- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07728409
Silver Nanoparticle vs Chlorhexidine Mouthwashes for Reducing Streptococcus Mutans and Improving Salivary pH in Children (SMILE)
A Randomized Clinical Trial Comparing Silver Nanoparticle and Chlorhexidine Mouthwashes on Streptococcus Mutans Levels and Salivary pH in Pediatric Patients
Dental caries remains one of the most common chronic diseases in children, with Streptococcus mutans playing a major role in its development. Chlorhexidine mouthwash is an effective antimicrobial agent but its use in pediatric patients is limited by adverse effects such as tooth staining, taste alteration, and mucosal irritation. Silver nanoparticle (AgNP) mouthwash has emerged as a potential alternative with broad-spectrum antimicrobial activity and a potentially improved safety profile.
This randomized, double-blind, parallel-group clinical trial will compare the efficacy of 10 ppm silver nanoparticle mouthwash with 0.2% chlorhexidine mouthwash in reducing salivary Streptococcus mutans levels in children aged 6-12 years at high caries risk.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Dental caries remains the most prevalent chronic disease affecting children worldwide and continues to represent a major public health concern. The disease results from a complex interaction between dental biofilm, fermentable carbohydrates, susceptible tooth surfaces, and host factors. Among the microorganisms associated with caries development, Streptococcus mutans plays a central role because of its ability to adhere to tooth surfaces, synthesize extracellular polysaccharides, produce organic acids, and tolerate acidic environments. Consequently, reducing salivary and plaque levels of S. mutans is considered an important strategy for preventing and controlling dental caries in children at high caries risk.
Chlorhexidine gluconate is widely recognized as the reference antimicrobial mouthwash because of its broad-spectrum antibacterial activity and prolonged substantivity. Despite its effectiveness, routine use in pediatric patients may be limited by adverse effects, including tooth staining, taste alteration, oral mucosal irritation, and reduced patient acceptance during repeated use.
Silver nanoparticles (AgNPs) have attracted increasing interest as an alternative antimicrobial agent because of their broad-spectrum activity against oral microorganisms through multiple mechanisms, including disruption of bacterial cell membranes, interference with intracellular metabolic processes, and inhibition of biofilm formation. At appropriate concentrations, AgNP formulations have demonstrated favorable biocompatibility and may provide an alternative approach for reducing cariogenic bacteria while minimizing some of the undesirable effects associated with chlorhexidine.
This randomized, double-blind, parallel-group clinical trial is designed to evaluate the comparative effectiveness and safety of a silver nanoparticle mouthwash and a chlorhexidine mouthwash in children with high caries risk. The study will assess the antimicrobial effect of both interventions on salivary Streptococcus mutans while also evaluating changes in the oral environment and treatment tolerability. The findings are expected to provide evidence regarding whether silver nanoparticle mouthwash represents a suitable alternative to chlorhexidine for antimicrobial management in pediatric dentistry and to contribute to the development of safer and more acceptable preventive strategies for children at increased risk of dental caries.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Age 6-12 years with mixed dentition.
- American Society of Anesthesiologists (ASA) physical status I or II
- High caries risk, defined as DMFT/dmft score ≥ 3, Dentocult SM Strip mutans score ≥ 2, or salivary S. mutans ≥ 10⁵ CFU/mL at screening
- Presence of at least 20 natural teeth.
- No antibiotic therapy in the preceding 3 months.
- Parent/guardian willing to provide written informed consent.
- Child assent obtained using age-appropriate methods.
Exclusion Criteria:
- Systemic diseases affecting salivary flow (e.g., Sjögren's syndrome, uncontrolled diabetes, cystic fibrosis).
- Special healthcare needs or developmental disabilities affecting. compliance
- Active fixed or removable orthodontic appliances.
- History of allergy to silver compounds, chlorhexidine, or mint flavoring.
- Use of any antimicrobial mouthwash in the preceding 3 months.
- Active oral mucosal lesions or periodontal disease.
- Professional fluoride treatment within the past month.
- Participation in another clinical trial within the past 6 months.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Silver Nanoparticle Mouthwash
Participants assigned to this arm will receive a 10 ppm silver nanoparticle (AgNP) mouthwash.
They will rinse with 10 mL of the mouthwash for 60 seconds twice daily (morning and evening) for 14 consecutive days.
Participants will be instructed to avoid eating or drinking for 30 minutes after each rinse while maintaining their routine oral hygiene practices.
|
Participants assigned to the experimental group will receive a 10 ppm silver nanoparticle (AgNP) mouthwash.
They will rinse with 10 mL of the mouthwash for 60 seconds twice daily (morning and evening) after toothbrushing for 14 consecutive days.
Participants will be instructed not to eat or drink for 30 minutes after each rinse and to maintain their usual oral hygiene practices throughout the study period.
|
|
Comparador Ativo: Chlorhexidine Mouthwash
Participants assigned to this arm will receive a 0.2% chlorhexidine gluconate mouthwash.
They will rinse with 10 mL of the mouthwash for 60 seconds twice daily (morning and evening) for 14 consecutive days.
Participants will be instructed to avoid eating or drinking for 30 minutes after each rinse while maintaining their routine oral hygiene practices.
|
Participants assigned to the active comparator group will receive a 0.2% chlorhexidine gluconate mouthwash.
They will rinse with 10 mL of the mouthwash for 60 seconds twice daily (morning and evening) after toothbrushing for 14 consecutive days.
Participants will be instructed not to eat or drink for 30 minutes after each rinse and to maintain their usual oral hygiene practices throughout the study period.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in salivary Streptococcus mutans levels
Prazo: Baseline and Day 14
|
Salivary Streptococcus mutans levels will be quantified as log10 colony-forming units per milliliter (log10 CFU/mL) using microbiological culture methods.
The primary endpoint is the change from baseline to Day 14 following completion of the assigned mouthwash intervention.
|
Baseline and Day 14
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 17-2026-0004
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .