Clinical effectiveness/child-patient and parent satisfaction of two topical fluoride treatments for caries: a randomised clinical trial

Maldupa, Ilze, Innes, Nicola ORCID: https://orcid.org/0000-0002-9984-0012, Viduskalne, Ilona, Brinkmane, Anda, Senakola, Egita, Krumina, Karina and Uribe, Sergio E. 2024. Clinical effectiveness/child-patient and parent satisfaction of two topical fluoride treatments for caries: a randomised clinical trial. Scientific Reports 14 (1) , 8123. 10.1038/s41598-024-58850-w

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Abstract

Knowledge gaps exist regarding optimal silver diammine fluoride (SDF) regimens and the efficacy of new products for arresting dental caries in young children. We evaluated the effectiveness of 38%-SDF (SDI-RivaStar), Tiefenfluorid (TF) comparing with Placebo (P), all in conjunction with behavioural modification (BM), in preventing major complications (endodontic/extractions/pain)—a patient-centred outcome—due to early childhood caries over 12 months in children under 71-months. A six-arm, patient/parent-blinded, superiority, placebo-controlled randomised control trial at the university clinic in Riga, Latvia, from 1/9/20-31/8/22 (Protocol registration ISRCTN17005348). The trial tested six protocols, using three compounds (P/SDF/TF) under two regimes: annual and biannual (P1/P2/TF1/TF2/SDF1/SDF2) for major complications. Secondary outcomes included minor complications and parental satisfaction. All groups received BM. 373/427 randomised children (87.3%) completed the study. SDF2 had a significantly lower rate and risk of major (21.5%, OR = 0.28, 95%CI [0.11, 0.72], p < 0.05) and minor complications (OR = 0.16 (95%CI [0.05, 0.50], p = 0.002). Overall satisfaction was 96% (p > 0.05). SDF biannual application with BM effectively prevented major complications of early childhood caries and was well accepted by children and their parents. Trial registration number: ISRCTN17005348, principal investigator: Ilze Maldupa, registration date: 30/06/2021. Clinical trial registration number: ISRCTN registry: ISRCTN17005348, https://doi.org/10.1186/ISRCTN17005348, registration date: 30/06/2021.

Item Type:	Article
Date Type:	Published Online
Status:	Published
Schools:	Healthcare Sciences
Additional Information:	License information from Publisher: LICENSE 1: URL: http://creativecommons.org/licenses/by/4.0/, Type: open-access
Publisher:	Nature Research
Date of First Compliant Deposit:	8 April 2024
Date of Acceptance:	3 April 2024
Last Modified:	08 Apr 2024 09:30
URI:	https://orca.cardiff.ac.uk/id/eprint/167785

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