Silver Nanoparticle vs Chlorhexidine Mouthwashes for Reducing Streptococcus Mutans and Improving Salivary pH in Children | NCT07728409

NCT07728409

Overview

NCT ID: NCT07728409
Lead Sponsor: Assiut UniversityOTHER
Official Title: A Randomized Clinical Trial Comparing Silver Nanoparticle and Chlorhexidine Mouthwashes on Streptococcus Mutans Levels and Salivary pH in Pediatric Patients
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

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 28, 2026Actual
Start Date: Aug 5, 2026Estimated
Primary Completion Date: Sep 20, 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: 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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 96Estimated
Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Contacts and Locations

Central Contacts: No data available
Locations: No data available

Similar Studies

Participant Group/Arms

Silver Nanoparticle MouthwashExperimental

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 MouthwashActive 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%)