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

2026年7月25日 更新者:ِ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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (推定)

96

段階

  • 適用できない

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子

健康ボランティアの受け入れ

はい

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:防止
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
アクティブコンパレータ: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in salivary Streptococcus mutans levels
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年8月5日

一次修了 (推定)

2026年9月20日

研究の完了 (推定)

2026年10月20日

試験登録日

最初に提出

2026年7月22日

QC基準を満たした最初の提出物

2026年7月22日

最初の投稿 (実際)

2026年7月27日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月28日

QC基準を満たした最後の更新が送信されました

2026年7月25日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 17-2026-0004

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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