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.

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.