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Aim: The aim of this randomized clinical trial was to compare the impact of two management options for primary molars with pulp necrosis (pulpectomy or extraction) on children's oral health-related quality of life (OHRQoL)., Design: A total of 100 children aged 3-5 years with at least one necrotic primary molar were selected and randomized into the study groups. The Brazilian version of early childhood oral health impact scale (B-ECOHIS) was completed by the parent proxy reports at baseline and after 4, 8 and 12 months. Differences between the trial groups were assessed through bootstrap linear regression for B-ECOHIS scores, logistic regression for dental pain self-reports and anxiety scores (α = 5%)., Results: The mean (SD) B-ECOHIS scores at baseline and after 12 months were 17.7 (6.5) and 3.0 (4.0) in the pulpectomy group and 18.8 (7.7) and 7.9 (7.7) in the extraction group. Both treatments significantly improved OHRQoL, but tooth extraction group showed higher scores in total B-ECOHIS (p < .001) and most domains, indicating lower OHRQoL. Furthermore, higher anxiety levels were reported for dental extraction compared to pulpectomy (OR = 2.52; p = .008)., Conclusion: Pulpectomy resulted in an improved OHRQoL scores after 12 months when compared to tooth extraction and should be considered as the treatment of choice for necrotic primary molars., (© 2023 The Authors. Community Dentistry and Oral Epidemiology published by John Wiley & Sons Ltd.)

Background: This non-inferiority randomised clinical trial aimed to evaluate the survival of direct bulk fill composite resin restorations in primary molars using different methods of moisture control: rubber dam isolation (RDI-local anaesthesia and rubber dam) and cotton roll isolation (CRI-cotton roll and saliva ejector). Secondary outcomes included baseline and 2-year incremental cost, self-reported child's pain scores and patient behaviour during the restorative procedure., Methods: A total of 174 molars (93 children) with dentine caries lesions were randomly allocated to study groups (RDI or CRI) and restored with bulk fill composite resin by trained operators. Two blinded examiners assessed the restorations for up to 24 months. Wong-baker faces and Frankl's behaviour rating scales were used for accessing the child's pain and behaviour, respectively. The primary outcome (restoration survival) was analysed using the two-sample non-inferiority test for survival data using Cox Regression (non-inferiority/alternative hypothesis HR > 0.85; CI = 90%). Bootstrap Linear regression was used for cost analysis and logistic regression for pain and behaviour analysis (α = 5%)., Results: After 2-years, 157 restorations were evaluated (drop-out = 9.7%). The survival rate was RDI = 60.4% and CRI = 54.3%. The non-inferiority hypothesis was accepted by the Cox Regression analysis (HR = 1.33; 90% CI 0.88-1.99; p = 0.036). RDI was 53% more expensive when compared to the CRI group. No differences were found between the groups regarding pain (p = 0.073) and behaviour (p = 0.788)., Conclusion: Cotton roll isolation proved to be non-inferior when compared to rubber dam for composite restorations longevity in primary molars. Furthermore, the latest presented the disadvantage of higher cost and longer procedure time. Clinical Significance The moisture control method does not influence the longevity of composite restorations in primary molars. Cotton roll isolation proved to be non-inferior to rubber dam isolation and is a viable option for restoring primary molars. Clinical trial registration registered NCT03733522 on 07/11/2018. The present trial was nested within another clinical trial, the CARies DEtection in Children (CARDEC-03-NCT03520309)., (© 2022. The Author(s).)

