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Failure rate of atraumatic restorative treatment using high-viscosity glass-ionomer cement compared to that of conventional amalgam restorative treatment in primary and permanent teeth: a systematic review update
Abstract
BACKGROUND: Atraumatic restorative treatment (ART) is a minimally invasive procedure that involves removing markedly softened carious enamel and dentine, using only hand instruments, and then restoring the resulting cavity with an adhesive restorative material. Although developed for use in the less industrialized parts of the world ART has now been accepted as part of the minimum intervention (MI) dentistry philosophy in developed countries. Currently the restorative material of choice for ART is high-viscosity glass ionomer cement (GIC). GIC is ideally suited to managing dental caries according to the principles of MI dentistry, as it can be applied in the very early stages of caries development or in the larger cavity. Additionally, it simplifies the restorative procedure and enables the dentine-pulp complex to react against the carious process.
REVIEW OBJECTIVE: This systematic review update seeks to answer the question as to whether, in patients with carious cavities of any class in primary and permanent teeth, ART restorations with high-viscosity GIC have a higher failure rate than amalgam restorations placed with conventional rotary instruments, in tooth cavities of the same size, type of dentition and follow-up period after one or more years.
SEARCH STRATEGY: The following databases were searched for relevant trials up to January 2012: MEDLINE accessed via PubMed; CENTRAL accessed via Cochrane Library; Open access sources: Biomed Central, Database of Open Access Journals (DOAJ), OpenJ-Gate; Regional databases: Bibliografia Brasileira de Odontologia (BBO), Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS), IndMed, Sabinet, Scielo; Grey-Literature sources: Scirus (Medicine), OpenSIGLE, Google Scholar. Hand searching was performed for journals not indexed in the databases. References of included studies were checked.
SELECTION CRITERIA: Prospective, clinical controlled trials, with focus relevant to review objective and reporting on computable data with a follow-up period of at least one year were selected without language restrictions.
DATA COLLECTION AND ANALYSIS: Two review authors independently screened and extracted data from, and assessed the risk of bias in, the selected trial reports. Individual datasets were extracted from the trial results and analyzed regarding in-between-dataset heterogeneity and effect size estimates. The investigated outcome was restoration failure. Meta-analysis was conducted on condition of in-between-dataset homogeneity. Internal trial validity was assessed in terms of selection-, performance-, detection-, attrition-, publication- and reporting bias. Research gaps in the precision and consistency of the results were evaluated.
MAIN RESULTS: Eighteen trials were accepted of which 10 were currently available for review. Of these 32 individual dichotomous datasets could be extracted and analyzed. The majority of the results show no differences between both types of intervention. High risk of selection-, performance-, detection- and attrition bias was established. Existing research gaps are mainly due to lack of trials and small sample size.
CONCLUSION: The current evidence indicates that the failure rate of high-viscosity GIC/ART restorations is not higher than, but similar to that of conventional amalgam fillings after periods longer than one year. These results are in line with the conclusions drawn during the original systematic review. There is a high risk that these results are affected by bias, and confirmation by further trials with suitably high number of participants is needed.
Background:
Dental caries is a sugar-dependent disease that damages tooth structure and, due to loss of mineral components, may eventually lead to cavitation. Dental caries is the most prevalent disease worldwide and is considered the most important burden of oral health. Conventional treatment methods (drill and fill) involve the use of rotary burs under local anaesthesia. The need for an electricity supply, expensive handpieces and highly trained dental health personnel may limit access to dental treatment, especially in underdeveloped regions.To overcome the limitations of conventional restorative treatment, the Atraumatic Restorative Treatment (ART) was developed, mainly for treating caries in children living in under-served areas of the world where resources and facilities such as electricity and trained manpower are limited. ART is a minimally invasive approach which involves removal of decayed tissue using hand instruments alone, usually without use of anaesthesia and electrically driven equipment, and restoration of the dental cavity with an adhesive material (glass ionomer cement (GIC), composite resins, resin-modified glass-ionomer cement (RM-GICs) and compomers).
Objectives:
To assess the effects of Atraumatic Restorative Treatment (ART) compared with conventional treatment for managing dental caries lesions in the primary and permanent teeth of children and adults.
Search methods:
Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 22 February 2017), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2017, Issue 1), MEDLINE Ovid (1946 to 22 February 2017), Embase Ovid (1980 to 22 February 2017), LILACS BIREME Virtual Health Library (Latin American and Caribbean Health Science Information database; 1982 to 22 February 2017) and BBO BIREME Virtual Health Library (Bibliografia Brasileira de Odontologia; 1986 to 22 February 2017). The US National Institutes of Health Trials Registry (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials. No restrictions were placed on the language or date of publication when searching the electronic databases.
Selection criteria:
We included randomised controlled trials (RCTs) with at least six months' follow-up that compared the effects of ART with a conventional restorative approach using the same or different restorative dental materials to treat caries lesions.
Data collection and analysis:
Two review authors independently screened search results, extracted data from included studies and assessed the risk of bias in those studies. We used standard methodological procedures expected by Cochrane to evaluate risk of bias and synthesise data. Where pooling was appropriate we conducted meta-analyses using the random-effects model. We assessed the quality of the evidence using GRADE criteria.
