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.
The authors would like to thank all the patients, dentists and dental team members who are participating in the SCRiPT Trial. We would also like to thank the members of the TSC and DMEC.
We would like to acknowledge funding for the project from the National Institute for Health Research Health Technology Assessment Programme (Pro- ject Number 17/127/07). The views and opinions expressed herein are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, NHS, or the Department of Health.
SPONSOR: University of Dundee.
FUNDER: National Institute for Health Research (NIHR), Health Technology Assessment (HTA) Programme, Project number: 17/127/07
The SCRiPT study group consists of the Co-Chief Investigators, Grant
Holders, Project Management Group and the Trial Management Committee as outlined below:
Co-Chief Investigators: Jan E Clarkson (JC) and Craig R Ramsay (CR). Grant Holders
Sarah Baker (SB), Avijit Banerjee (AB), Katie Bannister (KB), Dwayne Boyers
(DB), David Conway (DC), Bupinder Dawett (BD), Chris Deery (CD), Thomas Lamont (TL), Graeme MacLennan (GMacL), Zoe Marshmann (ZM), Tina McGuff (TMcG), David Ricketts (DR), Andrea Sherriff (AS), Marjon van der Pol (MvdP), Linda Young (LY),
Trial Management Committee
Sarah Baker (SB), Avijit Banerjee (AB), Hazel Braid (HB), Katie Bannister (KB), Dwayne Boyers (DB), David Conway (DC), Riz Dakri (RD), Bupinder Dawett (BD), Chris Deery (CD), Katharine Dunn (KD), Patrick Fee (PF), Ruth Floate (RF), Mark Forrest (MF), Jill Gouick (JG), Beatriz Goulao (BG), Ekta Gupta (EG), Jennifer Ket- tle (JK), Thomas Lamont (TL), Graeme MacLennan (GMacL), Zoe Marshmann (ZM), Fiona Mitchell (FM), Alison McDonald (AMcD), Tina McGuff (TMcG), David Ricketts (DR), Andrea Sherriff (AS), Marjon van der Pol (MvdP), Linda Young (LY)
This study is funded by the National Institute for Health Research (NIHR) Health Technology Assessment Program (project reference 17/127/07). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. The funding body has
had no role in the design of the study and will have no role in the collection, analysis, and interpretation of the data and in writing of any future manuscript.
- Complete caries removal
- Cost–benefit analysis
- Minimally invasive dentistry
- Oral-health-related quality of life
- Partial caries removal
- Patient-centred outcomes
- Primary care
- Randomised controlled trial
- Selective caries removal
- Willingness to pay