Dataset Information

Selective Caries Removal in Permanent Teeth (SCRiPT) for the treatment of deep carious lesions: a randomised controlled clinical trial in primary care.

ABSTRACT:

Background

Dental caries is one of the most prevalent non-communicable disease globally and can have serious health sequelae impacting negatively on quality of life. In the UK most adults experience dental caries during their lifetime and the 2009 Adult Dental Health Survey reported that 85% of adults have at least one dental restoration. Conservative removal of tooth tissue for both primary and secondary caries reduces the risk of failure due to tooth-restoration, complex fracture as well as remaining tooth surfaces being less vulnerable to further caries. However, despite its prevalence there is no consensus on how much caries to remove prior to placing a restoration to achieve optimal outcomes. Evidence for selective compared to complete or near-complete caries removal suggests there may be benefits for selective removal in sustaining tooth vitality, therefore avoiding abscess formation and pain, so eliminating the need for more complex and costly treatment or eventual tooth loss. However, the evidence is of low scientific quality and mainly gleaned from studies in primary teeth.

Method

This is a pragmatic, multi-centre, two-arm patient randomised controlled clinical trial including an internal pilot set in primary dental care in Scotland and England. Dental health professionals will recruit 623 participants over 12-years of age with deep carious lesions in their permanent posterior teeth. Participants will have a single tooth randomised to either the selective caries removal or complete caries removal treatment arm. Baseline measures and outcome data (during the 3-year follow-up period) will be assessed through clinical examination, patient questionnaires and NHS databases. A mixed-method process evaluation will complement the clinical and economic outcome evaluation and examine implementation, mechanisms of impact and context. The primary outcome at three years is sustained tooth vitality. The primary economic outcome is net benefit modelled over a lifetime horizon. Clinical secondary outcomes include pulp exposure, progession of caries, restoration failure; as well as patient-centred and economic outcomes.

Discussion

SCRiPT will provide evidence for the most clinically effective and cost-beneficial approach to managing deep carious lesions in permanent posterior teeth in primary care. This will support general dental practitioners, patients and policy makers in decision making. Trial Registration Trial registry: ISRCTN.

Trial registration number

ISRCTN76503940. Date of Registration: 30.10.2019. URL of trial registry record: https://www.isrctn.com/ISRCTN76503940?q=ISRCTN76503940%20&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10&searchType=basic-search .

SUBMITTER: Clarkson JE

PROVIDER: S-EPMC8267238 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ObjectivesThe aim of this randomized clinical trial was to compare selective removal to soft dentin (SRSD) and selective removal to firm dentin (SRFD) in permanent teeth. The primary outcome of the study was to compare the success rates of the two caries removal techniques. The secondary outcome of the study was to investigate whether or not calcium silicate-based material (CS) had an effect on the success rate of the treatment.Materials and methodsBetween November 2018 and March 2020, patients with deep caries lesions were invited to participate in the study. Posterior teeth (N = 165) with primary caries lesion radiographically extending ¾ of dentin and positive response to cold test were randomly selected. A total of 134 participants meeting the inclusion criteria were randomized to SRSD and SRFD (control) groups. After the caries removal procedure, teeth with exposed pulps were assigned to the pulp exposure (PE) group, and the SRSD group was further divided into test 1 (with CS) and test 2 groups (without CS). Success was defined as a positive response to the cold test, a negative response to percussion, the absence of pain, an abscess, a fistula, and periapical alterations. Fisher-Freeman-Halton exact tests, Kaplan-Meier survival analysis, and the log-rank tests were performed for comparisons between groups.ResultsNo statistically significant difference was found between the success rates of test 1 (100%) and test 2 (93.5%) groups, whereas the proportion of success in control (82.4%) and PE (84%) groups were significantly lower when compared with test groups (p = 0.024; p < 0.05) at the end of 2-year follow-up.ConclusionsSRSD had a higher success rate when compared to SRFD to treat deep carious lesions after 2 years of follow-up. The use of CS material after SRSD as a liner had no effect on the treatment outcome.Clinical relevanceSRSD with good coronal sealing might be recommended without CS application for the treatment of deep caries lesions in permanent teeth.Trial registrationClinical trial registration number NCT04052685 (08/09/2019).

Project description:BackgroundWhen silver diamine fluoride (SDF) is used in conjunction with conservative caries removal in deep carious lesions, the distribution depth of silver is critical for safety and effectiveness.ObjectiveThe purpose of this study is to determine the effect of selected caries removal on silver penetration when 38% SDF is applied to deep carious lesions in permanent teeth.MethodsExtracted permanent teeth with caries extending to the inner third of the dentin were used (N = 18). The periphery of the carious lesion was completely removed to the dentinoenamel junction (DEJ). In group A (n = 9), no further removal of carious tissue was performed, leaving necrotic dentin inner to the DEJ, whereas in group B (n = 9) superficial necrotic dentin was completely removed until leathery, slightly moist, reasonably soft dentin remained. SDF was applied for 3 minutes in both groups. Microcomputer tomography (micro-CT) and field emission scanning electron microscopy coupled with energy-dispersive X-ray spectroscopy (FESEM-EDS) were used to measure mineral density and silver distribution. The silver penetration depth/lesion depth (PD/LD) ratio was calculated for each sample. The Mann-Whitney U test was used to compare differences between the two groups.ResultsThe micro-CT analysis showed that the PD/LD ratios of group B (1.07-2.29) were marginally greater than those of group A (1.00-1.31). However, a statistically significant difference was not observed (pvalue = 0.5078). When stratified by remaining dentin thickness (RDT), the PD/LD ratios of group B were still greater than those of group A only when RDT was >500 µm. The FESEM-EDS analysis indicated that silver particles precipitated throughout the entire thickness of the carious lesions.ConclusionApplying SDF on a deep carious lesion and leaving the necrotic dentin pulpally did not affect silver penetration. However, the extent to which silver penetrates the remaining dentin beneath the lesions is dependent on the amount and characteristics of that dentin.

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