Early Childhood CariesNCT04218955
Parental Acceptance and Perception of Silver Diamine FlouridApplication Among A Sample of Egyptian Children.
An observational study of Early Childhood Caries, run by Cairo University.
Trial summary
Dental caries can be prevented or arrested . Moreover, preventive measures for dental caries are more cost effective than emergency room visits or restorative treatments when the illness has been established . One of the recent preventive methods of dental caries is silver diamine flouride . Read more about this study
- Who is it for?
- Ages 1 year to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Early Childhood Caries
- What is being tested?
- Silver Diamine Flouride
- How many people
- 320 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2020to 1 Mar 2021
- Phase
- Observational
- 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 1 year to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Parents whose children have early childhood caries seeking for dental treatment coming to the outpatient diagnostic clinics in the department of pediatric dentistry, Cairo University, Egypt.
Who may be able to join
- parents whose children with early childhood caries. Accepting participations.
Who cannot join
- Refusal of participation.
Trial locations and contacts
No sites are listed yet.
Gihan Abu El Neil, Ass. prof contact
About this study
Official title: Parental Acceptance and Perception of Silver Diamine Flouride Application Among A Sample of Egyptian Children
Dental caries can be prevented or arrested . Moreover, preventive measures for dental caries are more cost effective than emergency room visits or restorative treatments when the illness has been established . One of the recent preventive methods of dental caries is silver diamine flouride . SDF has been used as an alternative treatment for caries prevention and arrest . Several studies showed that silver diamine flouride cause staining of the treated teeth . However, parents have different attitudes toward using SDF considering its positives and negatives.
Read the detailed description
Dental caries is one of the most common diseases in the world, with a prevalence of 69%-79% . Early childhood caries (ECC) has been recognized by the American Dental Association as an important public health issue and was defined as presence of 1 or more decayed, missing, or filled tooth surfaces (dmfs) in any primary tooth in a preschool-aged child . Caries was known to be managed through two main approaches: Treatment, which includes drill and fill which is a challenge specially in minimally cooperative children and the second approach is prevention which depends on cease the process of caries formation at an early stage which is more effective . One of the recently marketed preventive measures of dental caries is silver diamine fluoride (SDF) .
In 2014, SDF was approved by the US Food and Drug Administration as a treatment for dentinal sensitivity .It was proven to be a cost-effective, minimally invasive, and handy treatment . Silver diamine flouride is easy to apply in a minimally cooperative individual . More important, it has shown a noticeable success rate in caries prevention, especially in early childhood caries cases . It provides families with an alternative solutions for managing dental caries, particularly if caries was detected at an early stage . Moreover, it could save time and effort for both families and dental teams.
The major downside of SDF is the unesthetic permanent black discoloration of the arrested lesion , which could affect parental acceptance for the treatment and may result in shifting to another esthetically acceptable treatment.
- Conditions
- Early Childhood Caries
- Being tested
- Silver Diamine Flouride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver Diamine FlourideCombination product
Material used to arrest caries in children
| Study group | Role | What they receive |
|---|---|---|
| 1 | Asking parents if they can accept staining from treat their children by silver Diamine Flouride or Not Receives: Combination Product: Silver Diamine Flouride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental Satisfication about treat their children with silver Diamine flouride
Using Likert scale ranging from Strong Accept ,Accept ,Neutral, Refuse, Strong Refuse.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start1 Jan 2020 (estimated)
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Childhood CariesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Mohamed Abd El Aziz Waly, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218955
- Sponsor's protocol ID
- Parental acceptance of SDF
- Status last verified
- Dec 2019
- First submitted
- 27 Dec 2019
- Last updated
- 6 Jan 2020
- 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 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parental Acceptance and Perception of Silver Diamine Flouride Application Among A Sample of Egyptian Children
- ClinicalTrials.gov ID
- NCT04218955
- Acronym / sponsor ID
- Parental acceptance of SDF
- Conditions
- Early Childhood Caries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 6 Jan 2020 (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.
Dental caries can be prevented or arrested . Moreover, preventive measures for dental caries are more cost effective than emergency room visits or restorative treatments when the illness has been established . One of the recent preventive methods of dental caries is silver diamine flouride . SDF has been used as an alternative treatment for caries prevention and arrest . Several studies showed that silver diamine flouride cause staining of the treated teeth . However, parents have different attitudes toward using SDF considering its positives and negatives.
Detailed description
Dental caries is one of the most common diseases in the world, with a prevalence of 69%-79% . Early childhood caries (ECC) has been recognized by the American Dental Association as an important public health issue and was defined as presence of 1 or more decayed, missing, or filled tooth surfaces (dmfs) in any primary tooth in a preschool-aged child . Caries was known to be managed through two main approaches: Treatment, which includes drill and fill which is a challenge specially in minimally cooperative children and the second approach is prevention which depends on cease the process of caries formation at an early stage which is more effective . One of the recently marketed preventive measures of dental caries is silver diamine fluoride (SDF) .
In 2014, SDF was approved by the US Food and Drug Administration as a treatment for dentinal sensitivity .It was proven to be a cost-effective, minimally invasive, and handy treatment . Silver diamine flouride is easy to apply in a minimally cooperative individual . More important, it has shown a noticeable success rate in caries prevention, especially in early childhood caries cases . It provides families with an alternative solutions for managing dental caries, particularly if caries was detected at an early stage . Moreover, it could save time and effort for both families and dental teams.
The major downside of SDF is the unesthetic permanent black discoloration of the arrested lesion , which could affect parental acceptance for the treatment and may result in shifting to another esthetically acceptable treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Combination Product: Silver Diamine FlourideAsking parents if they can accept staining from treat their children by silver Diamine Flouride or Not |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Parents whose children have early childhood caries seeking for dental treatment coming to the outpatient diagnostic clinics in the department of pediatric dentistry, Cairo University, Egypt.
Key inclusion criteria (1 listed)
- parents whose children with early childhood caries. Accepting participations.
Key exclusion criteria (1 listed)
- Refusal of participation.
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 |
|---|---|---|
| Silver Diamine FlourideMaterial used to arrest caries in children | Combination product | 1 |
Primary outcome
Parental Satisfication about treat their children with silver Diamine flouride
Time frame: Baseline
Using Likert scale ranging from Strong Accept ,Accept ,Neutral, Refuse, Strong Refuse.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
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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.
Gihan Abu El Neil, Ass. prof contact
Questions about this trial
What is this clinical trial studying?
An observational study of Early Childhood Caries, 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 1 inclusion and 1 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 6 Jan 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mostafa Waly (01273581262, Mostafa.AbdalAziz@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental Satisfication about treat their children with silver Diamine flouride (time frame: Baseline). 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 6 Jan 2020.