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Selective Caries Removal in Permanent Teeth (SCRiPT) for the treatment of deep carious lesions: a randomised controlled clinical trial in primary care
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 adu...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8267238/ https://www.ncbi.nlm.nih.gov/pubmed/34243733 http://dx.doi.org/10.1186/s12903-021-01637-6 |
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author | Clarkson, Jan E. Ramsay, Craig R. Ricketts, David Banerjee, Avijit Deery, Chris Lamont, Thomas Boyers, Dwayne Marshman, Zoe Goulao, Beatriz Banister, Katie Conway, David Dawett, Bhupinder Baker, Sarah Sherriff, Andrea Young, Linda van der Pol, Marjon MacLennan, Graeme Floate, Ruth Braid, Hazel Fee, Patrick Forrest, Mark Gouick, Jill Mitchell, Fiona Gupta, Ekta Dakri, Riz Kettle, Jennifer McGuff, Tina Dunn, Katharine |
author_facet | Clarkson, Jan E. Ramsay, Craig R. Ricketts, David Banerjee, Avijit Deery, Chris Lamont, Thomas Boyers, Dwayne Marshman, Zoe Goulao, Beatriz Banister, Katie Conway, David Dawett, Bhupinder Baker, Sarah Sherriff, Andrea Young, Linda van der Pol, Marjon MacLennan, Graeme Floate, Ruth Braid, Hazel Fee, Patrick Forrest, Mark Gouick, Jill Mitchell, Fiona Gupta, Ekta Dakri, Riz Kettle, Jennifer McGuff, Tina Dunn, Katharine |
author_sort | Clarkson, Jan E. |
collection | PubMed |
description | 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12903-021-01637-6. |
format | Online Article Text |
id | pubmed-8267238 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-82672382021-07-09 Selective Caries Removal in Permanent Teeth (SCRiPT) for the treatment of deep carious lesions: a randomised controlled clinical trial in primary care Clarkson, Jan E. Ramsay, Craig R. Ricketts, David Banerjee, Avijit Deery, Chris Lamont, Thomas Boyers, Dwayne Marshman, Zoe Goulao, Beatriz Banister, Katie Conway, David Dawett, Bhupinder Baker, Sarah Sherriff, Andrea Young, Linda van der Pol, Marjon MacLennan, Graeme Floate, Ruth Braid, Hazel Fee, Patrick Forrest, Mark Gouick, Jill Mitchell, Fiona Gupta, Ekta Dakri, Riz Kettle, Jennifer McGuff, Tina Dunn, Katharine BMC Oral Health Study Protocol 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12903-021-01637-6. BioMed Central 2021-07-09 /pmc/articles/PMC8267238/ /pubmed/34243733 http://dx.doi.org/10.1186/s12903-021-01637-6 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol Clarkson, Jan E. Ramsay, Craig R. Ricketts, David Banerjee, Avijit Deery, Chris Lamont, Thomas Boyers, Dwayne Marshman, Zoe Goulao, Beatriz Banister, Katie Conway, David Dawett, Bhupinder Baker, Sarah Sherriff, Andrea Young, Linda van der Pol, Marjon MacLennan, Graeme Floate, Ruth Braid, Hazel Fee, Patrick Forrest, Mark Gouick, Jill Mitchell, Fiona Gupta, Ekta Dakri, Riz Kettle, Jennifer McGuff, Tina Dunn, Katharine Selective Caries Removal in Permanent Teeth (SCRiPT) for the treatment of deep carious lesions: a randomised controlled clinical trial in primary care |
title | Selective Caries Removal in Permanent Teeth (SCRiPT) for the treatment of deep carious lesions: a randomised controlled clinical trial in primary care |
title_full | Selective Caries Removal in Permanent Teeth (SCRiPT) for the treatment of deep carious lesions: a randomised controlled clinical trial in primary care |
title_fullStr | Selective Caries Removal in Permanent Teeth (SCRiPT) for the treatment of deep carious lesions: a randomised controlled clinical trial in primary care |
title_full_unstemmed | Selective Caries Removal in Permanent Teeth (SCRiPT) for the treatment of deep carious lesions: a randomised controlled clinical trial in primary care |
title_short | Selective Caries Removal in Permanent Teeth (SCRiPT) for the treatment of deep carious lesions: a randomised controlled clinical trial in primary care |
title_sort | selective caries removal in permanent teeth (script) for the treatment of deep carious lesions: a randomised controlled clinical trial in primary care |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8267238/ https://www.ncbi.nlm.nih.gov/pubmed/34243733 http://dx.doi.org/10.1186/s12903-021-01637-6 |
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