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

ABSTRACT: 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.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.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.www.clinicaltrials.gov, NCT02569047 , registered 5 October 2015.

SUBMITTER: Hesse D

PROVIDER: S-EPMC4815168 | biostudies-literature | 2016 Mar

REPOSITORIES: biostudies-literature

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

Hesse Daniela D de Araujo Mariana Pinheiro MP Olegário Isabel Cristina IC Innes Nicola N Raggio Daniela Prócida DP Bonifácio Clarissa Calil CC

Trials 20160331

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

PMID: 27029801

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Project description:BackgroundAtraumatic 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.MethodsChildren (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 outcomerestoration 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).ResultsOne-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 outcomerestoration 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).ConclusionsBoth 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 registrationThis 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.

Project description:Introduction:Hall technique (HT) is a biological approach where decay is sealed under preformed metal crowns without any caries removal, tooth preparation or local anesthesia. Dental caries is one of the most common prevailing chronic condition that affect both adults and children. Since children are anxious and apprehensive to dental treatment, their uncooperative behavior might cause hindrance in the treatment, which often leads to manage them in general anesthesia. To better address the dental care needs in pediatric patients, dental surgeons require some alternatives for management of caries and restorative treatment in children. The Hall technique is one such conservative treatment approach developed by Dr Norna Hall in 1980s. Aim:The purpose of this study was to assess the clinical effectiveness and patient acceptance of Hall technique for managing carious primary molars. Materials and methods:84 children in the age group 6-10 years with class I and class II carious lesions limited to dentin were selected for the study. Occlusal vertical dimension (OVD) was measured preoperatively, postoperatively and after 6 months. Discomfort level was assessed by facial pain rating scale and by questionnaires filled on the day of placement of SS crown, 1 week after placement and 6 months after placement. Results:The Hall technique was found to be successful, as there was no failure clinically as well as radiographically within 6 months of placement of SS crown. The increased OVD postoperatively returned to its normal values within 6 months, the mean change in the OVD was found to be statistically significant (p = 0.02). Conclusion:The Hall technique proved to be clinically effective and acceptable by maximum number of children. How to cite this article:Bhatia HP, Khari PM, Sood S, et al. Evaluation of Clinical Effectiveness and Patient Acceptance of Hall Technique for Managing Carious Primary Molars: An In Vivo Study. Int J Clin Pediatr Dent 2019;12(6):548-552.

Project description: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.

Project description:BackgroundRemoving plaque with toothbrush and toothpaste from proximal cavities in primary molars without restoring them follows sound cariological principles. But does this treatment affect space for and alignment of their permanent successors negatively?HypothesisThere is no difference in impaction and displacement of the premolars, as well as in the D+E space in quadrants with three different statuses of the proximal surface of primary molars over a 4-year period.MethodsA total of 936 quadrants (466 maxillary and 470 mandibular quadrants) in 233 children were assessed. Treatment of cavities in the proximal surfaces of the primary molars consisted of amalgam and ART restorations using high-viscosity glass-ionomer cement, and cleaning of open large- and medium-sized cavities with toothbrush and toothpaste (UCT) under supervision for 220 days per year over 3 years. Dental casts were made at baseline, and after two, three, and 4 years. The D+E spaces were measured digitally. Status of the proximal surface of the primary molars was assessed by two calibrated examiners, and quadrants were grouped into normal anatomy, defective restoration, and proximal cavity. ANCOVA, ANOVA and LSD tests were applied.ResultsThere was a statistically significant difference between groups (p <= 0.001) and between evaluation times (p < 0.001), for the D+E space in both the maxilla and mandible. A sex difference related to the D+E space in the maxilla was found (p = 0.007). For boys, quadrants in the maxilla of the group 'proximal cavity' showed a significant shorter D+E space when compared to quadrants of the group 'normal anatomy' at the 3- and 4-year evaluation time. For girls the difference between the two groups was only present at the 3-year evaluation time. There was no significant difference between the D+E space in quadrants with defective restorations and those with normal anatomy in the mandible and in the maxilla. Displacement and impaction of the premolars showed no significant difference between groups.ConclusionPrimary molars with open proximal cavities that are cleaned with toothbrush and toothpaste do not result in displacement and impaction of the successor teeth, neither do primary molars with defective restorations in proximal tooth surfaces.

Dataset Information

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

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

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