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Silver Nanoparticle vs Chlorhexidine Mouthwashes for Reducing Streptococcus Mutans and Improving Salivary pH in Children (SMILE)

25 luglio 2026 aggiornato da: ِAhmed kamel Abdel Naser soliman, Assiut University

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.

Panoramica dello studio

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

96

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino

Accetta volontari sani

Sì

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comparatore attivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in salivary Streptococcus mutans levels
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

5 agosto 2026

Completamento primario (Stimato)

20 settembre 2026

Completamento dello studio (Stimato)

20 ottobre 2026

Date di iscrizione allo studio

Primo inviato

22 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

22 luglio 2026

Primo Inserito (Effettivo)

27 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

28 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 17-2026-0004

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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