Regimes of SDF Compared with Tiefenfluorid for Severe Early Childhood Caries – Randomised Clinical Trial

Description

Effective non-invasive management options and regimes for dental caries affecting primary dentition are still being developed. These usually include topical fluoride, but new formulations can be brought to market without establishing their efficacy. This clinical study compared market standard 38% silver diammine fluoride (SDF, SDI Riva Star) with a novel formulation Tiefenfluorid (TF, Humanchemie GmbH) for major failures (pain, abscess, extraction) and minor failures (lesion progression) in children ≤71 months of age with early, and severe-early childhood caries.. This randomised control, six-arm, patient/parent-blinded, superiority, placebo-controlled clinical trial (Institute of Stomatology, Riga Stradins University, Latvia), from 01/9/2020 to 01/08/2022 (Ethics Committee Nr.6-1/06/20) compared: 1) SDF four applications, one week apart (SDF1); 2) SDF biannually (SDF2); 3) TF four applications, one week apart (TF1); 4) TF biannually (TF2); 5) placebo four initial applications, one week apart (P1) and 6) placebo biannually (P2). Data analyses and visualisation: R statistics programme (R Core Team, 2013).. 428 children were randomised with loss to follow-up of 12.6% (7.0-18.6%). The mean (min, max, SD) follow-up time was 374 (315, 536, 39) days.
Primary outcome results: SDF2 group had a statistically significantly lower rate of major failures at 21.5% compared to the other groups (p<0.001) with SDF1=45.5%; P2=48.3%; P1=49.2%; TF2=50.9% and TF1=53.0%).
Secondary outcome results: Biannual SDF application resulted in the highest rate of lesion arrest with 50.4% of lesions arrested in SDF2 group, 42.7% in SDF1, 39.2% in TF2, 27.7% in TF1, 24.8% in P2 and 20.1% in P1.. In Latvian children referred for treatment for early and severe-early childhood caries, SDF applied biannually prevented more pain, abscesses and the need for extractions as well as resulting in a higher rate of lesion arrest compared to the other fluoride regimes and placebos. Funding: European Regional Development Fund 1.1.1.2/VIAA/3/19/543, Contract No 9.-14.5/27.

Period	30 Mar 2023
Event title	RSU International Research Conference 2023: Knowledge for Use in Practice
Event type	Conference
Organiser	Rīga Stradiņš University
Location	Riga, LatviaShow on map
Degree of Recognition	National