Outcomes in randomised controlled trials in prevention and management of carious lesions: a systematic review

Levey, Colin; Innes, Nicola; Schwendicke, Falk; Lamont, Thomas; Göstemeyer, Gerd

doi:10.1186/s13063-017-2256-1

Cited by 21 publications

(26 citation statements)

References 37 publications

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“…Last, assessing restoration failure as a surrogate for the clinical effectiveness of the treatment might be debatable, especially in light of the demands of institutionalised older people. Other parameters might be more important for the quality of life of this population group, and patient‐related outcomes should be collected by future studies …”

Section: Discussionmentioning

confidence: 99%

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Atraumatic vs conventional restorative treatment for root caries lesions in older patients: Meta‐ and trial sequential analysis

et al. 2019

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Objectives We aimed to appraise the comparative clinical efficacy of atraumatic restorative treatment (ART) versus conventional restorative treatment (CT) using a meta‐analysis, and assessed the robustness of evidence by trial sequential analysis (TSA). Background Due to its simplified clinical approach, ART may be advantageous over CT for restoration of root caries lesions in institutionalised older patients. Methods Three electronic databases (PubMed, Embase and Cochrane CENTRAL) were screened, and hand searches and cross‐referencing performed to identify randomised controlled trials reporting on survival of ART vs CT for restoration of root caries in older patients. Trial selection, data extraction and risk of bias assessment were performed by two independent reviewers. ART and CT were compared using fixed‐ or random‐effects pairwise meta‐analysis for per‐protocol (PP), intention‐to‐treat (ITT) and best‐case scenarios. TSA was used to control for risk of random errors. Results A total of 235 studies were identified, and three trials involving 130 patients (463 restorations) were included. Risk of bias was high or moderate in all but one trial. ART was associated with a significantly increased risk of failure (OR [95% CI] 2.06 [1.06/4.00]) in PP‐ but not in ITT analysis (1.36 [0.92/2.02]). Analyses for best‐case scenarios found great uncertainty introduced by attrition. No firm evidence was reached according to TSA. Conclusions For restoration of root caries, there is insufficient data to clearly rule out whether differences between ART and CT exist. Limited available data indicate there might be an increased risk of failure for ART.

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Section: Discussionmentioning

confidence: 99%

“…Other parameters might be more important for the quality of life of this population group, and patient-related outcomes should be collected by future studies. 36…”

Section: Due To Its Reduced Instrumental and Technical Requirementsmentioning

confidence: 99%

Atraumatic vs conventional restorative treatment for root caries lesions in older patients: Meta‐ and trial sequential analysis

et al. 2019

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“…However, both the research quality and its generalisability to a primary dental setting is limited 7,31 and a closer look at the evidence shows less clarity, because a limitation in its interpretation is the lack of an agreed core outcome set. 32,33 Cariology studies use a variety of different outcomes and different outcomes measures, making it often impossible to synthesise or directly compare materials and techniques. Few studies have measured caries-related pain and infection as an outcome when comparing different treatment approaches and fewer still have compared conventional (complete) carious lesion removal and restoration approaches with other approaches to managing carious lesions.…”

Section: The Evidence For Effective Management Of Carious Lesions Inmentioning

confidence: 99%

“…The value of children's opinions on their dental treatment experiences has become more widely accepted and their perspectives are seen as credible. Although a vast body of research has compared different types of treatment to manage carious lesions, most of the research has focused on outcomes related to choice and characteristics of dental materials; 33 very little research has included the preferences or perspectives of participants as outcomes.…”

Section: Child-and Parent-reported Outcomes: Oral Health-related Qualmentioning

confidence: 99%

Best-practice prevention alone or with conventional or biological caries management for 3- to 7-year-olds: the FiCTION three-arm RCT

