2-year survival and cost analysis of occlusoproximal ART restorations using encapsulated glass ionomer cement in primary molars: a randomized controlled trial.

BACKGROUND: The survival of ART restorations can be influenced by the choice of the restorative material. The aim of this randomized non-inferiority controlled trial was to compare the 2-year survival rate and cost analysis of two encapsulated glass ionomer cements (GIC) as occlusoproximal restorative materials in primary molars. METHODS: Children from public schools in Tietê (Brazil), aged 4-8 years with occlusoproximal dentine carious lesions in primary molars were selected and randomly assigned to receive either Equia Forte (EF) or Riva Self Cure (RSC) as restorative materials. Treatment was carried out by two trained final-year dental students in schools following ART premises. Restorations were assessed by a trained and calibrated examiner after 2, 6, 12, 18, and 24 months. The primary outcome was restoration survival after 2 years, analyzed using Kaplan-Meier survival and Cox regression analysis (α = 5%). Professional and materials costs for each group were collected in Brazilian Reais (R$) and converted into US dollars (US$) and analyzed using Monte-Carlo simulation. RESULTS: A total of 152 children (76 per group) were included in the study, and 121 (79%) were evaluated after 2 years. The overall 2-year restoration survival rate was 39% (EF = 45%; RSC = 32%) with no difference between the groups. The baseline and 2-year total cost of restorations using RSC was lower when compared to EF (incremental cost: US$ 6.18). CONCLUSION: After two years of follow-up, Riva Self Cure shows comparable restoration survival rates to Equia Forte, being more cost-effective in the Brazilian perspective. TRIAL REGISTRATION: This randomized clinical trial was registered on ClinicalTrials.Gov - NCT02730000.

Stainless steel crown vs bulk fill composites for the restoration of primary molars post-pulpectomy: 1-year survival and acceptance results of a randomized clinical trial.

BACKGROUND: A key factor for the success and longevity of the endodontic treatment is sealing of the cavity after restorative treatment. AIM: The aim of this randomised clinical trial was to evaluate the 1-year survival of endodontic treatment in primary molars restored with stainless steel crowns (SSCs) and bulk fill composite resin (BF). As a secondary outcome, the acceptance of both children and parents was evaluated. DESIGN: Ninety-one 3- to 8-year-old children with at least one primary molar requiring endodontic treatment were selected. Participants were randomized to SSC or BF and evaluated after 1, 3, 6, and 12 months. An acceptance questionnaire was completed immediately after the treatment. The primary outcome was the endodontic treatment success, evaluated in the intention-to-treat (ITT) population using the Kaplan-Meier and non-inferiority Cox regression analyses, with a non-inferiority limit of 15%. Sensitivity analysis between the success rates after 1 year was performed using Miettinen-Nurminen's method. The Mann-Whitney test was used to compare the treatment acceptance (α = 5%). RESULTS: The survival rate after 1 year was BF = 75% and SSC = 88% (HR = 1.41; 90% CI 0.57-3.43). ITT analysis showed a success rate of BF = 86.7% and SSC = 82.6% (RR = 0.95; 0.78-1.16). The non-inferiority hypothesis between the survival of endodontic treatment could not be proved in both analyses (P > .05). The overall acceptance scores did not differ between the restorative groups (P > .05). CONCLUSION: This study failed to show non-inferiority of BF compared with the SSC. The materials were well accepted by both children and their parents.

Nonrestorative treatment of initial caries lesion in primary teeth: a systematic review and network meta-analysis.

OBJECTIVE: To identify the best available approach to avoid initial caries lesions progression in primary teeth. MATERIALS AND METHODS: Search was performed in MEDLINE/Pubmed, Web of Science, Embase and CENTRAL databases until March 2021. Studies compared treatment options to avoid the initial caries lesion progression with at least 12 months of follow-up were included. Network meta-analyses were conducted considering the non-progression of caries lesions as an outcome. RESULTS: Potentially eligible studies were screened (n = 2820) and eleven were included. Six studies evaluated the use of fluoride varnish, resin infiltration, sealing, and toothbrushing/flossing on proximal initial caries lesions. When considering occlusal surfaces, only two studies evaluating the ozone gas, fluoride varnish, resin infiltration, and sealants were included. For buccal/lingual surfaces, three studies evaluating toothbrushing, CPP-ACP paste, fluoride varnish, and resin infiltration were included. For all types of surfaces, the resin infiltration showed the best probability to avoid the progression of initial caries lesions. CONCLUSION: The limited number of included studies, most with a high risk of bias and lack of hard outcomes, such as frank cavitation, makes it not feasible to recommend a specific management approach for initial caries lesion control in primary teeth with a high certainty of evidence. PROSPERO: #CRD42016037781.