Main results:
We included a total of 15 eligible studies randomising 3760 participants in this review. The age of participants across the studies ranged from 3 to 101 years, with a mean of 25.42 years. 48% of participants were male. All included studies were published between 2002 and 2016. Two of the 15 studies declared that the financial support was from companies that manufacture restorative material. Five studies were individually randomised parallel-group studies; six were cluster-randomised parallel-group studies; and four were randomised studies that used a split-mouth design. Eleven studies evaluated the effects of ART on primary teeth only, and four on permanent teeth. The follow-up period of the included studies ranged from 6 months to 36 months. We judged all studies to be at high risk of bias.For the main comparison of ART compared to conventional treatment using the same material: all but two studies used high-viscosity glass ionomer (H-GIC) as the restorative material; one study used a composite material; and one study used resin-modified glass ionomer cement (RM-GIC)).Compared to conventional treatment using H-GIC, ART may increase the risk of restoration failure in the primary dentition, over a follow-up period from 12 to 24 months (OR 1.60, 95% CI 1.13 to 2.27, five studies; 643 participants analysed; low-quality evidence). Our confidence in this effect estimate is limited due to serious concerns over risk of performance and attrition bias. For this comparison, ART may reduce pain during procedure compared with conventional treatment (MD -0.65, 95% CI -1.38 to 0.07; 40 participants analysed; low-quality evidence)Comparisons of ART to conventional treatment using composite or RM-GIC were downgraded to very low quality due to indirectness, imprecision and high risk of performance and attrition bias. Given the very low quality of the evidence from single studies, we are uncertain about the restoration failure of ART compared with conventional treatment using composite over a 24-month follow-up period (OR 1.11, 95% CI 0.54 to 2.29; one study; 57 participants) and ART using RM-GIC in the permanent teeth of older adults with root caries lesions over a six-month follow-up period (OR 2.71, 95% CI 0.94 to 7.81; one study; 64 participants).No studies reported on adverse events or costs.
Authors' conclusions:
Low-quality evidence suggests that ART using H-GIC may have a higher risk of restoration failure than conventional treatment for caries lesions in primary teeth. The effects of ART using composite and RM-GIC are uncertain due to the very low quality of the evidence and we cannot rely on the findings. Most studies evaluated the effects of ART on the primary dentition.Well-designed RCTs are required that report on restoration failure at clinically meaningful time points, as well as participant-reported outcomes such as pain and discomfort. Due to the potential confounding effects from the use of different dental materials, a robust body of evidence on the effects of ART compared with conventional treatment using the same restoration material is necessary. We identified four ongoing trials that could provide further insights into this area.
Objective:
Paediatric dental care under general anaesthesia among preschool children in Western Australia is increasing and costly. This study assessed cost-effectiveness of the atraumatic restorative treatment-based (ART-based) approach against the standard care (SC) approach to managing early childhood caries in a primary care setting based on a 1-year pragmatic randomized controlled trial.
Methods:
Cost-effectiveness analysis, from the service provider perspective, was conducted. Outcomes include number of referral to specialists and dental treatments. One-way and probabilistic sensitivity analyses were undertaken to test the robustness of the cost-effectiveness estimates.
Results:
Six children in the ART-based group and 62 children in the SC group (n = 127 each group) were referred for paediatric dental specialist care. Children in the ART-based group received more dental services than those allocated to the SC group (mean = 3.8, SD 2.0 and mean = 1.8, SD 1.8, respectively, Wilcoxon rank-sum test, P < 0.01). Total costs of the ART-based approach and the SC group were 178 217, respectively. Based on probabilistic sensitivity analysis, 36 was saved per additional dental treatment. The probability that the ART-based approach is cost-saving was 63%. Specialist dental treatment fees had a big impact on the cost-effectiveness estimates.
Conclusion:
The ART-based approach appears to be a worthwhile intervention because it resulted in fewer referred cases and enabled more treatments to be provided with cost-savings.
Objectives. To assess and compare the cumulative survival rate of amalgam and atraumatic restorative treatment (ART) restorations in primary molars over 3 years.
Methods. 280 children aged 6–7 years old were enrolled in a cluster randomized controlled clinical trial using a parallel group design covering two treatment groups: conventional restorative treatment with amalgam (CRT) and atraumatic restorative treatment (ART) using a high-viscosity glass-ionomer (HVGIC) Ketac Molar Easymix. Three pedodontists placed 750 restorations (364 amalgam and 386 ART in 126 and 154 children, respectively) which were evaluated at 0.5, 1, 2 and 3 years. The proportional hazard rate regression model with frailty correction, ANOVA and Wald tests, and the Jackknife procedure were applied in analysing the data.
Results. The cumulative survival rates over 3 years for all, single- and multiple-surface CRT/amalgam restorations (72.6%, 93.4%, 64.7%, respectively) were no different from those of comparable ART/HVGIC restorations (66.8%; 90.1% and 56.4%, respectively) (p = 0.10). Single- surface restorations had higher survival rates than multiple-surface restorations for the both treatment procedures (p < 0.0001). A higher proportion of restorations failed because of mechanical reasons (94.8%) than of secondary caries (5.2%). No difference in reasons for restoration failures between all types of amalgam and ART/HVGIC restorations were observed (p = 0.24).
Significance. The high-viscosity glass-ionomer used in this study in conjunction with the ART is a viable option for restoring carious dentin lesions in single surfaces in vital primary molars.
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