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

NCT07728409 | Not Yet Recruiting

• 1 other identifier: 17-2026-0004
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Dental Caries Prevention

Keywords

Silver nanoparticles; Streptococcus mutans; Chlorhexidine

Outcome Measures

Primary Outcomes (1)

• Change in salivary Streptococcus mutans levels

  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

Study Arms (2)

Silver Nanoparticle Mouthwash

EXPERIMENTAL

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.

Drug: Silver nanoparticle mouthwash (10 ppm)

Chlorhexidine Mouthwash

ACTIVE COMPARATOR

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.

Drug: Chlorhexidine mouthwash (0.2%)

Interventions

Silver nanoparticle mouthwash (10 ppm) DRUG

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.

Silver Nanoparticle Mouthwash

Chlorhexidine mouthwash (0.2%) DRUG

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.

Chlorhexidine Mouthwash

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, parents, care providers, investigators, outcome assessors, and the study statistician will be blinded to treatment allocation. Silver nanoparticle and chlorhexidine mouthwashes will be dispensed in identical opaque bottles with matching appearance and labeling. Randomization codes will be generated by an independent individual and concealed until completion of data collection and primary statistical analyses unless emergency unblinding is required for participant safety.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 27, 2026
• Study Start: August 5, 2026
• Primary Completion: September 20, 2026
• Study Completion (Estimated): October 20, 2026
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share