Dental CariesNCT03802669
Molecular Assessment of Oral Mutans Streptococcus Isolated From Different Patients
An observational study of Dental Caries, run by October University for Modern Sciences and Arts at 1 site in Egypt.
Trial summary
90 saliva samples will be isolated from patient who possess different ages and caries activity, attending outpatient clinic of October University of Modern Sciences and Arts. Then the determination of the best selective media for mutans streptococcus isolated from saliva and authenticate the MS via PCR technique. Read more about this study
- Who is it for?
- Ages 3 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- oral mutans streptococcus
- Type of treatment
- Pill or oral medicine
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jan 2019to 20 May 2019
- 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 3 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: patients attending out patient clinic of October University for Modern Sciences and Arts.
Who may be able to join
- healthy participant
Who cannot join
- participant received antimicrobial therapy in previous month.
- participant who taking xylitol chewing gum or undergo fluoride therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Molecular Assessment of Oral Mutans Streptococcus Isolated From Patients With Different Age and Caries Activity Via Selective Media and Protein Pattern.
90 saliva samples will be isolated from patient who possess different ages and caries activity, attending outpatient clinic of October University of Modern Sciences and Arts. Then the determination of the best selective media for mutans streptococcus isolated from saliva and authenticate the MS via PCR technique.
- Conditions
- Dental Caries
- Being tested
- oral mutans streptococcus
- Keywords
- human saliva, mutans streptococcus, PCR, caries activity
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral mutans streptococcusOther
quantitative assessment of mutans streptococcus of each group by using PCR and protein pattern
| Study group | Role | What they receive |
|---|---|---|
| caries free children aged between 3-6 | Not described Receives: Other: oral mutans streptococcus | |
| caries active children aged between 3-6 | Not described Receives: Other: oral mutans streptococcus | |
| caries free children aged between 6-12 | Not described Receives: Other: oral mutans streptococcus | |
| caries active children aged between 6-12 | Not described Receives: Other: oral mutans streptococcus | |
| caries free adult aged between 18-25 | Not described Receives: Other: oral mutans streptococcus | |
| caries active adult aged between 18-25 | Not described Receives: Other: oral mutans streptococcus |
What is being measured
The primary outcome is the main question the study is designed to answer.
oral mutans streptococcus screening
screening of oral mutans streptococcus of each group to determine the differences
Measured: immediately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start12 Jan 2019
- Primary completion15 Feb 2019
- Study completion20 May 2019
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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- October University for Modern Sciences and Arts
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naglaa Ibrahim Ezz, October University for Modern Sciences and Arts
- Investigators
- Naglaa Ezzeldin, lecturer, Principal investigator, October University for Modern Sciences and Arts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03802669
- Sponsor's protocol ID
- ETH10
- Status last verified
- Sep 2019
- First submitted
- 10 Jan 2019
- Last updated
- 17 Sep 2019
- Results posted
- No
- 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 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Assessment of Oral Mutans Streptococcus Isolated From Patients With Different Age and Caries Activity Via Selective Media and Protein Pattern.
- ClinicalTrials.gov ID
- NCT03802669
- Acronym / sponsor ID
- ETH10
- Conditions
- Dental Caries
- Keywords
- human saliva, mutans streptococcus, PCR, caries activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- October University for Modern Sciences and ArtsUniversity, hospital or other
- Study start
- 12 Jan 2019 (actual)
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 20 May 2019 (actual)
- First posted
- 14 Jan 2019 (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.
90 saliva samples will be isolated from patient who possess different ages and caries activity, attending outpatient clinic of October University of Modern Sciences and Arts. Then the determination of the best selective media for mutans streptococcus isolated from saliva and authenticate the MS via PCR technique.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| caries free children aged between 3-6 | – | Other: oral mutans streptococcus |
| caries active children aged between 3-6 | – | Other: oral mutans streptococcus |
| caries free children aged between 6-12 | – | Other: oral mutans streptococcus |
| caries active children aged between 6-12 | – | Other: oral mutans streptococcus |
| caries free adult aged between 18-25 | – | Other: oral mutans streptococcus |
| caries active adult aged between 18-25 | – | Other: oral mutans streptococcus |
Who may qualify
- Ages
- 3 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- patients attending out patient clinic of October University for Modern Sciences and Arts.
Key inclusion criteria (1 listed)
- healthy participant
Key exclusion criteria (2 listed)
- participant received antimicrobial therapy in previous month.
- participant who taking xylitol chewing gum or undergo fluoride therapy.
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 |
|---|---|---|
| oral mutans streptococcusquantitative assessment of mutans streptococcus of each group by using PCR and protein pattern | Other | caries active adult aged between 18-25, caries active children aged between 3-6, caries active children aged between 6-12, caries free adult aged between 18-25, caries free children aged between 3-6, caries free children aged between 6-12 |
Primary outcome
oral mutans streptococcus screening
Time frame: immediately
screening of oral mutans streptococcus of each group to determine the differences
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 17 Sep 2019.
- 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.
Naglaa Ezzeldin, lecturer principal investigator
October University for Modern Sciences and Arts
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries, run by October University for Modern Sciences and Arts 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 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: finished, as of the sponsor's last update on 17 Sep 2019. 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?
oral mutans streptococcus screening (time frame: immediately). 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 17 Sep 2019.