Background: Occlusoproximal restorations of primary molars usually fail, so it is necessary to investigate new materials that may overcome this challenge. Thus, this trial aimed to evaluate the longevity of occlusoproximal ART restorations in primary molars using a glass ionomer cement - GIC (Equia Forte ® - GC Corp) and a Giomer resin composite - GCR (Beautifil Bulk Restorative ® - Shofu Inc) after 24 months., Methods: One hundred and eighty-two (182) children aged from 4 to 8 years were selected and randomly assigned to GIC or GCR. A paediatric dentist treated them in the school setting in Cerquilho, Brazil, and the restorations were assessed after 3, 6, 12, 18 and 24 months. The primary outcome was the restoration survival, evaluated using the Kaplan-Meier and superiority Cox regression analyses. Intention to treat (ITT) was performed as a sensitivity analysis using superiority test P value and confidence interval (CI = 95%). Independent variables included gender, age, molar, jaw, cavity volume and caries experience., Results: The restoration survival after 24 months was GIC = 58.1% and GCR = 49.1% (HR = 1.24; CI = 0.97-1.59). ITT analysis showed a success of GIC = 61.1% and GCR = 52.2% (RR = 1.17; CI = 0.91-1.52). The superiority hypothesis was not proved in both analyses (P > 0.05)., Conclusion: GCR does not have superior longevity than GIC in occlusoproximal ART restorations of primary molars., (© 2021 Australian Dental Association.)

Background: Glass ionomer cements (GIC) have been considered the top option to restore primary teeth by dentists. The most common supply forms are hand mixed and encapsulated GIC. There is a lack of information about the impact of different GIC supply forms on restoration survival., Methods: This randomized clinical trial compared the survival rate of occlusal and occlusoproximal restorations in primary molars using two glass ionomer cements versions: hand-mixed (H/M) and encapsulated (ENC) after 24 months. Children aged 3-10 years who presented dentin caries lesions in primary molars were selected at School of Dentistry, University of São Paulo, Brazil. They were randomly assigned to groups: H /M (Fuji IX ® , GC Europe) or ENC (Equia Fill ® , GC Europe). The occurrence of restoration failure was evaluated by two blinded and calibrated examiners. The analyses were performed in Stata 13 (StataCorp, USA). To evaluate the primary outcome (restoration survival), we  performed a survival analysis. Additionally an intention to treat (ITT) analysis were done at 24 months of follow-up. Cox Regression with shared frailty was performed to assess association between restoration failure and independent variables (α = 5%)., Results: A total of 324 restorations were performed in 145 children. The survival for H/M group was 58.2% and 60.1% for ENC, with no difference (p = 0.738). Occlusoproximal restorations had lower survival rate when compared to occlusal ones (HR = 3.83; p < 0.001)., Conclusions: The survival rate in primary molars is not influenced by the different supply forms of GIC. Also, occlusoproximal restorations present reduced performances when compared to occlusal cavities., Trial Registration: This randomized clinical trial was registered on ClinicalTrials.Gov on 10/15/2014 under protocol (NCT02274142)., (© 2021. The Author(s).)

The aim of this multicenter randomized clinical trial was to evaluate the pulp vitality and survival rate of adhesive restorations performed on posterior deciduous teeth after non-selective (NSCR) or selective (SCR) carious tissue removal over 33 months. One hundred and seven children (average age 4-8 years, SD 1.4) with at least two active moderate cavitated lesions in dentin were included. Teeth were randomized and submitted to NSCR or SCR before composite resin restoration. Restorations were clinically and radiographically assessed at baseline, 6, 12, 18, 24, and 33 months by a blinded, trained, and calibrated operator in each center. The characteristics of the restorations were recorded according to FDI criteria and were considered as restorative failures when scores 4 or 5 were presented. Pulp vitality was measured by clinical and radiographic examinations, and those teeth that presented any signs or symptoms of irreversible pulpitis or pulp necrosis were considered as failure. Data were analyzed by a Cox regression model with shared frailty, considering two outcomes: pulp and restorative. A total of 278 restorations (137 after NSCR and 141 after SCR) were performed at baseline in four different centers and there was no loss in the follow-up period. Survival rate was 97.1 and 87.1% for pulp and for restorative outcome, respectively. The overall annual failure rate was 7%. There were no differences in the failure risk according to the treatment group, center, and all the clinical and demographic variables, regardless of outcome. Composite restorations of active moderate deep carious lesions performed on posterior primary teeth show satisfactory survival for restorative and pulp outcome after a 33-month follow-up, regardless of the technique executed for carious tissue removal., (© 2020 S. Karger AG, Basel.)

