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.

Clinical experience of undergraduate dental students in paediatric dentistry: A 5-year cross-sectional study.

INTRODUCTION: The clinical experience of undergraduate dental students in Paediatric Dentistry has a profound influence on their future confidence. The purpose of this study was to evaluate the clinical experience of undergraduate students in Paediatric Dentistry over five consecutive years and to determine whether changes in teaching practices are reflected in the clinic. MATERIALS AND METHODS: In total, 196 records submitted at the end of the Paediatric Dentistry training from the last 5 years (2016-2020) were evaluated. The variables analysed included the number of patients treated per student, the year, and the numbers and types of procedures performed individually across the years. The data were grouped into two categories; pre and post implementation of an electronic portfolio and a change in teaching practices (2016-2017 and 2018-2020 respectively). Data were analysed using Student's t-test or Mann-Whitney for two group comparison, depending on data distribution (α = 5%). RESULTS: There was a significant reduction in the number of radiographs exposed (p = .013) between the two groups. The number of fissure sealants had increased in recent years (p < .001). Although the number of stainless steel crowns performed remained unchanged (p = .98), there was an increase in the number of crowns placed using the Hall technique (p < .001) and a concurrent decrease in the number of conventional crowns placed (p < .001). CONCLUSION: The clinical experience of undergraduate students has changed in line with evolving teaching practices. The use of objective measures such as patient numbers and range of procedures can be used as a method of evaluating student clinical experience. Other assessment tools are still required to evaluate additional aspects of clinical learning in paediatric dentistry.

Prevalence of hypomineralised second primary molars (HSPM): A systematic review and meta-analysis.

AIM: To evaluate the prevalence of HSPM worldwide on a child and a tooth level and investigate the influence of diagnostic criteria on the prevalence of HSPM. DESIGN: A comprehensive literature search was performed through MEDLINE/PubMed, Scopus, and Web of Science databases. The grey literature was also screened as were the reference lists of included studies. An adaptation of the Newcastle-Ottawa Scale was used to evaluate the quality of the studies. A meta-analysis was performed to determine the pooled prevalence of HSPM. RESULTS: The search strategy identified 1,988 articles, 487 were retrieved for full-text evaluation, and 37 studies were included in the meta-analysis (32 for child and 23 for tooth level prevalence), providing data from 26,805 individuals and 81,107 molars. The prevalence of HSPM was 6.8% (95% CI 4.98%-8.86%) on a child level and 4.08% on a tooth level (95% CI = 2.80%-5.59%). The diagnostic criteria used did not seem to influence the prevalence results (P > .05). The majority of the papers (75%) showed a low-to-moderate risk of bias. CONCLUSION: There was a broad variation in the prevalence reported that may be attributed to differences in the study population. The present meta-analysis showed a HSPM prevalence worldwide of 6.8% on a child level and 4.1% on a tooth level.

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.

Pulp Vitality and Longevity of Adhesive Restorations Are Not Affected by Selective Carious Removal: A Multicenter Clinical Trial.

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.

Survival rate of primary molar restorations is not influenced by hand mixed or encapsulated GIC: 24 months RCT.

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).

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.

Glass carbomer and compomer for ART restorations: 3-year results of a randomized clinical trial.

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).

Effectiveness of conventional treatment using bulk-fill composite resin versus Atraumatic Restorative Treatments in primary and permanent dentition: a pragmatic randomized clinical trial.