Atraumatic restorative treatment compared to the Hall Technique for occluso-proximal carious lesions in primary molars; 36-month follow-up of a randomised control trial in a school setting.

BACKGROUND: Atraumatic Restorative Treatment (ART) and the Hall Technique (HT) are both minimally invasive, non-aerosol generating procedures (non-AGPs). They seem to have never been directly compared, nor has the HT been studied in a non-clinical setting. This study compared the HT and ART restorations placed in a school setting after 36 months. METHODS: Children (5-10 yo) who had a primary molar with a dentinal occluso-proximal, cavitated carious lesion were allocated to the ART (selective removal) or HT arms. PRIMARY OUTCOME: restoration survival over 36-months (using Kaplan-Meier survival analysis, log rank test, and Cox regression). SECONDARY OUTCOMES: (1) occlusal vertical dimension (OVD) (1, 2, 3, 4 weeks) and (2) child self-reported discomfort; (3) treatment acceptability (immediately following interventions); (4) Child Oral Health Related Quality of Life (OHRQoL), before treatment and after 6 months and (5) a post hoc analysis of time to tooth exfoliation (1, 6, 12, 18, 24, 30, 36 months). RESULTS: One-hundred and thirty-one children (ART = 65; HT = 66) were included (mean age = 8.1 ± 1.2). At 36 months, 112 (85.5%) children were followed-up. PRIMARY OUTCOME: restoration survival rates ART = 32.7% (SE = 0.08; 95% CI 0.17-0.47); HT = 93.4% (0.05; 0.72-0.99), p < 0.001; Secondary outcomes: (1) OVD returned to pre-treatment state within 4 weeks; (2) treatment discomfort was higher for the HT (p = 0.018); (3) over 70% of children and parents showed a high acceptability for treatments, with crown aesthetics being a concern for around 23% of parents; (4) Child OHRQoL improved after 6 months; and (5) teeth treated with the HT exfoliated earlier than those in the ART group (p = 0.007). CONCLUSIONS: Both ART and the HT were acceptable to child participants and their parents and all parents thought both restorations protected their child's tooth. However, the crown appearance concerned almost a quarter of parents in the HT arm. Children experienced less discomfort in the ART group. Although both treatments can be performed in a non-clinical setting and have the advantage of being non-aerosol generating procedures (non-AGPs), the HT had almost three times higher survival rates (93.4%) for restoring primary molar occluso-proximal cavities compared to ART (32.7%). TRIAL REGISTRATION: This trial was registered in ClinicalTrials.gov (NCT02569047), 5th October 2015. https://clinicaltrials.gov/ct2/show/study/NCT02569047?cond=Hall+Technique+Atraumatic+Rest orative+Treatment&draw=2&rank=2.

A road map for designing and reporting clinical trials in paediatric dentistry.

BACKGROUND: Unless clinical trials are well-designed, there is a risk that they will not be usable to improve patient care. AIM: This paper discusses some factors important in designing clinical trials in paediatric dentistry. It uses the prevention and management of dental caries in children as the lens through which to look at these. FINDINGS: Amongst the factors to consider are clear research questions and objectives; appropriate outcomes and outcome measures; sample size calculation and the level of randomisation; methods for random allocation; and operator/assessor training. Experts in trial design including statisticians and a trialist should be consulted early in the design process. The aspects of trial design unique to cariology trials such as 'clustering' of data items, mixed dentition issues and those related to trials involving children (communication, consent etc) should be considered. Comprehensive reporting of trial results is essential. CONCLUSION: There are many readily available resources and tools to help the researcher design a trial of good quality that will yield results useful to the research community and beyond, to those who will implement the findings and ultimately those who will benefit from them.