To evaluate the preventive effect of glass ionomer cement (GIC) against dental caries and posteruptive breakdown (PEB) on molars affected by molar incisor hypomineralization (MIH). In this randomized clinical trial, 77 children aged 5-9 years with at least 1 MIH-affected molar and without PEB or dentin caries lesions (n = 228) were included and randomly allocated to one of the following groups: (1) MIH-affected molars that remained unsealed and (2) MIH-affected molars that received GIC sealants. Dental caries and PEB were clinically evaluated after 6 and 12 months. Associations between dental caries and PEB with independent variables were evaluated using logistic regression analysis (p < 0.05). The MIH-affected molars allocated to the GIC sealant group were less likely to develop dental caries compared to those allocated to the unsealed group (OR = 0.23; 95% CI 0.06-0.95). Conversely, application of a GIC sealant was not associated with prevention of PEB (p = 0.313). Furthermore, MIH-affected molars presenting yellow-brown opacities were almost 5 times more likely to develop dental caries (p = 0.013) and PEB (p = 0.001) compared to those presenting white-creamy opacities. We can conclude that GIC sealants can prevent dental caries on MIH-affected molars; however, the same protective effect was not observed for PEB., (© 2021 The Author(s) Published by S. Karger AG, Basel.)

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.

Objective: To evaluate the 2-year survival rate and the cost-effectiveness of Atraumatic Restorative Treatment (ART) using three different glass ionomer cements (GICs) for restoring occlusal dentin caries lesions in primary molars., Methods: One hundred and fifty (150) 4-8-year-old children were selected, randomly allocated and treated in school tables according to the restorative material: Fuji IX Gold Label (GC Corp), Vitro Molar (nova DFL) and Maxxion R (FGM), the latter two being low-cost brands. Materials and professionals' costs were considered to analyse baseline total cost, and from this the cumulative cost of each treatment was calculated. Restoration assessments were performed after 2, 6, 12 and 24 months by an independent calibrated examiner. Restoration survival was estimated using Kaplan-Meier survival analysis and Cox regression was used to test association with clinical factors. Bootstrap regression (1,000 replications) compared material´s cost over time and Monte-Carlo simulation was used to build cost-effectiveness scatter plots., Results: The overall survival rate of occlusal ART restorations after 2 years was 53% (Fuji IX = 72.7%; Vitro Molar = 46.5%; Maxxion R = 39.6%). Restorations performed with Vitro Molar and Maxxion R were more likely to fail when compared to Fuji IX. At baseline, Fuji IX was the more expensive option (p < 0.001), however, considering the simulation of accumulated cost caused by failures until 2-year evaluation, no difference was found between the groups., Conclusions: After 2 years' follow up, restorations performed with Fuji IX proved to be superior in terms of survival, with a similar overall cost, when compared to low-cost glass ionomers cements (Vitro Molar and Maxxion R)., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Objective: To evaluate the survival of atraumatic restorative treatment (ART) restorations using high viscosity glass ionomer cement (GIC), compomer (COM), and glass carbomer (CAR) for occlusal and occlusoproximal cavitated dentin caries lesions in primary molars., Methods: A total of 568 4-7-year-old children (287 occlusoproximal and 281 occlusal cavities) were selected in Barueri, Brazil. The patients were randomly allocated in three groups: GIC, COM, and CAR. All treatments were performed on school setting following ART premises. Evaluations were performed after 2, 6, 12, 18, 24, and 36 months. Restoration survival was evaluated using Kaplan-Meier survival analysis and log-rank test, while Cox regression analysis was used for testing association with clinical factors (α = 5%)., Results: The overall survival rate after 3 years of occlusal ART restorations was 73% (GIC = 83%; COM = 78%; CAR = 62%) and 49% for occlusoproximal ART restorations (GIC = 56%; COM = 56%; CAR = 36%). CAR restorations were less successful than GIC and COM for both occlusal and occlusoproximal restorations (p < 0.05). No difference was found between GIC and COM (p > 0.05)., Conclusions: GIC and compomer are clinically more successful than CAR for occlusal and occlusoproximal restorations in primary molars., Clinical Significance: Both compomer and high viscosity glass ionomer cement are suitable materials for ART in primary molars. However, glass carbomer cement should not be used for ART (#NCT02217098).