BACKGROUND: Clinical studies are being conducted in less strict conditions in order to establish an adequate scientific basis for decision making. The aim of this pragmatic randomized clinical trial is to evaluate the effectiveness of single and multiple-surfaces restorations performed following the Atraumatic Restorative Treatment (ART) premises compared with Conventional Treatment (CT) using bulk fill composite restorations in primary and permanent teeth. METHODS/DESIGN: A total of 1,214 5-to-13 year-old children with at least one single or multiple-surface dentin caries lesion in primary or permanent molars will be selected in public schools of Barueri-SP, Brazil. The participants will be randomly assigned into 2 groups: CT (caries removal with bur and restoration performed with Scotchbond™ Universal Adhesive system associated with Filtek Bulk Fill - 3 M/ESPE) and ART (Caries removal with hand instruments and restoration with high viscosity glass ionomer cement Ketac Molar Easy Mix - 3 M/ESPE). Ten untrained dentists will perform the treatment in in dental offices located at public schools. The restorations will be evaluated after 6, 12 and 24 months by an independent trained and calibrated examiner. The restoration and tooth survival, the cost-effectiveness analysis between the two groups and the operators' preferences regarding the techniques will be also evaluated. Kaplan-Meier survival analysis and log-rank test will be applied for the restoration and tooth survival. All the average event rates in the two groups will be modelled and compared with a Cox proportional hazard shared frailty model since there is an operator-cluster effect. The significance level for all analyses will be 5 %. DISCUSSION: Our hypothesis is that despite similar expected effectiveness between ART using high viscosity GIC and conventional treatment using bulk fill composite resin when treating single or multiple-surface in posterior primary and permanent teeth, ART will present superior cost-effectiveness. The results of this trial will support decision-making by clinicians and policy makers. TRIAL REGISTRATION: NCT02568917 . Registered on May 10th 2015.

Impact of pulpectomy versus tooth extraction in children's oral health-related quality of life: A randomized clinical trial.

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.

Sleep bruxism and associated physiological events in children with obstructive sleep apnea: a polysomnographic study.

STUDY OBJECTIVES: The aim of this study was to evaluate the physiological events associated with sleep bruxism (Sleep Bruxism [SB]; presence of mandibular movement activity) and the control window (4 minutes prior to SB event, where no mandibular movement activity was detected) in a polysomnography study in children with mild sleep apnea. METHODS: Polysomnography data from children aged 4 to 9 years old diagnosed with mild sleep apnea were analyzed by 2 trained examiners. The mandibular movement activity (bruxism event; SB) was classified into phasic and tonic. The control window was selected 4 minutes prior to the SB event. All physiological events were recorded in both bruxism and control windows, including sleep phase (N1, N2, N3, and rapid eye movement), arousal, leg movements, tachycardia, bradycardia, oxygen desaturation, and number of obstructive and central sleep apnea events. The moment in which those phenomena occurred when associated with SB was also analyzed (before/after). Data were analyzed using 95% confidence intervals (α = 5%). RESULTS: A total of 661 mandibular movements were analyzed and classified as tonic (n = 372) or phasic (n = 289). The mean apnea-hypopnea index was 1.99 (SD = 1.27) events/h. The frequency of leg movements, microarousal, and tachycardia was increased in SB events when compared with the control window (P < .05). There was an increase in bradycardia frequency in the control window when compared with SB (in both tonic and phasic events). The frequency of obstructive and central apnea during SB was lower when compared with the other physiological phenomena. CONCLUSIONS: There is a difference in the physiological parameters evaluated in children with mild sleep apnea when comparing the 2 windows (SB and control). Sleep bruxism is associated with other physiological phenomena, such as leg movements, tachycardia, and microarousal. The use of a control window (where no mandibular activity was detected) was representative since it did not show activation of the sympathetic nervous system. CITATION: Bonacina CF, Soster LMSFA, Bueno C, et al. Sleep bruxism and associated physiological events in children with obstructive sleep apnea: a polysomnographic study. J Clin Sleep Med. 2024;20(4):565-573.

COVID-19 pandemic impact on dentists in Latin America's epicenter: São-Paulo, Brazil.

The state of São Paulo, Brazil, where more than 94.000 dentists are currently registered, has become the epicenter of COVID-19 in Latin America. The aim of this cross-sectional study was to evaluate the impact of COVID-19 pandemic on dentists in this state. A semi-structured questionnaire was sent via e-mail to 93.280 dentists with active registration in the Dental Council of São Paulo (CROSP). The impact of COVID-19 pandemic was assessed through questions related to demographic, socioeconomic, dental practice characteristics and personal protective equipment (PPE) use. Ordinal logistic regression analysis was performed to investigate the association between all the variables (p<0.05). Over 8 days, 2113 responses were received. Only 26.52% of the sample reported a low-income reduction (from 0-10%), while the majority of dentists reported a more negative financial impact, 35.6% with a reduction of more than 50% of their monthly income. Dentists who worked in the private sector and at the capital had a greater financial impact when compared to those of the public sector and countryside of the state (p<0.05). Furthermore, about 83% reported not having received any specific training to control the transmission of coronavirus in the health area. This study provides evidence of the negative impact of the COVID-19 pandemic on the routine of dentists in the state of São Paulo, Brazil. Hopefully, this study will help dental and other health care professionals to better understand the consequences of disease in dental settings and strengthen preparedness throughout the dental health care system.

