Oral DiseaseEPBNCT03123705
El Paso Public Health Biorepository
An observational study of Oral Disease and Bacterial Disease, run by Texas Tech University Health Sciences Center, El Paso at 1 site in United States.
Trial summary
The prevalence of tooth decay and other oral diseases are overlooked indicators of overall public health. To improve the understanding of oral health in El Paso, the City of El Paso Health Department will work with Texas Tech University Health Sciences Center at El Paso to determine factors that contribute to poor… Read more about this study
- Who is it for?
- Ages 10 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Disease, Bacterial Disease
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2017to 30 Sep 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 10 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Male and female patients between the ages of 10-21.
Who may be able to join
- Individuals seen at the City of El Paso dental or pediatric clinics ages 10-21
- Healthy children and patients that are likely to be seen in the clinics within the predetermined follow-up time of 6 months
Who cannot join
- Patients under 10 years of age and over 21 years of age.
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University Health Sciences Center El Paso
El Paso, Texas, 79905
About this study
Official title: TTUHSC El Paso Public Health Biorepository (Research Core Laboratories Dental Biorepository)
The prevalence of tooth decay and other oral diseases are overlooked indicators of overall public health. To improve the understanding of oral health in El Paso, the City of El Paso Health Department will work with Texas Tech University Health Sciences Center at El Paso to determine factors that contribute to poor oral health, and lead to cavities and periodontitis. The team will collect saliva from children and young adults to study oral infections, markers of inflammation, and other contributors to oral illnesses in Mexican-American individuals.
Read the detailed description
As per summary above.
- Conditions
- Oral Disease, Bacterial Disease
- Medical subject headings
- Mouth Diseases, Bacterial Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Creation of saliva bio-repository
Saliva will be collected from dental patients to be stored for research
Measured: Through study completion, an average of 3 years
The study of oral bacteria
DNA of samples will be analyzed to determine if bacteria play a role in oral health
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start26 May 2017
- Primary completion31 Aug 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center, El Paso
- Sponsor type
- University, hospital or other
- Collaborators
- The City of El Paso Department of Public Health
- Responsible party
- Principal investigator, Peter Rotwein, Texas Tech University Health Sciences Center, El Paso
- Investigators
- Peter S Rotwein, M.D., Principal investigator, Texas Tech University Health Sciences Center, El Paso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03123705
- Sponsor's protocol ID
- E16076
- Acronym
- EPB
- Status last verified
- Oct 2019
- First submitted
- 13 Apr 2017
- Last updated
- 28 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified information and tissue and body fluid samples will be made available to collaborating academic institutions through material transfer agreements.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TTUHSC El Paso Public Health Biorepository (Research Core Laboratories Dental Biorepository)
- ClinicalTrials.gov ID
- NCT03123705
- Acronym / sponsor ID
- EPB / E16076
- Conditions
- Oral Disease, Bacterial Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences Center, El PasoUniversity, hospital or other
- Collaborators
- The City of El Paso Department of Public Health
- Study start
- 26 May 2017 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 21 Apr 2017 (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.
The prevalence of tooth decay and other oral diseases are overlooked indicators of overall public health. To improve the understanding of oral health in El Paso, the City of El Paso Health Department will work with Texas Tech University Health Sciences Center at El Paso to determine factors that contribute to poor oral health, and lead to cavities and periodontitis. The team will collect saliva from children and young adults to study oral infections, markers of inflammation, and other contributors to oral illnesses in Mexican-American individuals.
Detailed description
As per summary above.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Male and female patients between the ages of 10-21.
Key inclusion criteria (2 listed)
- Individuals seen at the City of El Paso dental or pediatric clinics ages 10-21
- Healthy children and patients that are likely to be seen in the clinics within the predetermined follow-up time of 6 months
Key exclusion criteria (1 listed)
- Patients under 10 years of age and over 21 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Creation of saliva bio-repository
Time frame: Through study completion, an average of 3 years
Saliva will be collected from dental patients to be stored for research
The study of oral bacteria
Time frame: Through study completion, an average of 3 years
DNA of samples will be analyzed to determine if bacteria play a role in oral health
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 28 Oct 2019.
- Individual participant dataSharing planned: Yes. De-identified information and tissue and body fluid samples will be made available to collaborating academic institutions through material transfer agreements.
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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.
Peter S Rotwein, M.D. principal investigator
Texas Tech University Health Sciences Center, El Paso
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 Oral Disease and Bacterial Disease, run by Texas Tech University Health Sciences Center, El Paso at 1 site in United States.
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 2 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: finished, as of the sponsor's last update on 28 Oct 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 United States. 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?
Creation of saliva bio-repository (time frame: Through study completion, an average of 3 years). 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 28 Oct 2019.