Dental CariesNCT04329858
the Antibacterial Effect of Zinc ,Silver and Fluoride
A study testing silver modified glass ionomer, zinc modified and conventional glass ionomer in people with Dental Caries, run by Cairo University.
Trial summary
natural teeth will be filled with the 3 different material then the dentin sample will be collected ,bacterial culture and elementary analysis will be done Read more about this study
- Who is it for?
- Ages 10 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- silver modified glass ionomer, zinc modified and conventional glass ionomer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2021to 15 Jul 2021
- 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 10 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- patient need teeth extraction for orthodontic treatment
Who cannot join
- carious teeth deciduous teeth
About this study
Official title: the Antibacterial Effect of Different Glass Ionomer Restoration Containing Zinc ,Silver and Fluoride Ion:in Situ Study
natural teeth will be filled with the 3 different material then the dentin sample will be collected ,bacterial culture and elementary analysis will be done
Read the detailed description
orthodontic patient with premolar indicated for extraction , teeth will restored with the different material 3 months before doing extraction
- Conditions
- Dental Caries
- Being tested
- silver modified glass ionomer, zinc modified, conventional glass ionomer
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
silver modified glass ionomerProcedure or surgery
occlusal cavity filled with silver modified
zinc modifiedProcedure or surgery
occlusal cavity filled with zinc modified
conventional glass ionomerProcedure or surgery
occlusal cavity filled with conventional glass ionomer
| Study group | Role | What they receive |
|---|---|---|
| conventional glass ionomer | Active comparator | Not described Receives: Procedure: conventional glass ionomer |
| zinc modified glass ionomer | Experimental | Not described Receives: Procedure: zinc modified |
| silver modified glass ionomer | Experimental | Not described Receives: Procedure: silver modified glass ionomer |
What is being measured
The primary outcome is the main question the study is designed to answer.
bacterial count
streptococcus mutant count by culture of dentin sample excavated from the tooth after restoration removal
Measured: 3months
elementary analysis of dentin
elementary analysis of dentin component excavated from the cavity after restoration removal to detect the change in tooth mineral
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start15 Jul 2021 (estimated)
- Primary completion15 Jul 2021 (estimated)
- Study completion15 Jul 2021 (estimated)
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina mounir elkady, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04329858
- Sponsor's protocol ID
- 6679
- Status last verified
- Mar 2020
- First submitted
- 17 Jul 2018
- Last updated
- 1 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Antibacterial Effect of Different Glass Ionomer Restoration Containing Zinc ,Silver and Fluoride Ion:in Situ Study
- ClinicalTrials.gov ID
- NCT04329858
- Acronym / sponsor ID
- 6679
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jul 2021 (estimated)
- Primary completion
- 15 Jul 2021 (estimated)
- Study completion
- 15 Jul 2021 (estimated)
- First posted
- 1 Apr 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.
natural teeth will be filled with the 3 different material then the dentin sample will be collected ,bacterial culture and elementary analysis will be done
Detailed description
orthodontic patient with premolar indicated for extraction , teeth will restored with the different material 3 months before doing extraction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| conventional glass ionomer | Active comparator | Procedure: conventional glass ionomer |
| zinc modified glass ionomer | Experimental | Procedure: zinc modified |
| silver modified glass ionomer | Experimental | Procedure: silver modified glass ionomer |
Who may qualify
- Ages
- 10 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- patient need teeth extraction for orthodontic treatment
Key exclusion criteria (1 listed)
- carious teeth deciduous teeth
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 modified glass ionomerocclusal cavity filled with silver modified | Procedure or surgery | silver modified glass ionomer |
| zinc modifiedocclusal cavity filled with zinc modified | Procedure or surgery | zinc modified glass ionomer |
| conventional glass ionomerocclusal cavity filled with conventional glass ionomer | Procedure or surgery | conventional glass ionomer |
Primary outcome
bacterial count
Time frame: 3months
streptococcus mutant count by culture of dentin sample excavated from the tooth after restoration removal
elementary analysis of dentin
Time frame: 3months
elementary analysis of dentin component excavated from the cavity after restoration removal to detect the change in tooth mineral
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing silver modified glass ionomer, zinc modified and conventional glass ionomer in people with Dental 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 1 Apr 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?
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?
bacterial count (time frame: 3months). The study lists 2 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 1 Apr 2020.