El Paso Public Health Biorepository (EPB)

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: Oral Disease; Bacterial Disease

Detailed Description

As per summary above.

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• United States
  • Texas
    • El Paso, Texas, United States, 79905
      • Texas Tech University Health Sciences Center El Paso

Participation Criteria

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

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	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	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

• Sponsor: Texas Tech University Health Sciences Center, El Paso
• Collaborators: The City of El Paso Department of Public Health
• Investigators: Principal Investigator: Peter S Rotwein, M.D., Texas Tech University Health Sciences Center, El Paso

Study record dates

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: Infections; Stomatognathic Diseases; Bacterial Infections and Mycoses; Mouth Diseases; Bacterial Infections
• 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