Background: Since cases of deep caries lesions may result in dental extraction due to any absence of endodontic services, and considering the advantages of conservative treatment, partial caries removal can be a viable alternative to the treatment of these lesions., Case Report: During the clinical examination, generalised caries lesions were observed in a 6-year-old boy. In the maxillary right first permanent molar (tooth 16), without sensitivity to percussion and/or spontaneous pain, partial caries removal of deep caries was performed being careful to avoid pulpal exposure, followed by capping with calcium hydroxide cement and restoration using glass ionomer cement., Follow-Up: After 14 years, the success of the treatment was observed by the tooth being symptom-free, the caries arrested and healthy on periapical radiograph examination even though the restoration had been lost. Endodontic treatment was not considered necessary and the dental survival time was increased, keeping the pulp vitality and absence of apical pathologies. Therefore, a restoration with Z350 resin composite was performed to return masticatory function to the tooth., Conclusion: Partial caries removal increased the dental survival time, avoiding the necessity of endodontic treatment and early dental loss.

Introduction: Despite the widespread acceptance of conventional treatment using composite resin in primary teeth, there is limited evidence that this approach is the best option in paediatric clinics. Atraumatic restorative treatment (ART) using high-viscosity glass ionomer cement has gradually become more popular because it performs well in clinical studies, is easy to handle and is patient friendly. Therefore, the aim of this randomised clinical trial study is to compare the restoration longevity of conventional treatment using composite resin with that of ART in posterior primary teeth. As secondary outcomes, cost-efficacy and patient self-reported discomfort will also be tested., Methods and Analysis: Children aged 3-6 years presenting with at least one occlusal and/or occlusal-proximal cavity will be randomly assigned to one of two groups according to the dental treatment: ART (experimental group) or composite resin restoration (control group). The dental treatment will be performed at a dental care trailer located in an educational complex in Barueri/SP, Brazil. The unit of randomisation will be the child. A sample size of 240 teeth with occlusal cavities and 188 teeth with occlusal-proximal cavities has been calculated. The primary outcome will be restoration longevity, which will be clinically assessed after 6, 12, 18 and 24 months by two examiners. The duration of the dental treatment and the cost of all materials used will be considered when estimating the cost-efficacy of each treatment. Individual discomfort will be measured after each dental procedure using the Facial Scale of Wong-Baker., Ethics and Dissemination: This clinical trial was approved by the local ethics committee from the Faculty of Dentistry of the University of São Paulo (registration no. 1.556.018). Participants will be included after their legal guardians have signed an informed consent form containing detailed information about the research., Trial Registration Number: www.clinicaltrials.gov, NCT02562456; Pre-results., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

It is ten years since the first paper on the Hall Technique was published in the British Dental Journal and almost 20 years since the technique first came to notice. Dr Norna Hall a (now retired) general dental practitioner from the north of Scotland had, for many years, been managing carious primary molar teeth by cementing preformed metal crowns over them, with no local anaesthesia, tooth preparation or carious tissue removal. This first report, a retrospective analysis of Dr Hall's treatments, caused controversy. How could simply sealing a carious lesion, with all the associated bacteria and decayed tissues, possibly be clinically successful? Since then, growing understanding that caries is essentially a biofilm driven disease rather than an infectious disease, explains why the Hall Technique, and other 'sealing in' carious lesion techniques, are successful. The intervening ten years has seen robust evidence from several randomised control trials that are either completed or underway. These have found the Hall Technique superior to comparator treatments, with success rates (no pain or infection) of 99% (UK study) and 100% (Germany) at one year, 98% and 93% over two years (UK and Germany) and 97% over five years (UK). The Hall Technique is now regarded as one of several biological management options for carious lesions in primary molars. This paper covers commonly asked questions about the Hall Technique and speculates on what lies ahead.

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., (Copyright © 2016. Published by Elsevier Ltd.)

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.