioural modification (BM), in preventing major complications (endodontic/extractions/pain)-a patient-centred outcome-due to early childhood caries over 12 months in children under 71-months. A six-arm, patient/parent-blinded, superiority, placebo-controlled randomised control trial at the university clinic in Riga, Latvia, from 1/9/20-31/8/22 (Protocol registration ISRCTN17005348). The trial tested six protocols, using three compounds (P/SDF/TF) under two regimes: annual and biannual (P1/P2/TF1/TF2/SDF1/SDF2) for major complications. Secondary outcomes included minor complications and parental satisfaction. All groups received BM. 373/427 randomised children (87.3%) completed the study. SDF2 had a significantly lower rate and risk of major (21.5%, OR = 0.28, 95%CI [0.11, 0.72], p < 0.05) and minor complications (OR = 0.16 (95%CI [0.05, 0.50], p = 0.002). Overall satisfaction was 96% (p > 0.05). SDF biannual application with BM effectively prevented major complications of early childhood caries and was well accepted by children and their parents. Trial registration number: ISRCTN17005348, principal investigator: Ilze Maldupa, registration date: 30/06/2021.Clinical trial registration number: ISRCTN registry: ISRCTN17005348, https://doi.org/10.1186/ISRCTN17005348 , registration date: 30/06/2021.

SUBMITTER: Maldupa I

PROVIDER: S-EPMC10998894 | biostudies-literature | 2024 Apr

REPOSITORIES: biostudies-literature

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Clinical effectiveness/child-patient and parent satisfaction of two topical fluoride treatments for caries: a randomised clinical trial.

Maldupa Ilze I Innes Nicola N Viduskalne Ilona I Brinkmane Anda A Senakola Egita E Krumina Karina K Uribe Sergio E SE

Scientific reports 20240407 1

Knowledge gaps exist regarding optimal silver diammine fluoride (SDF) regimens and the efficacy of new products for arresting dental caries in young children. We evaluated the effectiveness of 38%-SDF (SDI-RivaStar), Tiefenfluorid (TF) comparing with Placebo (P), all in conjunction with behavioural modification (BM), in preventing major complications (endodontic/extractions/pain)-a patient-centred outcome-due to early childhood caries over 12 months in children under 71-months. A six-arm, patien ...[more]

PMID: 38582806

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Project description:This retrospective analysis of longitudinal data was developed to determine which types, combinations, and intensities of topical fluorides more effectively prevent new caries-related restorations and extractions in high caries risk adults. We included data from October 1, 2008, through June 30, 2018, from electronic dental and medical records and pharmacy database from the US Department of Veterans Affairs. Veterans who were eligible for continuing and comprehensive care, met the criteria of high caries risk (received 2 or more caries-related restorations within a 365-d period), and had 3 y of follow-up were included. Multivariable logistic regression models estimated the odds of caries-related treatment during the 1-y observation period, controlling for age, gender, race and ethnicity, illness burden (Selim comorbidity index), use of prescription medications, attendance at dental prophylaxis appointments, number of caries-related restorations during the index year, and time between first and last caries-related restoration during the index year. The study sample included 68,757 veterans, who were primarily male (91.5%), were White (73.6%), had a mean age of 59.2 ± 13.5 y, and had significant medical comorbidity as measured by the Selim index (3.7 ± 2.4 physical and 1.3 ± 1.2 mental diagnoses). They had 10.8 ± 6.3 prescription VA drug classes, took 0.6 ± 0.8 strong anticholinergic medications, and had 3.9 ± 2.6 teeth restored due to caries during the index year. Adjusted multivariable logistic regression models showed veterans who received a varnish or gel/rinse fluoride intervention versus no fluoride had an approximately 29% decreased odds of receiving caries-related treatment during the observation period (gel/rinse adjusted odds ratio [AOR] = 0.72; 95% confidence interval [CI], 0.67-0.76; varnish AOR = 0.71; 95% CI, 0.67-0.75). The receipt of a varnish and gel/rinse did not demonstrate statistically better odds than each intervention alone (AOR = 0.69; 95% CI, 0.64-0.75). A dose-response effect was observed. Two-plus applications of varnish versus none (AOR = 0.73; 95% CI, 0.69-0.77) and 2-plus applications of gel/rinse versus none (AOR = 0.71; 95% CI, 0.67-0.75) were more effective than 1 application of either modality versus none.

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.

Project description:BackgroundA three-arm parallel group, randomised controlled trial set in general dental practices in England, Scotland, and Wales was undertaken to evaluate three strategies to manage dental caries in primary teeth. Children, with at least one primary molar with caries into dentine, were randomised to receive Conventional with best practice prevention (C + P), Biological with best practice prevention (B + P), or best practice Prevention Alone (PA).MethodsData on costs were collected via case report forms completed by clinical staff at every visit. The co-primary outcomes were incidence of, and number of episodes of, dental pain and/or infection avoided. The three strategies were ranked in order of mean cost and a more costly strategy was compared with a less costly strategy in terms of incremental cost-effectiveness. Costs and outcomes were discounted at 3.5%.ResultsA total of 1144 children were randomised with data on 1058 children (C + P n = 352, B + P n = 352, PA n = 354) used in the analysis. On average, it costs £230 to manage dental caries in primary teeth over a period of up to 36 months. Managing children in PA was, on average, £19 (97.5% CI: -£18 to £55) less costly than managing those in B + P. In terms of effectiveness, on average, there were fewer incidences of, (- 0.06; 97.5% CI: - 0.14 to 0.02) and fewer episodes of dental pain and/or infection (- 0.14; 97.5% CI: - 0.29 to 0.71) in B + P compared to PA. C + P was unlikely to be considered cost-effective, as it was more costly and less effective than B + P.ConclusionsThe mean cost of a child avoiding any dental pain and/or infection (incidence) was £330 and the mean cost per episode of dental pain and/or infection avoided was £130. At these thresholds B + P has the highest probability of being considered cost-effective. Over the willingness to pay thresholds considered, the probability of B + P being considered cost-effective never exceeded 75%.Trial registrationThe trial was prospectively registered with the ISRCTN (reference number ISRCTN77044005) on the 26th January 2009 and East of Scotland Research Ethics Committee provided ethical approved (REC reference: 12/ES/0047).

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:BackgroundSilver 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/designThis 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.DiscussionThis 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 registrationClinicalTrials.gov NCT04399369 . Registered on May 2020.

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.

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Clinical effectiveness/child-patient and parent satisfaction of two topical fluoride treatments for caries: a randomised clinical trial.

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Clinical effectiveness/child-patient and parent satisfaction of two topical fluoride treatments for caries: a randomised clinical trial.

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