Dental Caries in ChildrenPhase 1NCT05941429
Comparison of Cariostatic Effect of Nano-Silver Fluoride Versus Silver Diamine Fluoride
A Phase 1 study testing Nano-Silver Fluoride and Silver diamine fluoride in people with Dental Caries in Children, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to test the cariostatic effect of Nano Silver Fluoride in a comparison to Silver Diamine Fluoride in a group of preschool children. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- Nano-Silver Fluoride and Silver diamine fluoride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Feb 2024to Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged from 3 to 5 years
- clinical diagnosis of active dentinal caries in primary teeth
- Co-operative participants and free of any systemic diseases
Who cannot join
- Children whose parents refuse to sign consent
- Primary teeth with pulp involvement, pain, mobility, abscess, sinus, fistula; or discoloration related to tooth non-vitality.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Cariostatic Effect of Nano-Silver Fluoride Versus Silver Diamine Fluoride in a Group of Preschool Children
This study will be conducted to test the cariostatic effect of Nano Silver Fluoride in a comparison to Silver Diamine Fluoride in a group of preschool children.
Read the detailed description
Silver Diamine Fluoride has offered a non-invasive and easily performed method to manage dental caries in very young children.Studies shows that SDF has been proven to arrest caries in cavitated lesions and to prevent caries in sound teeth as Fluoride is effective in enhancing the remineralization of dental hard tissue and silver ion acts as an antibacterial agent. However, It was found that silver causes staining to the dental tissues with a black discoloration, which can be considered to be a main drawback specifically, when it is used on anterior teeth. Nano-silver fluoride varnish preparation showed high efficacy in arresting caries progression in primary teeth without causing black discoloration to the tissues.Silver diamine fluoride (SDF) .
Benefits for patient:
- Non-invasive treatment leading to reduce patient anxiety and stress.
- No drilling and filling.
- Protects against further caries progression.
Benefits for the practitioner:
- Provide alternative treatment options.
- Pain-free procedure that facilitates child management and saves time.
Benefits for the community:
- Increasing overall oral health
- Provides more information by testing new material
- To provide better service quality.
- Conditions
- Dental Caries in Children
- Being tested
- Nano-Silver Fluoride, Silver diamine fluoride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nano-Silver FluorideDrug
Also called NSF
NSF is a varnish which has been introduced as experimental formulation . the laboratory synthesis of NSF was carried out in a nano techonolgy center .
Silver diamine fluorideDrug
Also called SDF
38% silver diamine fluoride
| Study group | Role | What they receive |
|---|---|---|
| Silver Diamine Fluoride | Active comparator | 38% Silver Diamine Fluoride varnish
1. the affected tooth will be cleaned by a disposable micro-brush for 30 seconds and then will be dried using cotton gauze sponges.
2. No excavation will be done to the infected dentin tissue prior to the application of the agent.
3. Gum will be protected with petroleum jelly, and isolation will be achieved by using cotton rolls.
4. After isolation, a single drop SDF will be applied into the cavity by using a disposable micro-brush for at least two minutes. Then site of application will be covered with petroleum jelly.
5. Finally, parents will be instructed that children participating in the trial are not allowed to eat or drink for one hour after application of the agent Receives: Drug: Silver diamine fluoride |
| Nano-Silver Fluoride | Experimental | Nano-Silver fluoride varnish preparation
1. the affected tooth will be cleaned by a disposable micro-brush for 30 seconds and then will be dried using cotton gauze sponges.
2. No excavation will be done to the infected dentin tissue prior to the application of the agent.
3. Gum will be protected with petroleum jelly, and isolation will be achieved by using cotton rolls.
4. After isolation, a single drop NSF will be applied into the cavity by using a disposable micro-brush for at least two minutes. Then site of application will be covered with petroleum jelly.
5. Finally, parents will be instructed that children participating in the trial are not allowed to eat or drink for one hour after application of the agent Receives: Drug: Nano-Silver Fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
caries lesion activity and severity assessment using Nyvad criteria
visual and tactile assessment for caries lesion to evaluate the caries progression using Nyvad classification - score from 0 ( normal enamel translucency and texture ) to 9 (carie lesion with filling )
Measured: baseline
caries lesion activity and severity assessment using Nyvad criteria
visual and tactile assessment for caries lesion to evaluate the caries progression using Nyvad classification - score from 0 ( normal enamel translucency and texture ) to 9 (carie lesion with filling )
Measured: 3 weeks
caries lesion activity and severity assessment using Nyvad criteria
visual and tactile assessment for caries lesion to evaluate the caries progression using Nyvad classification - score from 0 ( normal enamel translucency and texture ) to 9 (carie lesion with filling )
Measured: 6 months
Secondary outcomes (3)
ICDAS II
Detection and assessment of dental caries using ICDAS II - assessment done by photographs - score from 0 ( sound ) to 6 ( Extensive cavity with visible dentin )
Measured: baseline
ICDAS II
Detection and assessment of dental caries using ICDAS II - assessment done by photographs - score from 0 ( sound ) to 6 ( Extensive cavity with visible dentin )
Measured: 3 weeks
ICDAS II
Detection and assessment of dental caries using ICDAS II - assessment done by photographs - score from 0 ( sound ) to 6 ( Extensive cavity with visible dentin )
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start7 Feb 2024
- Primary completionNov 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries in ChildrenStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lara Abdelmoniem Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941429
- Sponsor's protocol ID
- 14422021493714
- Status last verified
- Oct 2024
- First submitted
- 21 Jun 2023
- Last updated
- 16 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cariostatic Effect of Nano-Silver Fluoride Versus Silver Diamine Fluoride in a Group of Preschool Children
- ClinicalTrials.gov ID
- NCT05941429
- Acronym / sponsor ID
- 14422021493714
- Conditions
- Dental Caries in Children
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 12 Jul 2023 (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 will be conducted to test the cariostatic effect of Nano Silver Fluoride in a comparison to Silver Diamine Fluoride in a group of preschool children.
