Teeth StainingNCT07200063
Children Acceptance of AgNP Mouthwash Against Chlorhexidine 0.12% and Chlorhexidine .2% Mouthwashs
A study testing nano silver mouthwash, Chlorhexidine mouthwash (0.12%) and Chlorhexidine mouthwash (0.2%) in people with Teeth Staining and Numbness of the Tongue and Soft Tissue, run by Cairo University.
Trial summary
This study aims to evaluate and compare the children's acceptance of mouthwash containing silver nanoparticles versus Chlorhexidine 0.12% \& Chlorhexidine 0.2% Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Teeth Staining, Numbness of the Tongue and Soft Tissue, Bitter Taste
- What is being tested?
- nano silver mouthwash, Chlorhexidine mouthwash (0.12%) and Chlorhexidine mouthwash (0.2%)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Children who are unable to attend the follow-up visit
- Medically compromised patient
- Handi-capped patient
- Parents refuse to sign informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Assessment of Children's Acceptance of Mouthwash Containing Silver Nanoparticles Compared to Chlorhexidine 0.12% &Chlorhexidine 0.2% Mouthwashs: A Randomized Clinical Trial.
This study aims to evaluate and compare the children's acceptance of mouthwash containing silver nanoparticles versus Chlorhexidine 0.12% \& Chlorhexidine 0.2%
Read the detailed description
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.
- Being tested
- nano silver mouthwash, Chlorhexidine mouthwash (0.12%), Chlorhexidine mouthwash (0.2%)
- Medical subject headings
- Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nano silver mouthwashOther
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
Also called orovex
chlorhexidine mouthwash 0.2% (orovex )
| Study group | Role | What they receive |
|---|---|---|
| use AgNP mouthwash as experimental group | Experimental | nano cure mouthwash Receives: Other: nano silver mouthwash |
| use hexitol mouthwash (CHX) as experimental group | Experimental | Not described Receives: Other: Chlorhexidine mouthwash (0.12%) |
| orovex mouthwash (CHX) as a comparator group | Active comparator | Not described Receives: Other: Chlorhexidine mouthwash (0.2%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
children acceptance
it will be assessed by (yes OR no ) survey (Binary outcome )
Measured: 15 days
Secondary outcomes (2)
Gingival health
- gingival inflammation measured by modified gingival index scoring criteria (0-4) 0 (Normal gingiva ) 4 (sever inflammation of gingiva)
Measured: 15 days
plaque thickness at gingival margin
- measure plaque thickness at gingival margin by plaque index by loe and silness scoring criteria (0-3) 0 (no plaque) 3 (thick plaque)
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study startJan 2027 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Teeth StainingStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized clinical trail on three groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahem Mohamed Ibrahem Arafat, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07200063
- Sponsor's protocol ID
- AgNP vs CHX Mouthwashes
- Status last verified
- Oct 2026
- First submitted
- 9 Sep 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: cause it a private data and it's mentioned in the informed consent that the data of the participants will be private and not published
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Assessment of Children's Acceptance of Mouthwash Containing Silver Nanoparticles Compared to Chlorhexidine 0.12% &Chlorhexidine 0.2% Mouthwashs: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT07200063
- Acronym / sponsor ID
- AgNP vs CHX Mouthwashes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate and compare the children's acceptance of mouthwash containing silver nanoparticles versus Chlorhexidine 0.12% \& Chlorhexidine 0.2%
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- randomized clinical trail on three groups
| Arm | Type | Receives |
|---|---|---|
| use AgNP mouthwash as experimental group | Experimental | Other: nano silver mouthwashnano cure mouthwash |
| use hexitol mouthwash (CHX) as experimental group | Experimental | Other: Chlorhexidine mouthwash (0.12%) |
| orovex mouthwash (CHX) as a comparator group | Active comparator | Other: Chlorhexidine mouthwash (0.2%) |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Children who are unable to attend the follow-up visit
- Medically compromised patient
- Handi-capped patient
- Parents refuse to sign informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nano silver mouthwashnano silver mouthwash will reduce the side effect of chlorhexidine and increase acceptance of the mouthwash to patients | Other | use AgNP mouthwash as experimental group |
| Chlorhexidine mouthwash (0.12%)the concentration of chlorhexidine | Other | use hexitol mouthwash (CHX) as experimental group |
| Chlorhexidine mouthwash (0.2%)Also: orovexchlorhexidine mouthwash 0.2% (orovex ) | Other | orovex mouthwash (CHX) as a comparator group |
Primary outcome
children acceptance
Time frame: 15 days
it will be assessed by (yes OR no ) survey (Binary outcome )
2 secondary outcomes
Gingival health
Time frame: 15 days
plaque thickness at gingival margin
Time frame: 15 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No. cause it a private data and it's mentioned in the informed consent that the data of the participants will be private and not published
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing nano silver mouthwash, Chlorhexidine mouthwash (0.12%) and Chlorhexidine mouthwash (0.2%) in people with Teeth Staining and Numbness of the Tongue and Soft Tissue, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ibrahem mohamed Arafat (0201004769096, Ibrahem.arafat@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
children acceptance (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.