Is it worth using low-cost glass ionomer cements for occlusal ART restorations in primary molars? 2-year survival and cost analysis of a Randomized clinical trial.

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).

Efficacy of conventional treatment with composite resin and atraumatic restorative treatment in posterior primary teeth: study protocol for a randomised controlled trial.

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.

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.

ART restorations for occluso-proximal cavities in primary molars: a two-year survival and cost analysis of an RCT comparing two GIC brands

Abstract There are many glass ionomer cements available on the Brazilian market for Atraumatic Restorative Treatment (ART), however, there is still a gap in the literature regarding their cost-effectiveness. Objectives To evaluate the influence of restorative materials (Ketac Molar, 3M ESPE; and Vitro Molar, Nova DFL) in the two-year survival rate and cost-effectiveness of occluso-proximal ART restorations in primary molars. Methodology A total of 117 children (aged four to eight years) with at least one occluso-proximal carious lesion in primary molars were selected and randomly divided in treatment groups (KM or VM) in this parallel randomized controlled trial. Treatments followed ART premises and were conducted in public schools by trained operators in Barueri, Brazil. A trained, calibrated, and blinded examiner performed the evaluations after two, six, 12, and 24 months (k=0.92). Kaplan-Meier survival analysis was used to estimate restoration survival and Cox regression was used to test the association with clinical factors (α=5%). For cost analysis, material and professional costs were considered. Monte Carlo analysis was used to generate a cost-effectiveness plane and bootstrapping was used to compare material costs over the years. Results The overall survival rate was 36.9% after two years (48.6% for KM and 25.4% for VM). Restorations with VM failed more than those with KM (HR=1.70; 95% CI=1.06-2.73; p=0.027). VM presented lower initial cost, but no difference was observed between groups considering the two-year incremental cost. Conclusion After a two-year evaluation, KM proved to be a better option than VM for occluso-proximal ART restorations in primary molars. ClinicalTrials.gov: NCT02267720

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.

Survival rate of pulpectomy in primary teeth using Feapex® paste: a clinical study in infants / Sobrevida de pulpectomia em dentes decíduos utilizando pasta Feapex®: um estudo clínico em bebês

Objective: The aim of this clinical study was to evaluate the survival rate of a new pulpectomy protocol using 2% chlorhexidine digluconate gel and Feapex® paste for endodontic treatment in primary teeth. Material and Methods: A total of 105 pulpectomies were performed in anterior and posterior teeth of 48 infants (1-3 years old) with high caries experience with irreversible pulpitis or pulp necrosis. All treatments were performed by dental surgeons with no specialization in Pediatric Dentistry, under local anesthesia and rubberdam isolation. Manual files were used in conjunction with 2% chlorherixidine gel for root canal instrumentation, and Feapex® paste was used as a obturation material. The clinical and radiographic outcomes were collected by one trained independent evaluator with a follow-up period of 24months. Success was determined by the absence of pain, pathological mobility, pathologic bone rarefaction, pathological root resorption and soft tissue pathology around the affected tooth Survival of the endodontic treatment was evaluated by estimating survival rates through Kaplan-Meier curves. Cox Regression analysis with shared fragility were performed to evaluate the association between the independent variables to endodontic treatment failure (α=5%). Results: After 24 months, the treatment survival was 86% (SE=0.03). Root resorption at baseline was associated with a higher risk of failure (HR=2.81; CI=1.12-7.08; p=0.027). The survival rate of the endodontic treated teeth due to dental trauma was 100%, while teeth with dental caries had lower survival rate (85.05%; p<0.001*). Other variables analyzed included gender, age of the child, tooth position (incisor/molar), restoration type, obturation quality, and caries experience were not associated with treatment failure (p>0.05). Conclusion: The new protocol using 2% chlorhexidine digluconate and Feapex® presented a high survival rate and can be considered as a suitable protocol for pulpectomy in primary teeth.Trial Registration: REBEC (RBR-282s2f) (AU)

