Dental CariesPreventionNCT06576960
Caries Inhibitory Effect of Nano Silver and Tri Calcium Phosphate Varnishes Among Visually Impaired Children
A study testing Nano silver fluoride varnish and tri calcium phosphate varnish in people with Dental Caries, run by Hadeer Mohammed Abd El wahab at 1 site in Egypt.
Trial summary
Assessment of pH,streptococcus mutants count, lactobacillus count and immunoglobulin A among visually impaired children after nano silver varnish application it tri calcium phosphate phosphate varnish application Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- Nano silver fluoride varnish and tri calcium phosphate varnish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Oct 2022to 13 Apr 2023
- Phase
- Interventional
- 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Visually impaired children
Who cannot join
- uncooperative children or children not willing to participate in the study.
- Children with systemic diseases
- Children with bronchial asthma.
- Children who were on antibiotic or medications that might affect oral flora or salivary flow taken within the previous 3 months
- History of fluoride treatment in the past 3-4 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Caries Inhibitory Effect of Nano Silver Varnish Versus Tri Calcium Phosphate Varnish Among Children With Visual Impairment
Assessment of pH,streptococcus mutants count, lactobacillus count and immunoglobulin A among visually impaired children after nano silver varnish application it tri calcium phosphate phosphate varnish application
Read the detailed description
Sixty children will be randomly divided into three equal treatment groups, composed of 20 children each, according to the type of material used as follows:
- Group I: children will receive oral health education and nano silver fluoride varnish.
- Group II: children will receive oral health education and tri calcium phosphate varnish.
- Group III: children will receive oral health education for all children ,Assessment of pH, streptococcus mutants count, lactobacillus count and immunoglobulin A will be assessed at baseline, one day , 3 months and 6 months after application
- Conditions
- Dental Caries
- Being tested
- Nano silver fluoride varnish and tri calcium phosphate varnish
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nano silver fluoride varnish and tri calcium phosphate varnishDrug
Also called health education
Fluoride varnishes
| Study group | Role | What they receive |
|---|---|---|
| nano silver varnish | Experimental | new fluoride varnish Receives: Drug: Nano silver fluoride varnish and tri calcium phosphate varnish |
| tri calcium phosphate varnish | Experimental | fluoride varnish contain calcium phosphate Receives: Drug: Nano silver fluoride varnish and tri calcium phosphate varnish |
| health education | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary PH
Salivary power of hydrogen at baseline, one month, 3months and six months after intervention
Measured: 6 months
Salivary streptococcus mutants count
Count of bacteria at baseline, one day, 3months and six months after intervention
Measured: 6months
Lactobacillus count
Count of bacteria at baseline, one day, 3months and six months after intervention
Measured: 6 months
Immunoglobulin A
Level of immunoglobulin A at saliva at baseline, one day, 3months and 6 months after intervention
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start11 Oct 2022
- Primary completion11 Apr 2023
- Study completion13 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadeer Mohammed Abd El wahab
- Sponsor type
- University, hospital or other
- Collaborators
- Tanta University
- Responsible party
- Sponsor-investigator, Hadeer Mohammed Abd El wahab, Tanta University
- Investigators
- Hatem Amin, PhD, Study director, Faculty of dentistry . Tanta university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576960
- Sponsor's protocol ID
- OH12-12
- Acronym
- Prevention
- Status last verified
- Aug 2024
- First submitted
- 26 Aug 2024
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caries Inhibitory Effect of Nano Silver Varnish Versus Tri Calcium Phosphate Varnish Among Children With Visual Impairment
- ClinicalTrials.gov ID
- NCT06576960
- Acronym / sponsor ID
- Prevention / OH12-12
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hadeer Mohammed Abd El wahabUniversity, hospital or other
- Collaborators
- Tanta University
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- 11 Apr 2023 (actual)
- Study completion
- 13 Apr 2023 (actual)
- First posted
- 29 Aug 2024 (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.
Assessment of pH,streptococcus mutants count, lactobacillus count and immunoglobulin A among visually impaired children after nano silver varnish application it tri calcium phosphate phosphate varnish application
Detailed description
Sixty children will be randomly divided into three equal treatment groups, composed of 20 children each, according to the type of material used as follows:
- Group I: children will receive oral health education and nano silver fluoride varnish.
- Group II: children will receive oral health education and tri calcium phosphate varnish.
- Group III: children will receive oral health education for all children ,Assessment of pH, streptococcus mutants count, lactobacillus count and immunoglobulin A will be assessed at baseline, one day , 3 months and 6 months after application
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| nano silver varnish | Experimental | Drug: Nano silver fluoride varnish and tri calcium phosphate varnishnew fluoride varnish |
| tri calcium phosphate varnish | Experimental | Drug: Nano silver fluoride varnish and tri calcium phosphate varnishfluoride varnish contain calcium phosphate |
| health education | No intervention | – |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Visually impaired children
Key exclusion criteria (5 listed)
- uncooperative children or children not willing to participate in the study.
- Children with systemic diseases
- Children with bronchial asthma.
- Children who were on antibiotic or medications that might affect oral flora or salivary flow taken within the previous 3 months
- History of fluoride treatment in the past 3-4 weeks.
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 fluoride varnish and tri calcium phosphate varnishAlso: health educationFluoride varnishes | Drug | nano silver varnish, tri calcium phosphate varnish |
Primary outcome
Salivary PH
Time frame: 6 months
Salivary power of hydrogen at baseline, one month, 3months and six months after intervention
Salivary streptococcus mutants count
Time frame: 6months
Count of bacteria at baseline, one day, 3months and six months after intervention
Lactobacillus count
Time frame: 6 months
Count of bacteria at baseline, one day, 3months and six months after intervention
Immunoglobulin A
Time frame: 6months
Level of immunoglobulin A at saliva at baseline, one day, 3months and 6 months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Hatem Amin, PhD study director
Faculty of dentistry . Tanta university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nano silver fluoride varnish and tri calcium phosphate varnish in people with Dental Caries, run by Hadeer Mohammed Abd El wahab 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 29 Aug 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Salivary PH (time frame: 6 months). The study lists 4 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 29 Aug 2024.