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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Comparateur actif: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in salivary Streptococcus mutans levels
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 17-2026-0004
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .