Innes, NP, Clarkson, JE, Douglas, GVA orcid.org/0000-0002-0531-3909 et al. (14 more authors) (2020) Child Caries Management: A Randomized Controlled Trial in Dental Practice. Journal of Dental Research, 99 (1). pp. 36-43. ISSN 0022-0345
Abstract
This multicenter 3-arm, parallel-group, patient-randomized controlled trial compared clinical effectiveness of 3 treatment strategies over 3 y for managing dental caries in primary teeth in UK primary dental care. Participants aged 3 to 7 y with at least 1 primary molar with dentinal carious lesion were randomized across 3 arms (1:1:1 via centrally administered system with variable-length random permuted blocks): C+P, conventional carious lesion management (complete carious tooth tissue removal and restoration placement) with prevention; B+P, biological management (sealing in carious tooth tissue restoratively) with prevention; and PA, prevention alone (diet, plaque removal, fluorides, and fissure sealants). Parents, children, and dentists were not blind to allocated arm. Co–primary outcomes were 1) the proportion of participants with at least 1 episode of dental pain and/or infection and 2) the number of episodes of dental pain and/or infection during follow-up (minimum, 23 mo). In sum, 1,144 participants were randomized (C+P, n = 386; B+P, n = 381; PA, n = 377) by 72 general dental practitioners, of whom 1,058 (C+P, n = 352; B+P, n = 352; PA, n = 354) attended at least 1 study visit and were included in the primary analysis. The median follow-up was 33.8 mo (interquartile range, 23.8 to 36.7). Proportions of participants with at least 1 episode of dental pain and/or infection were as follows: C+P, 42%; B+P, 40%; PA, 45%. There was no evidence of a difference in incidence of dental pain and/or infection when B+P (adjusted risk difference [97.5% CI]: −2% [−10% to 6%]) or PA (4% [−4% to 12%]) was compared with C+P. The mean (SD) number of episodes of dental pain and/or infection were as follows: C+P, 0.62 (0.95); B+P, 0.58 (0.87); and PA, 0.72 (0.98). Superiority could not be concluded for number of episodes between B+P (adjusted incident rate ratio (97.5% CI): 0.95 [0.75 to 1.21]) or PA (1.18 [0.94 to 1.48]) and C+P. In conclusion, there was no evidence of a difference among the 3 treatment approaches for incidence or number of episodes of dental pain and/or infection experienced by these participants with high caries risk and established disease (trial registration: ISRCTN77044005).
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © International & American Associations for Dental Research 2019. This is an author produced version of a paper published in the Journal of Dental Research. Uploaded in accordance with the publisher's self-archiving policy. |
Keywords: | dental caries, pediatric dentistry, restoration, clinical studies/trials, dental public health, primary dentition |
Dates: |
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Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Dentistry (Leeds) > Applied Health and Clinical Translation (Leeds) |
Funding Information: | Funder Grant number NIHR National Inst Health Research 07/44/03 |
Depositing User: | Symplectic Publications |
Date Deposited: | 05 Dec 2019 11:02 |
Last Modified: | 07 Jan 2020 10:07 |
Status: | Published |
Publisher: | SAGE Publications |
Identification Number: | 10.1177/0022034519888882 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:149436 |