Coronavirus disease (COVID-19): Characteristics in children and considerations for dentists providing their care.

The emergence of the novel virus severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causing coronavirus disease (COVID-19) has led to a global pandemic and one of the most significant challenges to the healthcare profession. Dental practices are focal points for cross-infection, and care must be taken to minimise the risk of infection to, from, or between dental care professionals and patients. The COVID-19 epidemiological and clinical characteristics are still being collated but children's symptoms seem to be milder than those that adults experience. It is unknown whether certain groups, for example children with comorbidities, might be at a higher risk of more severe illness. Emerging data on disease spread in children, affected by COVID-19, have not been presented in detail. The purpose of this article was to report current data on the paediatric population affected with COVID-19 and highlight considerations for dentists providing care for children during this pandemic. All members of the dental team have a professional responsibility to keep themselves informed of current guidance and be vigilant in updating themselves as recommendations are changing so quickly.

A Hall Technique (HT) como estratégia de manejo de lesões de cárie em molares decíduos: um estudo de coorte relacionado à esfoliação precoce e 36 meses de um ECR comparado com o Tratamento Restaurador Atr / The Hall Technique as caries management approach for primary molars: a cohort study related to early exfoliation and 36 months RCT compared to Atraumatic Restorative Treatment

O objetivo desta tese foi avaliar e comparar evidências científicas quanto à eficácia da Hall Technique (HT) comparada ao Tratamento Restaurador Atraumático (ART) para manejo de lesões de cárie de molares decíduos aplicados em campo (ambiente escolar). Este volume apresenta um compilado de um estudo de coorte retrospectivo, onde é avaliada a associação entre a HT e a esfoliação de molares decíduos, e um ensaio clínico randomizado, que compara a eficácia de dois tratamentos restauradores (ART e HT), desfechos reportados pelo paciente e a custo-eficácia do tratamento experimental (HT) quando aplicado em campo, seguindo as recomendações STROBE, CONSORT, CONSORT-PRO e CHEERS respectivamente. O estudo de coorte retrospectivo investigou a associação da utilização da HT para restaurar molares decíduos com possível esfoliação precoce. Crianças que apresentavam molares decíduos restaurados com coroas de aço através da HT e possuíam o dente contralateral presente em boca estando este hígido, restaurado com outro material/técnica que não fosse a HT, cariado ou selado foram incluídas e tiveram radiografias e registros clínicos acessados para avaliar o tempo de esfoliação. Um ensaio clínico randomizado (ECR) de superioridade foi delineado e conduzido, apresentando como desfecho primário a sobrevida de restaurações ocluso-proximais de molares decíduos tratados pelo ART e pela HT em ambiente escolar, sem nenhum tipo de facilidade odontológica após 3 anos de acompanhamento. Este ensaio clínico teve como desfechos secundários a resolução da dimensão vertical de oclusão (DVO) após a cimentação das coroas de aço pela HT; a esfoliação dos dentes tratados no estudo; o desconforto relatado pelo paciente no momento em que as restaurações foram realizadas; a aceitabilidade dos tratamentos pelos pacientes e seus responsáveis; percepção das crianças em relação à qualidade de vida relacionada à saúde bucal (QVRSB) e a custo-eficácia dos tratamentos. Os pacientes incluídos no ECR foram tratados por 3 diferentes operadores, sendo eles dois estudantes de graduação em Odontologia e um especialista em Odontopediatria, dentro das escolas municipais da cidade de Tietê, São Paulo. Os tratamentos foram avaliados em 1, 2, 3 semanas e 1, 6, 12, 18, 24, 30 e 36 meses. Foram classificadas em "sucesso", "falhas menores" e "falhas maiores". Imediatamente após os tratamentos terem sido realizados, o desconforto das crianças foi acessado por meio da escala facial de dor de Wong-Baker (WBFS). A aceitabilidade dos tratamentos foi avaliada através de questionários para as crianças e seus pais/responsáveis após a realização dos tratamentos. Em relação à QVRSB, questionários foram aplicados para as crianças previamente e seis meses após os tratamentos. O custo dos tratamentos (profissional e material) foram calculados para estimar o custo incremental dos tratamentos. Para análise estatística, foram utilizados os seguintes testes estatísticos: análise de sobrevida de Kaplan-Meier, Regressão de Cox, Regressão Linear de Multinível, Regressão Logística Ordinal, testes de Wilcoxon e Mann-Whitney, Regressão linear de Bootstrap e análises descritivas. Os níveis de significância foram ajustados em 5%. Nenhuma associação foi encontrada entre a utilização da HT em molares decíduos e a esfoliação precoce desses dentes quando comparados com seus contralaterais. A HT apresenta maior sobrevida quando comparada ao ART para manejo de lesões ocluso-proximais (HT=93,4%; ART 32,7%) e, embora tenha apresentado um maior desconforto quando comparado com o ART, esse não parece ser clinicamente relevante. A aceitação em relação aos tratamentos pelos pacientes e seus responsáveis é alta, com exceção da aparência da HT para os responsáveis. A HT se apresenta como tratamento custo-eficaz após 3 anos de acompanhamento.

