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.

Dental Caries and Its Management

“…The selective caries removal method is based on the decay's proximity to the pulp [ 3 , 5 , 7 , 39 ]. As a result, soft dentine may be removed or left in place to avoid pulp exposure.…”

“…In general, there are two approaches to caries removal of cavitated carious lesions in teeth with sensible and asymptomatic pulps: nonselective caries removal and selective caries removal [3,5,7,39].…”

“…In general, there are two approaches to caries removal of cavitated carious lesions in teeth with sensible and asymptomatic pulps: nonselective caries removal and selective caries removal [ 3 , 5 , 7 , 39 ]. The nonselective caries removal (complete caries removal) approach -It is the traditional method of treating dental caries [ 3 , 40 ].…”

“… The selective caries removal approach In this method, caries are selectively removed according to their proximity to the pulp, and therefore, soft and/or firm dentine is left and preserved. This approach is also known as the partial caries removal (PCR) method [ 3 , 5 , 7 , 39 ]. This approach is categorised into a one- or two-step method [ 1 ].…”

Minimally invasive selective caries removal: a clinical guide

“…This is partly caused by the lack of high-quality, definitive scientific evidence behind this technique, particularly in the permanent dentition, since most studies are obtained from trials on the primary dentition. 5 For this reason, the SCRiPT trial is currently being undertaken to clarify confusion around this subject. 5 Using the currently available literature pertaining to selective caries removal, this clinical technique guide aims to visually document the procedural steps and to justify its rationale when restoring moderate-to-deep depth carious lesions with direct methacrylate resin composite restorations in clinical practice.…”