- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03123705
El Paso Public Health Biorepository (EPB)
October 24, 2019 updated by: Peter Rotwein, Texas Tech University Health Sciences Center, El Paso
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.
Study Overview
Status
Completed
Conditions
Detailed Description
As per summary above.
Study Type
Observational
Enrollment (Actual)
90
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
El Paso, Texas, United States, 79905
- Texas Tech University Health Sciences Center El Paso
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 21 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Male and female patients between the ages of 10-21.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients under 10 years of age and over 21 years of age.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Through study completion, an average of 3 years
|
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
|
Through study completion, an average of 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Peter S Rotwein, M.D., Texas Tech University Health Sciences Center, El Paso
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 26, 2017
Primary Completion (Actual)
August 31, 2019
Study Completion (Actual)
September 30, 2019
Study Registration Dates
First Submitted
April 13, 2017
First Submitted That Met QC Criteria
April 18, 2017
First Posted (Actual)
April 21, 2017
Study Record Updates
Last Update Posted (Actual)
October 28, 2019
Last Update Submitted That Met QC Criteria
October 24, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E16076
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
De-identified information and tissue and body fluid samples will be made available to collaborating academic institutions through material transfer agreements.
IPD Sharing Time Frame
Request for materials should be made after research observations are published in a peer reviewed journal.
IPD Sharing Access Criteria
Institutions studying disease processes in Hispanic populations
IPD Sharing Supporting Information Type
- Study Protocol
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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