Maguire

Clarkson

Douglas

et al. 2020

Health Technol Assess

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Background Historically, lack of evidence for effective management of decay in primary teeth has caused uncertainty, but there is emerging evidence to support alternative strategies to conventional fillings, which are minimally invasive and prevention orientated. Objectives The objectives were (1) to assess the clinical effectiveness and cost-effectiveness of three strategies for managing caries in primary teeth and (2) to assess quality of life, dental anxiety, the acceptability and experiences of children, parents and dental professionals, and caries development and/or progression. Design This was a multicentre, three-arm parallel-group, participant-randomised controlled trial. Allocation concealment was achieved by use of a centralised web-based randomisation facility hosted by Newcastle Clinical Trials Unit. Setting This trial was set in primary dental care in Scotland, England and Wales. Participants Participants were NHS patients aged 3–7 years who were at a high risk of tooth decay and had at least one primary molar tooth with decay into dentine, but no pain/sepsis. Interventions Three interventions were employed: (1) conventional with best-practice prevention (local anaesthetic, carious tissue removal, filling placement), (2) biological with best-practice prevention (sealing-in decay, selective carious tissue removal and fissure sealants) and (3) best-practice prevention alone (dietary and toothbrushing advice, topical fluoride and fissure sealing of permanent teeth). Main outcome measures The clinical effectiveness outcomes were the proportion of children with at least one episode (incidence) and the number of episodes, for each child, of dental pain or dental sepsis or both over the follow-up period. The cost-effectiveness outcomes were the cost per incidence of, and cost per episode of, dental pain and/or dental sepsis avoided over the follow-up period. Results A total of 72 dental practices were recruited and 1144 participants were randomised (conventional arm, n = 386; biological arm, n = 381; prevention alone arm, n = 377). Of these, 1058 were included in an intention-to-treat analysis (conventional arm, n = 352; biological arm, n = 352; prevention alone arm, n = 354). The median follow-up time was 33.8 months (interquartile range 23.8–36.7 months). The proportion of children with at least one episode of pain or sepsis or both was 42% (conventional arm), 40% (biological arm) and 45% (prevention alone arm). There was no evidence of a difference in incidence or episodes of pain/sepsis between arms. When comparing the biological arm with the conventional arm, the risk difference was –0.02 (97.5% confidence interval –0.10 to 0.06), which indicates, on average, a 2% reduced risk of dental pain and/or dental sepsis in the biological arm compared with the conventional arm. Comparing the prevention alone arm with the conventional arm, the risk difference was 0.04 (97.5% confidence interval –0.04 to 0.12), which indicates, on average, a 4% increased risk of dental pain and/or dental sepsis in the prevention alone arm compared with the conventional arm. Compared with the conventional arm, there was no evidence of a difference in episodes of pain/sepsis among children in the biological arm (incident rate ratio 0.95, 97.5% confidence interval 0.75 to 1.21, which indicates that there were slightly fewer episodes, on average, in the biological arm than the conventional arm) or in the prevention alone arm (incident rate ratio 1.18, 97.5% confidence interval 0.94 to 1.48, which indicates that there were slightly more episodes in the prevention alone arm than the conventional arm). Over the willingness-to-pay values considered, the probability of the biological treatment approach being considered cost-effective was approximately no higher than 60% to avoid an incidence of dental pain and/or dental sepsis and no higher than 70% to avoid an episode of pain/sepsis. Conclusions There was no evidence of an overall difference between the three treatment approaches for experience of, or number of episodes of, dental pain or dental sepsis or both over the follow-up period. Future work Recommendations for future work include exploring barriers to the use of conventional techniques for carious lesion detection and diagnosis (e.g. radiographs) and developing and evaluating suitable techniques and strategies for use in young children in primary care. Trial registration Current Controlled Trials ISRCTN77044005. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 1. See the NIHR Journals Library website for further project information.

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“…Имеется также недостаток данных по экономическому эффекту применения самостоя-тельных профилактических мероприятий пациента-ми, что осложняет принятие ими взвешенных реше-ний по выбору способов гигиены [5]. Более того, исследования эффективности даже самых распро-страненных профилактических практик не улучша-ют понимание ситуации [6]. В то же время даже не-значительные изменения гигиенических привычек могут привести к заметному снижению экономиче-ской нагрузки (по некоторым оценкам, 1 долл.…”

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Retrospective cohort study of clinical and economical effectiveness of dentifrices from different manufacturers

Kopetsky¹,

Nikolskaya²,

Agaev³

et al. 2018

Ross. stomatol.

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Outcomes in randomised controlled trials in prevention and management of carious lesions: a systematic review

Cited by 21 publications

References 37 publications

Atraumatic vs conventional restorative treatment for root caries lesions in older patients: Meta‐ and trial sequential analysis

Atraumatic vs conventional restorative treatment for root caries lesions in older patients: Meta‐ and trial sequential analysis

Best-practice prevention alone or with conventional or biological caries management for 3- to 7-year-olds: the FiCTION three-arm RCT

Retrospective cohort study of clinical and economical effectiveness of dentifrices from different manufacturers

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