Dataset Information

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.

ABSTRACT:

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.

SUBMITTER: Araujo MP

PROVIDER: S-EPMC7656501 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundIn 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/designThis 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.DiscussionThe 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 registrationwww.clinicaltrials.gov, NCT02569047 , registered 5 October 2015.

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.

Dataset Information

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

Methods

Primary outcome

Secondary outcomes

Results

Primary outcome

Conclusions

Trial registration

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