Resin Infiltration May Reduce Proximal Carious Lesion Progression in Permanent Teeth With Ongoing Uncertainty for Primary Teeth.

QUESTION: Is resin infiltration effective at arresting the progression of proximal caries lesions? ARTICLE TITLE AND BIBLIOGRAPHIC INFORMATION: The effect of resin infiltration on proximal caries lesions in primary and permanent teeth. A systematic review and meta-analysis of clinical trials. Chatzimarkou S, Koletsi D, Kavvadia K. J Dent 2018; 77:8-17. SOURCE OF FUNDING: None. TYPE OF STUDY: Systematic review and meta-analysis.

Dental caries experience, care index and restorative index in children with learning disabilities and children without learning disabilities; a systematic review and meta-analysis.

BACKGROUND: Children with learning disabilities (CLD) have worse health outcomes than children with no learning disabilities (CNLD). This systematic review compared caries experience and met dental care need for CLD to CNLD using Decayed, Missing, Filled Permanent Teeth (DMFT) and decayed, missing/extracted, filled primary teeth (dmft/deft), care index (CI), and restorative index (RI) values. METHODS: Without date or language restrictions four databases were searched for; cross-sectional studies comparing caries experience and CI/ RI in CLD matched to groups of CNLD. Screening and data extraction were carried out independently and in duplicate. Risk of bias was assessed using the Newcastle-Ottawa Scale. Meta-analyses were carried out (random effects model). RESULTS: There were 25 articles with 3976 children (1 to 18 years old), from 18 countries, fitting the inclusion criteria. Children with; Down syndrome were investigated in 11 studies, autism in 8 and mixed learning disabilities in 6. The overall mean DMFT for CLD was 2.31 (standard deviation±1.97; range 0.22 to 7.2) and for CNLD was 2.51 (±2.14; 0.37 to 4.76). Using standardised mean difference (SMD), meta-analysis showed no evidence of a difference between CLD and CNLD (n = 16 studies) for caries experience (SMD = -0.43; 95%CI = -0.91 to 0.05). This was similar for sub-groups of children with autism (SMD = -0.28; 95%CI = 1.31 to 0.75) and mixed disabilities (SMD = 0.26; 95%CI = -0.94 to 1.47). However, for children with Down syndrome, caries experience was lower for CLD than CNLD (SMD = -0.73; 95%CI = -1.28 to - 0.18). For primary teeth, mean dmft/deft was 2.24 for CLD and 2.48 for CNLD (n = 8 studies). Meta-analyses showed no evidence of a difference between CLD and CNLD for caries experience across all disability groups (SMD = 0.41; 95% CI = -0.14 to 0.96), or in sub-groups: Down syndrome (SMD = 0.55; 95%CI- = - 0.40 to 1.52), autism (SMD = 0.43; 95%CI = -0.53 to 2.39) and mixed disabilities (SMD = -0.10; 95%CI = -0.34 to 0.14). The studies' risk of bias were medium to high. CONCLUSION: There was no evidence of a difference in caries levels in primary or permanent dentitions for CLD and CNLD. This was similar for learning disability sub-groups, except for Down syndrome where dental caries levels in permanent teeth was lower. Data on met need for dental caries was inconclusive. TRIAL REGISTRATION: The protocol was published in PROSPERO: CRD42017068964 (June 8th, 2017).

