European archives of paediatric dentistry : official journal of the European Academy of Paediatric Dentistry · 2025
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.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
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Olegário Isabel Cristina, Castelo Branco Camila, Cavalcanti Ana Beatriz, Breen Tara, Collins Richard, Ward Hannah Elizabeth, Fitzpatrick Caoimhe, Araujo Maia Silva Cristiane
Аннотация
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.
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.