Objetivo: Avaliar a sobrevida de um novo protocolo para tratamento endodôntico (pulpectomia) em dentes decíduos utilizando gel de digluconato de clorexidina 2% e pasta Feapex®. Material e Métodos: Um total de 105 pulpectomias foram realizadas em dentes anteriores e posteriores diagnosticados com pulpite irreversível ou necrose pulpar em 48 crianças (1-3 anos de idade) com alta experiência de cárie. Todos os tratamentos foram realizados por cirurgiões-dentistas clínicos gerais, sob anestesia local e isolamento absoluto. Limas manuais foram utilizadas em conjunto com cloroherixidina 2% gel para instrumentação dos canais radiculares e pasta Feapex® foi utilizada como material de obturação. Os resultados clínicos e radiográficos foram coletados por um avaliador independente treinado com um período de acompanhamento de 24 meses. O sucesso foi determinado pela ausência de dor, mobilidade patológica, rarefação óssea patológica, reabsorção radicular patológica e ausência de fístula/abscesso ao redor do dente tratado. A sobrevida do tratamento endodôntico foi estimativa utilizando curvas de Kaplan-Meier. Análise de regressão de Cox com fragilidade compartilhada foi realizada para avaliar a associação entre as variáveis independentes com a falha do tratamento endodôntico (α = 5%). Resultados: Após 24 meses, a sobrevida do tratamento foi de 86% (EP = 0,03). A reabsorção radicular no início do estudo foi associada a um maior risco de falha (HR= 2,81; IC= 1,12-7,08; p= 0,027). Dentes tratados endodonticamente devido ao traumatismo dentário na dentição decídua apresentaram taxa de sobrevida de 100%, enquanto dentes com comprometimento pulpar devido à cárie dentária tiveram menor sobrevida (85,05%; p<0,001 *). Todas as outras variáveis analisadas como sexo, idade da criança, dente (incisivo/molar), tipo de restauração, qualidade da obturação e experiência de cárie não foram associadas à falha do tratamento (p> 0,05). Conclusão: O novo protocolo utilizando digluconato de clorexidina 2% e Feapex® apresentou alta sobrevida e pode ser considerado um protocolo adequado para pulpectomia em dentes decíduos.Registro do estudo clínico: REBEC (RBR-282s2f). (AU)

Sobrevida de resina compuesta y cemento de ionómero de vidrio de bajo costo para TRA: 1 año de seguimiento de un ensayo clínico aleatorizado / Sobrevivência da resina composta e do cimento do ionômero de vidro de baixo custo para ART: 1 ano de acompanhamento de um ensaio clínico randomizado / Survival of composite resin and low cost glass ionomer cement for ART: 1 year fo-llow-up of a randomized clinical trial

Objetivo: Evaluar la longevidad de restauraciones de Tratamiento Restaurador Atraumático (TRA), utilizando dos mate-riales diferentes: un Cemento de Ionómero de Vidrio (CIV) de bajo costo y una Resina Compuesta de nanopartículas (RC), en cavidades ocluso-proximales de molares temporales. Materiales y métodos: Un total de 83 dientes fueron selecciona-dos en 43 niños de siete a diez años de edad, que presentaron al menos una lesión de caries ocluso proximal, en la ciudad de Cosmópolis / SP, Brasil. Los pacientes fueron asignados en dos grupos: CIV de bajo costo (Vitromolar - Nova DFL) y resina compuesta de nanopartículas (RC) (Filtek Z350 XT - 3M ESPE). Todos los procedimientos se realizaron de acuerdo con los principios del TRA. Las restauraciones fueron evaluadas después de 3, 6, 9 y 12 meses por un examinador entrena-do. Para verificar la tasa de sobrevida de las restauraciones utilizamos el análisis de sobrevida de Kaplan-Meier y la prueba de Log-Rank; y, para evaluar la asociación entre el resultado y las variables del paciente se aplicó la prueba de regresión de Cox. El nivel de significancia para todas las pruebas fue del 5%. Resultados: Después de 12 meses de seguimiento, la sobrevida global de las restauraciones fue de 75,3%. Las tasas de sobrevida del CIV y de la RC fueron 62.2% y 93.7%, respectivamente. El análisis estadístico mostró diferencias significativas entre los materiales, donde la RC tuvo un mejor desempeño (HR = 0.15, IC 0.03 a 0.68, p = 0.014) que el CIV de bajo costo. No se encontraron diferencias estadísticas para otras variables (p >0.05). Conclusión: La utilización de resina compuesta de nanopartículas en las restauraciones de TRA tuvo un mejor rendimiento en comparación con el cemento de ionómero de vidrio de bajo costo, después de una evaluación de 12 meses. Registro de prueba: REBEC (Registro Brasileño de Ensayos Clínicos) # RBR-8sw24r.