Low-cost GICs reduce survival rate in occlusal ART restorations in primary molars after one year: A RCT.

INTRODUCTION: The high costs of the worldwide recommended GICs might be a barrier for the implementation of ART. To overcome this problem, low cost GIC are used even though there is a lack of evidence for the survival rate of restorations. OBJECTIVES: To evaluate the performance of low-cost GICs used on occlusal ART restorations after one year. METHODS: A total of 150 primary molars in 150 children with occlusal caries lesions were selected in 4-8 year-old children. The patients were randomly allocated in three groups: G1-GC Gold Label 9 (GC Corp); G2-Vitro Molar (DFL) and G3-Maxxion R (FGM). All treatments were performed following the ART premises in school setting. Restorations were evaluated after 2, 6 and 12 months. Restoration survival was evaluated using Kaplan-Meier survival analysis and Log-rank test and Cox regression was used for testing association with clinical factors (α=5%). RESULTS: GC Gold Label 9 had better performance compared to the low-cost GICs (HR=1.47, CI=1.04-2.08, p=0.027). The overall SR of restorations was 65.33% and the SR per group was G1=77.55%; G2=61.11% and G3=42.55%. CONCLUSIONS: The low-cost GICs have a poorer performance than GC Gold Label 9 in occlusal ART restoration in primary molars.

Atraumatic Restorative Treatment compared to the Hall Technique for occluso-proximal cavities in primary molars: study protocol for a randomized controlled trial.

BACKGROUND: In many parts of the world, school-age children have high dental treatment needs; however, there is often low, or no, dental care provision. Although Atraumatic Restorative Treatment (ART) was developed to address this, its survival rate in occluso-proximal lesions is low. An alternative, the Hall Technique (HT) has shown better relative outcomes for occluso-proximal lesions, but has not been directly compared to ART or tested in field settings. This trial will compare ART and the HT for the most clinically- and cost-effective strategy for managing occluso-proximal lesions in primary molars, in a school setting, using low-technology and child-friendly dental techniques. METHODS/DESIGN: This two-arm, parallel group, patient-randomized controlled, superiority trial will have treatment provided in schools. Schoolchildren (n = 124, age 6-8) with at least one occluso-proximal carious primary molar lesion will have random allocation to treatment with ART or HT. Baseline measures and outcome data will be assessed through participant report, clinical examination and parent report/questionnaires. The primary outcome is survival rate, a composite measure of absence of Minor Failures (a defect in the restoration/crown, but not interfering with tooth health) and Major Failures (signs or symptoms of irreversible pulp damage, such as dental fistula/abscess, tooth fracture or failures that cannot be repaired). Secondary outcomes are: (1) child-reported discomfort, (2) childrens' and (3) parents' concerns around dental appearance and (4) acceptability of treatments, (5) occlusal-vertical dimensions (OVD) changes, (6) plaque index, (7) gingival health, (8) decayed, missing, filled teeth in permanent teeth (DMFT)/decayed, missing, filled teeth in primary teeth (dmft), (9) oral health-related-quality of life, reported by children and parents/caregivers, (10) the incremental cost-effectiveness, and (11) operator effect. A trained and calibrated examiner will evaluate the treated teeth after 1 week, then 1, 6, 12, 24 and 36 months post treatment. Kaplan-Meier and Cox regression tests will be used to investigate the primary outcome. The Mann-Whitney or t test, Friedman test, paired t test or Wilcoxon test and Ordinal Logistic Regression Analysis will be used to analyze the secondary outcomes. DISCUSSION: The results of this trial will support decision-making by clinicians and policy-makers for managing occluso-proximal lesions in settings with constrained resources and limited dental access. TRIAL REGISTRATION: www.clinicaltrials.gov, NCT02569047 , registered 5 October 2015.