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NCT Number: NCT07200063

Children Acceptance of AgNP Mouthwash Against Chlorhexidine Mouthwash

This study aims to evaluate and compare the children's acceptance of mouthwash containing silver nanoparticles versus Chlorhexidine.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Effective management of dental plaque is crucial for preventing periodontal diseases, dental caries, and other oral health complications. Oral hygiene can be maintained through both chemical and mechanical methods. Chemical methods are particularly beneficial in situations where mechanical cleaning proves challenging. Mouthwashes represent a significant chemical strategy for controlling plaque. Among different types of mouthwashes, chlorhexidine is considered the gold standard due to its high efficacy against a broad spectrum of bacteria and its role in plaque management, which helps prevent periodontal diseases. However, it is important to note that chlorhexidine has several side effects, such as numbness, changes in taste perception, dental staining, and an unpleasant bitter taste.

In modern applications, nanotechnology is being utilized more frequently, especially with the integration of nanoparticle materials. Silver nanoparticles, in particular, are widely used in the medical field because of their remarkable antibacterial effects on oral biofilms associated with periodontal disease.

Therefore, this research aims to evaluate the children's acceptance of chlorhexidine mouthwash in children compared to a mouthwash containing silver nanoparticles, as well as to assess their respective impacts on gingivitis.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children aged from 6 to 12 in good general health and medically free
  • Cooperative patient who will care about attending the follow-up visit
  • Acceptance of the parents to sign the informed consent
  • Composite restoration on anterior teeth Exclusion criteria
  • Children who are unable to attend the follow-up visit
  • Medically compromised patient
  • Handi-capped patient
  • Parents refuse to sign informed consent

Treatment and study plan

nano silver mouthwash

Other

nano silver mouthwash will reduce the side effect of chlorhexidine and increase acceptance of the mouthwash to patients

Chlorhexidine mouthwash (0.12%)

Other

the concentration of chlorhexidine

Chlorhexidine mouthwash (0.2%)

Other

chlorhexidine mouthwash 0.2% (orovex )

Other names: orovex

Primary outcomes

  1. children acceptance and compliance

    Time frame: 15 days

    it will be measured by likert scale (1-5)

    1 (strongly disagree) 5 (strongly agree)

Secondary outcomes

  1. Gingival health

    Time frame: 15 days

    • gingival inflammation measured by modified gingival index scoring criteria (0-4) 0 (Normal gingiva ) 4 (sever inflammation of gingiva)
  2. plaque thickness at gingival margin

    Time frame: 15 days

    • measure plaque thickness at gingival margin by plaque index by loe and silness scoring criteria (0-3) 0 (no plaque) 3 (thick plaque)
  3. color stability of composite restoration of anterior teeth

    Time frame: 15 days

    measure color stability of composite restoration of anterior teeth ΔE* = √((L₂ - L₁)² + (a₂ - a₁)² + (b₂ - b₁)²

    Where:

    L* = Lightness (0 = black, 100 = white)

    • = Red-Green axis (positive = red, negative = green)
    • = Yellow-Blue axis (positive = yellow, negative = blue
    • L1, a1, b1 = before exposure
    • L2, a2, b2 = after exposure A higher ∆E means more discoloration.

Study contacts

Contact information is provided by the study sponsor or research team.

Ibrahem mohamed Arafat

CONTACT

[email protected]

0201004769096

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Comparative Assessment of Children's Acceptance and Compliance of Mouthwash Containing Silver Nanoparticles Compared to Chlorhexidine Mouthwash: A Randomized Clinical Trial.

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 30, 2025
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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