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Background <p>Ammonia-free silver fluoride formulations have been developed to reduce unpleasant taste and potential mucosal irritation associated with conventional silver diamine fluoride (SDF) products.</p> Aim <p>To compare RIVA STAR AQUA and RIVA STAR in terms of the presence of adverse effects, short-term caries lesion discolouration, and child-reported discomfort during treatment.</p> Design <p>In this randomized clinical trial, 4–10-year-old children with cavitated caries lesions exposing dentine in primary molars (ICDAS 5–6) were recruited from public schools in&#xa0;João Pessoa and Guarabira, Brazil. Participants were allocated to receive either RIVA STAR AQUA (test) or RIVA STAR (control). Adverse effects (soft-tissue ulceration, allergy, nausea/vomiting, bad taste, tooth pain/sensitivity, pigmentation, esthetic concerns) were assessed immediately and after 1&#xa0;week. Child-reported discomfort was recorded using the Wong–Baker faces scale. Data were analyzed using <i>t </i>tests, Mann–Whitney <i>U</i>, chi-square, and ordinal logistic regression (<i>α</i> = 5%).</p> Results <p>85 children (155 teeth) were re-examined after 1&#xa0;week (3.4% loss to follow-up). Overall adverse effects occurred in 74.8% of teeth, with no difference in total incidence between groups. RIVA STAR AQUA resulted in fewer reports of bad taste and soft-tissue ulceration. Discomfort scores were low with no significant between-group difference (OR = 0.52; <i>p</i> = 0.076). Dark discolouration was observed in 87.1% of teeth after 1&#xa0;week.</p> Conclusion <p>RIVA STAR AQUA may be a suitable alternative to RIVA STAR with no differences in the overall presence of adverse effects and fewer taste-related complaints and mucosal ulcerations, without increasing discomfort. Long-term studies are warranted to assess its caries lesion arrest effectiveness.</p> Clinical trial registration <p>ReBEC RBR-2qz7vwt.</p>

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A randomized clinical trial of ammonia-free silver fluoride for treating cavitated dentine caries in primary teeth: adverse effects, short-term discolouration, and patient-reported outcomes

  • 期刊论文

  • 发表日期：

    2025年12月25日

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  • Isabel Cristina Olegário,
  • Camila Castelo Branco,
  • Ana Beatriz Cavalcanti,
  • Tara Breen,
  • Richard Collins,
  • Hannah Elizabeth Ward,
  • Caoimhe Fitzpatrick,
  • Cristiane Araujo Maia Silva

摘要

Background

Ammonia-free silver fluoride formulations have been developed to reduce unpleasant taste and potential mucosal irritation associated with conventional silver diamine fluoride (SDF) products.

Aim

To compare RIVA STAR AQUA and RIVA STAR in terms of the presence of adverse effects, short-term caries lesion discolouration, and child-reported discomfort during treatment.

Design

In this randomized clinical trial, 4–10-year-old children with cavitated caries lesions exposing dentine in primary molars (ICDAS 5–6) were recruited from public schools in João Pessoa and Guarabira, Brazil. Participants were allocated to receive either RIVA STAR AQUA (test) or RIVA STAR (control). Adverse effects (soft-tissue ulceration, allergy, nausea/vomiting, bad taste, tooth pain/sensitivity, pigmentation, esthetic concerns) were assessed immediately and after 1 week. Child-reported discomfort was recorded using the Wong–Baker faces scale. Data were analyzed using t tests, Mann–Whitney U, chi-square, and ordinal logistic regression (α = 5%).

Results

85 children (155 teeth) were re-examined after 1 week (3.4% loss to follow-up). Overall adverse effects occurred in 74.8% of teeth, with no difference in total incidence between groups. RIVA STAR AQUA resulted in fewer reports of bad taste and soft-tissue ulceration. Discomfort scores were low with no significant between-group difference (OR = 0.52; p = 0.076). Dark discolouration was observed in 87.1% of teeth after 1 week.

Conclusion

RIVA STAR AQUA may be a suitable alternative to RIVA STAR with no differences in the overall presence of adverse effects and fewer taste-related complaints and mucosal ulcerations, without increasing discomfort. Long-term studies are warranted to assess its caries lesion arrest effectiveness.

Clinical trial registration

ReBEC RBR-2qz7vwt.