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

Research output: Working paper

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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.
Original languageEnglish
PublisherResearch Square
Number of pages12
DOIs
Publication statusSubmitted - 18 Oct 2023

Keywords*

  • silver diammine fluoride
  • non-invasive caries management
  • early childhood caries
  • randomised controlled trial
  • patient-centred outcomes research

Field of Science*

  • 3.2 Clinical medicine

Publication Type*

  • 6. Other publications

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