Detailed description
Silver Diamine Fluoride has offered a non-invasive and easily performed method to manage dental caries in very young children.Studies shows that SDF has been proven to arrest caries in cavitated lesions and to prevent caries in sound teeth as Fluoride is effective in enhancing the remineralization of dental hard tissue and silver ion acts as an antibacterial agent. However, It was found that silver causes staining to the dental tissues with a black discoloration, which can be considered to be a main drawback specifically, when it is used on anterior teeth. Nano-silver fluoride varnish preparation showed high efficacy in arresting caries progression in primary teeth without causing black discoloration to the tissues.Silver diamine fluoride (SDF) .
Benefits for patient:
- Non-invasive treatment leading to reduce patient anxiety and stress.
- No drilling and filling.
- Protects against further caries progression.
Benefits for the practitioner:
- Provide alternative treatment options.
- Pain-free procedure that facilitates child management and saves time.
Benefits for the community:
- Increasing overall oral health
- Provides more information by testing new material
- To provide better service quality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silver Diamine Fluoride | Active comparator | Drug: Silver diamine fluoride38% Silver Diamine Fluoride varnish 1. the affected tooth will be cleaned by a disposable micro-brush for 30 seconds and then will be dried using cotton gauze sponges. 2. No excavation will be done to the infected dentin tissue prior to the application of the agent. 3. Gum will be protected with petroleum jelly, and isolation will be achieved by using cotton rolls. 4. After isolation, a single drop SDF will be applied into the cavity by using a disposable micro-brush for at least two minutes. Then site of application will be covered with petroleum jelly. 5. Finally, parents will be instructed that children participating in the trial are not allowed to eat or drink for one hour after application of the agent |
| Nano-Silver Fluoride | Experimental | Drug: Nano-Silver FluorideNano-Silver fluoride varnish preparation 1. the affected tooth will be cleaned by a disposable micro-brush for 30 seconds and then will be dried using cotton gauze sponges. 2. No excavation will be done to the infected dentin tissue prior to the application of the agent. 3. Gum will be protected with petroleum jelly, and isolation will be achieved by using cotton rolls. 4. After isolation, a single drop NSF will be applied into the cavity by using a disposable micro-brush for at least two minutes. Then site of application will be covered with petroleum jelly. 5. Finally, parents will be instructed that children participating in the trial are not allowed to eat or drink for one hour after application of the agent |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged from 3 to 5 years
- clinical diagnosis of active dentinal caries in primary teeth
- Co-operative participants and free of any systemic diseases
Key exclusion criteria (2 listed)
- Children whose parents refuse to sign consent
- Primary teeth with pulp involvement, pain, mobility, abscess, sinus, fistula; or discoloration related to tooth non-vitality.
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 FluorideAlso: NSFNSF is a varnish which has been introduced as experimental formulation . the laboratory synthesis of NSF was carried out in a nano techonolgy center . | Drug | Nano-Silver Fluoride |
| Silver diamine fluorideAlso: SDF38% silver diamine fluoride | Drug | Silver Diamine Fluoride |
Primary outcome
caries lesion activity and severity assessment using Nyvad criteria
Time frame: baseline
visual and tactile assessment for caries lesion to evaluate the caries progression using Nyvad classification - score from 0 ( normal enamel translucency and texture ) to 9 (carie lesion with filling )
caries lesion activity and severity assessment using Nyvad criteria
Time frame: 3 weeks
visual and tactile assessment for caries lesion to evaluate the caries progression using Nyvad classification - score from 0 ( normal enamel translucency and texture ) to 9 (carie lesion with filling )
caries lesion activity and severity assessment using Nyvad criteria
Time frame: 6 months
visual and tactile assessment for caries lesion to evaluate the caries progression using Nyvad classification - score from 0 ( normal enamel translucency and texture ) to 9 (carie lesion with filling )
3 secondary outcomes
ICDAS II
Time frame: baseline
ICDAS II
Time frame: 3 weeks
ICDAS II
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nano-Silver Fluoride and Silver diamine fluoride in people with Dental Caries in Children, run by Cairo University at 1 site in Egypt.
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 2 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: status not confirmed, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
caries lesion activity and severity assessment using Nyvad criteria (time frame: baseline). The study lists 3 primary outcomes in all. 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 16 Oct 2024.