Objective: To evaluate the longevity of ART restorations using two different materials: a low-cost Glass Ionomer Cement (GIC) and nanoparticle Composite Resin (CR) in occlusal-proximal cavities of primary molars. Material and methods: A total of 83 teeth were selected among 43 children, aged seven to ten years old, which presented at least one multi-sur-face caries lesion, in the city of Cosmópolis/SP, Brazil. Patients were allocated into two groups: low cost GIC (Vitromo-lar ­ Nova DFL) and nanoparticle composite resin (CR) (Filtek Z350 XT ­ 3M ESPE). All procedures were performed according to ART guidelines. The restorations were evaluated after 3, 6, 9 and 12 months by a trained examiner. To verify the survival rate of the restorations we used Kaplan-Meier survival analysis and log-rank test. To evaluate the association between the outcome and patient variables was applied Cox regression test. The significance level for all tests was 5%. Results: After 12 months of follow-up, overall survival of the restorations was 75.3%. The GIC and CR survival rates were 62.2%, 93.7%, respectively. Statistical analysis showed significant differences between materials, where the CR performed better (HR = 0.15, CI 0.03 to 0.68; p = 0.014) than low cost GIC. No statistical differences were found for other variables (p >0.05). Conclusion: The use of nanoparticle composite resin in ART restorations performed better when compared to low cost glass ionomer cement after 12 months evaluation. Trial registration: REBEC (Registro Brasileiro de Ensaios Clínicos) # RBR-8sw24r.

Avaliar a longevidade das restaurações Tratamento Restaurador Atraumático (ART) utilizando dois materiais diferentes: Cimento de Ionómero de vidro (CIV) de baixo custo e de uma Resina Composta de nanopartículas (RC), em cavidades ocluso proximais de molares decíduos. Materiais e métodos: Um total de 83 dentes foram selecionados em 43 crianças de sete a dez anos de idade que tiveram pelo menos uma lesão de cárie oclusal proximal, na cidade de Cosmópolis / SP, Brasil. Os pacientes foram distribuídos em dois grupos: CIV de baixo custo (Vitromolar - Nova DFL) e resina composta de nanopartículas (RC) (Filtek Z350 XT - 3M ESPE). Todos os procedimentos foram realizados em conformidade com os princípios do ART. As restaurações foram avaliadas após 3, 6, 9 e 12 meses, por um examinador treinado. Para verificar a taxa de sobrevivência das restaurações, usamos análise de sobrevivência de Kaplan-Meier e teste log-rank; e para avaliar a associação entre o desfecho e as variáveis do paciente testou-se pela regressão de Cox. O nível de significância para todos os testes foi de 5%. Resultados: Após 12 meses de acompanhamento, a sobrevida global das restaurações foi de 75,3%. As taxas de sobrevida de CIV e RC foram 62,2% e 93,7% respectivamente. A análise estatística mostrou diferenças significativas entre os materiais onde a RC mostrou melhores resultados (HR = 0,15, IC 0,03-0,68, p = 0,014) do que o CIV de baixo custo. Não há diferenças estatísticas para as outras variáveis (p> 0,05). Conclusão: A utilização de restaurações de resina composta de nanopartículas teve um melhor desempenho em comparação com o cimento de ionómero de vidro de baixo custo, depois de uma avaliação de 12 meses. Registro de ensaio: REBEC (Registro Brasileiro de Ensaios Clínicos) # RBR-8sw24r.

