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Impact of the radiographic examination on diagnosis and treatment decision of caries lesions in primary teeth--the Caries Detection in Children (CARDEC-01) trial: study protocol for a randomized controlled trial.

ABSTRACT: 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.

SUBMITTER: Mendes FM

PROVIDER: S-EPMC4746806 | biostudies-literature | 2016 Feb

REPOSITORIES: biostudies-literature

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Impact of the radiographic examination on diagnosis and treatment decision of caries lesions in primary teeth--the Caries Detection in Children (CARDEC-01) trial: study protocol for a randomized controlled trial.

Mendes Fausto Medeiros FM Pontes Laura Regina Antunes LR Gimenez Thais T Lara Juan Sebastian JS de Camargo Lucila Basto LB Michel-Crosato Edgard E Pannuti Claudio Mendes CM Raggio Daniela Prócida DP Braga Mariana Minatel MM Novaes Tatiane Fernandes TF

Trials 20160209

<h4>Background</h4>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, h ...[more]

PMID: 26857821

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Project description:BackgroundDental caries is one of the most prevalent non-communicable disease globally and can have serious health sequelae impacting negatively on quality of life. In the UK most adults experience dental caries during their lifetime and the 2009 Adult Dental Health Survey reported that 85% of adults have at least one dental restoration. Conservative removal of tooth tissue for both primary and secondary caries reduces the risk of failure due to tooth-restoration, complex fracture as well as remaining tooth surfaces being less vulnerable to further caries. However, despite its prevalence there is no consensus on how much caries to remove prior to placing a restoration to achieve optimal outcomes. Evidence for selective compared to complete or near-complete caries removal suggests there may be benefits for selective removal in sustaining tooth vitality, therefore avoiding abscess formation and pain, so eliminating the need for more complex and costly treatment or eventual tooth loss. However, the evidence is of low scientific quality and mainly gleaned from studies in primary teeth.MethodThis is a pragmatic, multi-centre, two-arm patient randomised controlled clinical trial including an internal pilot set in primary dental care in Scotland and England. Dental health professionals will recruit 623 participants over 12-years of age with deep carious lesions in their permanent posterior teeth. Participants will have a single tooth randomised to either the selective caries removal or complete caries removal treatment arm. Baseline measures and outcome data (during the 3-year follow-up period) will be assessed through clinical examination, patient questionnaires and NHS databases. A mixed-method process evaluation will complement the clinical and economic outcome evaluation and examine implementation, mechanisms of impact and context. The primary outcome at three years is sustained tooth vitality. The primary economic outcome is net benefit modelled over a lifetime horizon. Clinical secondary outcomes include pulp exposure, progession of caries, restoration failure; as well as patient-centred and economic outcomes.DiscussionSCRiPT will provide evidence for the most clinically effective and cost-beneficial approach to managing deep carious lesions in permanent posterior teeth in primary care. This will support general dental practitioners, patients and policy makers in decision making. Trial Registration Trial registry: ISRCTN.Trial registration numberISRCTN76503940. Date of Registration: 30.10.2019. URL of trial registry record: https://www.isrctn.com/ISRCTN76503940?q=ISRCTN76503940%20&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10&searchType=basic-search .

Project description:BackgroundFew studies have addressed the clinical parameters' predictive power related to caries lesion associated with their progression. This study assessed the predictive validity and proposed simplified models to predict short-term caries progression using clinical parameters related to caries lesion activity status.MethodsThe occlusal surfaces of primary molars, presenting no frank cavitation, were examined according to the following clinical predictors: colour, luster, cavitation, texture, and clinical depth. After one year, children were re-evaluated using the International Caries Detection and Assessment System to assess caries lesion progression. Progression was set as the outcome to be predicted. Univariate multilevel Poisson models were fitted to test each of the independent variables (clinical features) as predictors of short-term caries progression. The multimodel inference was made based on the Akaike Information Criteria and C statistic. Afterwards, plausible interactions among some of the variables were tested in the models to evaluate the benefit of combining these variables when assessing caries lesions.Results205 children (750 surfaces) presented no frank cavitations at the baseline. After one year, 147 children were reassessed (70%). Finally, 128 children (733 surfaces) presented complete baseline data and had included primary teeth to be reassessed. Approximately 9% of the reassessed surfaces showed caries progression. Among the univariate models created with each one of these variables, the model containing the surface integrity as a predictor had the lowest AIC (364.5). Univariate predictive models tended to present better goodness-of-fit (AICs < 388) and discrimination (C:0.959-0.966) than those combining parameters (AIC:365-393, C:0.958-0.961). When only non-cavitated surfaces were considered, roughness compounded the model that better predicted the lesions' progression (AIC = 217.7, C:0.91).ConclusionsUnivariate model fitted considering the presence of cavitation show the best predictive goodness-of-fit and discrimination. For non-cavitated lesions, the simplest way to predict those lesions that tend to progress is by assessing enamel roughness. In general, the evaluation of other conjoint parameters seems unnecessary for all non-frankly cavitated lesions.

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:BackgroundMinimally 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.ObjectivesTo 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 methodsFifty 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.ResultsThe 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.

Dataset Information

Impact of the radiographic examination on diagnosis and treatment decision of caries lesions in primary teeth--the Caries Detection in Children (CARDEC-01) trial: study protocol for a randomized controlled trial.

Publications

Impact of the radiographic examination on diagnosis and treatment decision of caries lesions in primary teeth--the Caries Detection in Children (CARDEC-01) trial: study protocol for a randomized controlled trial.

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