Maldupa, IlzeInnes, NicolaViduskalne, IlonaBrinkmane, AndaSenakola, EgitaKrūmiņa, KarīnaUribe, Sergio E2024-04-162024-04-162024-04-07Maldupa, I, Innes, N, Viduskalne, I, Brinkmane, A, Senakola, E, Krūmiņa, K & Uribe, S E 2024, 'Clinical effectiveness/child-patient and parent satisfaction of two topical fluoride treatments for caries : a randomised clinical trial', Scientific Reports, vol. 14, no. 1, 8123, pp. 1-11. https://doi.org/10.1038/s41598-024-58850-w2045-2322PubMedCentral: PMC10998894https://dspace.rsu.lv/jspui/handle/123456789/15432Publisher Copyright: © The Author(s) 2024.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: 30/06/2021.113283506enginfo:eu-repo/semantics/openAccessHumansChild, PreschoolCariostatic Agents/therapeutic useFluoride TreatmentDental Caries/prevention & controlDental Caries SusceptibilityPatient SatisfactionFluorides, Topical/therapeutic useTreatment OutcomeSilver Compounds/therapeutic useQuaternary Ammonium Compounds/therapeutic useParentsPersonal Satisfaction3.2 Clinical medicine1.1. Scientific article indexed in Web of Science and/or Scopus database/dk/atira/pure/researchoutput/researchoutputtypes/contributiontojournal/article10.1038/s41598-024-58850-whttp://www.scopus.com/inward/record.url?scp=85189312631&partnerID=8YFLogxK