A Randomized Clinical Trial Comparing Silver Nanoparticle and Chlorhexidine Mouthwashes on Streptococcus Mutans Levels and Salivary pH in Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 96
- 主要终点
- Change in salivary Streptococcus mutans levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 6 Years 至 12 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Silver nanoparticle mouthwash (10 ppm) (Drug)
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.
干预措施: Chlorhexidine mouthwash (0.2%) (Drug)
结局指标
主要结局
Change in salivary Streptococcus mutans levels
时间窗: 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.
次要结局
未报告次要终点
研究者
ِAhmed kamel Abdel Naser soliman
Assistant Lecturer
Assiut University
