Best-practice prevention alone or with conventional or biological caries management for 3- to 7-year-olds: the FiCTION three-arm RCT
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)...
| Main Authors: | , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
NIHR Journals Library
2020-01-01
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| Series: | Health Technology Assessment |
| Subjects: | |
| Online Access: | https://doi.org/10.3310/hta24010 |
| _version_ | 1811328592897900544 |
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| author | Anne Maguire Jan E Clarkson Gail VA Douglas Vicky Ryan Tara Homer Zoe Marshman Elaine McColl Nina Wilson Luke Vale Mark Robertson Alaa Abouhajar Richard D Holmes Ruth Freeman Barbara Chadwick Christopher Deery Ferranti Wong Nicola PT Innes |
| author_facet | Anne Maguire Jan E Clarkson Gail VA Douglas Vicky Ryan Tara Homer Zoe Marshman Elaine McColl Nina Wilson Luke Vale Mark Robertson Alaa Abouhajar Richard D Holmes Ruth Freeman Barbara Chadwick Christopher Deery Ferranti Wong Nicola PT Innes |
| author_sort | Anne Maguire |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-13T15:27:49Z |
| format | Article |
| id | doaj.art-7006d276c0624711822b48f16e5005f0 |
| institution | Directory Open Access Journal |
| issn | 1366-5278 2046-4924 |
| language | English |
| last_indexed | 2024-04-13T15:27:49Z |
| publishDate | 2020-01-01 |
| publisher | NIHR Journals Library |
| record_format | Article |
| series | Health Technology Assessment |
| spelling | doaj.art-7006d276c0624711822b48f16e5005f02022-12-22T02:41:27ZengNIHR Journals LibraryHealth Technology Assessment1366-52782046-49242020-01-0124110.3310/hta2401007/44/03Best-practice prevention alone or with conventional or biological caries management for 3- to 7-year-olds: the FiCTION three-arm RCTAnne Maguire0Jan E Clarkson1Gail VA Douglas2Vicky Ryan3Tara Homer4Zoe Marshman5Elaine McColl6Nina Wilson7Luke Vale8Mark Robertson9Alaa Abouhajar10Richard D Holmes11Ruth Freeman12Barbara Chadwick13Christopher Deery14Ferranti Wong15Nicola PT Innes16School of Dental Sciences, Newcastle University, Newcastle upon Tyne, UKDental Health Services Research Unit, University of Dundee, Dundee, UKDental School, University of Leeds, Leeds, UKInstitute of Health & Society, Newcastle University, Newcastle upon Tyne, UKInstitute of Health & Society, Newcastle University, Newcastle upon Tyne, UKSchool of Clinical Dentistry, University of Sheffield, Sheffield, UKInstitute of Health & Society, Newcastle University, Newcastle upon Tyne, UKInstitute of Health & Society, Newcastle University, Newcastle upon Tyne, UKInstitute of Health & Society, Newcastle University, Newcastle upon Tyne, UKDental Health Services Research Unit, University of Dundee, Dundee, UKNewcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UKSchool of Dental Sciences, Newcastle University, Newcastle upon Tyne, UKDental Health Services Research Unit, University of Dundee, Dundee, UKSchool of Dentistry, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UKSchool of Clinical Dentistry, University of Sheffield, Sheffield, UKInstitute of Dentistry, Queen Mary University of London, London, UKSchool of Dentistry, University of Dundee, Dundee, UKBackground: 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.https://doi.org/10.3310/hta24010dental cariescaries preventionprimary teethpreventionpaediatric dentistryrestorationfillingsprimary caredental anxietyquality of lifetooth, deciduouscost-effectiveness |
| spellingShingle | Anne Maguire Jan E Clarkson Gail VA Douglas Vicky Ryan Tara Homer Zoe Marshman Elaine McColl Nina Wilson Luke Vale Mark Robertson Alaa Abouhajar Richard D Holmes Ruth Freeman Barbara Chadwick Christopher Deery Ferranti Wong Nicola PT Innes Best-practice prevention alone or with conventional or biological caries management for 3- to 7-year-olds: the FiCTION three-arm RCT Health Technology Assessment dental caries caries prevention primary teeth prevention paediatric dentistry restoration fillings primary care dental anxiety quality of life tooth, deciduous cost-effectiveness |
| title | Best-practice prevention alone or with conventional or biological caries management for 3- to 7-year-olds: the FiCTION three-arm RCT |
| title_full | Best-practice prevention alone or with conventional or biological caries management for 3- to 7-year-olds: the FiCTION three-arm RCT |
| title_fullStr | Best-practice prevention alone or with conventional or biological caries management for 3- to 7-year-olds: the FiCTION three-arm RCT |
| title_full_unstemmed | Best-practice prevention alone or with conventional or biological caries management for 3- to 7-year-olds: the FiCTION three-arm RCT |
| title_short | Best-practice prevention alone or with conventional or biological caries management for 3- to 7-year-olds: the FiCTION three-arm RCT |
| title_sort | best practice prevention alone or with conventional or biological caries management for 3 to 7 year olds the fiction three arm rct |
| topic | dental caries caries prevention primary teeth prevention paediatric dentistry restoration fillings primary care dental anxiety quality of life tooth, deciduous cost-effectiveness |
| url | https://doi.org/10.3310/hta24010 |
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