Análisis conductual de niños brasileños que participan del "Programa boquita del bebé" ­ Gurupi/Tocantins / Behavioral analysis of Brazilian children participating in the "Baby's Little Mouth Program" at Gurupi-Tocantins / Análise comportamental de crianças brasileiras participantes do "Programa Bo-quinha do Bebê" ­ Gurupi/Tocantins

La respuesta del comportamiento del niño ha sido estudiada en algunas investigaciones y es útil para predecir cómo el niño reacciona al tratamiento odontológico, especialmente los bebés y los niños más pequeños, que es donde se encuentra uno de los mayores desafíos de la odontopediatría. Objetivo: Evaluar el patrón de comportamiento de niños de 3 a 5 años de edad, en un programa preventivo de la municipalidad de Gurupi/Tocantins, Brasil. Materiales y métodos: Este estudio fue evaluado y aprobado por el comité de ética e investigación. Un total de 60 niños, con diferentes perfiles de participación del programa "boquita del bebé" fueron analizadas. Entre ellos, 20 frecuentaban el programa, 20 habían desistido y 20 nunca participaron anteriormente. El perfil de comportamiento fue analizado por un examinador externo en el momento de la higiene bucal (profilaxis) por medio de la escala de comportamiento de Venham. Los datos fueron analizados mediante la regresión de Poisson (α=5%). Resultados: Los niños que presentaron peor comportamiento fueron aquellas que nunca participaron del programa "boquita del bebé" (OR: 3.80 / p=0.008), así como, los niños que no permitían el cepillado en casa (OR: 4.17 / p=0.001) y aquellos que sólo permitían el cepillado en ocasiones (OR: 3.07 / p=0.010). Conclusión: Existe una influencia positiva del programa en el condicionamiento psicológico, en la ansiedad de los niños y en la adopción de hábitos correctos en sus rutinas diarias.

The behavioral response of the child has been studied in some researches and is useful to predict how the child reacts to dental treatment, especially infants and young children, which is one of the greatest challenges of pediatric dentistry. Ob-jective: To evaluate the behavioral pattern of children from 3 to 5 years of age in a preventive program in the municipality of Gurupi /Tocantins, Brazil. Materials and methods: This study was evaluated and approved by the Ethics and Research Committee. A total of 60 children, with different participation profiles of the program "Baby's Little Mouth" were analyzed. Of these, 20 were frequent program participants, 20 were dropouts and 20 had never participated in the program before. The behavioral profile was analyzed by an external examiner, at the time of oral hygiene (prophylaxis), through the behavioral scale of Venham. Data were analyzed using Poisson regression analysis (α = 5%). Results: The children who presented the worst behavior were those who had never participated in the "Baby's Little Mouth" program (OR=3.80; p=0.008), as well as children who did not allow brushing at home (OR=4.17; p=0.001) and those that only allowed brushing someti-mes (OR=3.07; p=0.010). Conclusion: There is a positive influence of the program on psychological conditioning, on the anxiety of children and on the adoption of correct daily habits in their routines.

A resposta comportamental da criança tem sido estudada em algumas pesquisas e sendo útil para prever como a criança reage ao tratamento odontológico, especialmente os bebês e as crianças mais novas, que é onde se encontra um dos maiores desafios da odontopediatria. Objetivo: Avaliar o padrão comportamental de crianças de 3 a 5 anos de idade, em um programa preventi-vo do município de Gurupi/Tocantins, Brasil. Materiais e métodos: Este estudo foi avaliado e aprovado pelo Comitê de ética e pesquisa. Um total de 60 crianças, com diferentes perfis de participação do programa "Boquinha do bebê" foram analisadas. Dentre elas, 20 eram frequentadoras assíduas do programa, 20 eram desistentes e 20 nunca participaram anteriormente. O perfil comportamental foi analisado por um examinador externo no momento da higienização bucal (profilaxia) por meio da escala comportamental de Venham. Os dados foram analisados mediante a Regressão de Poisson (α=5%). Resultados: As crianças que apresentaram pior comportamento foram aquelas que nunca participaram do programa "Boquinha do bebê" (OR: 3,80 / p=0,008), assim como, as crianças que não permitiram escovação em casa (OR: 4,17 / p=0,001) e aquelas que só permi-tiam a escovação às vezes (OR: 3,07 / p=0,010). Conclusão: Existe uma influência positiva do programa no condicionamento psicológico, na ansiedade das crianças e na adoção de corretos hábitos em suas rotinas.