Trans Oral Health Pilot Survey Consent

Please review the information below to find out more about the survey. Once you have you can continue to take the Survey

 

Title of research: Trans Oral Health Pilot Survey

Investigator and Department: Dr. James Sciote – Professor: Department of Orthodontics, Temple University Kornberg School of Dentistry

 

Why am I being invited to take part in this research?

We invite you to take part in a research survey study because you are over the age of 21, identify as MTF or FTM transgender and are either transitioning or have transitioned with the help of either hormone supplements and/or hormone blocking drugs.

 

What should I know about this research?

  • Cultural awareness during dental care of minority populations can be inadequate and may serve to perpetuate underserved oral health needs. In healthcare, equality among patient populations is important, regardless of race, socioeconomic status or gender. The transgender population is one that unfortunately tends to be overlooked, especially in dentistry. The lack of awareness can lead to non-optimal provision of oral healthcare. We invite your participation in this pilot survey so dentists can learn more about transgender oral health needs, to better serve the national community.
  • Completing the survey is up to you and you can choose not to take part for whatever reason.
  • If you complete the survey, and later change your mind, your information will be removed from study and this decision will not be held against you.
  • You can ask all the questions you want before you decide to participate by contacting the study investigators.

 

Who can I talk to about this research?

If you have questions, concerns, or complaints, or think the research has hurt you, contact the research team at Temple University, Kornberg School of Dentistry, Department of Orthodontics, 3223 North Broad Street, Philadelphia PA 19140. Please contact James Sciote, DDS, MS, PhD either by mail, email:jjs6@temple.edu or by phone: (215) 707-4620.

In addition this research has been reviewed and approved by the Temple University Institutional Review Board. You may talk with them at: (215) 707-3390 or e-mail them at: irb@temple.edu for any of the following:

  • Your questions, concerns, or complaints are not being answered by the research team.
  • You cannot reach the research team.
  • You want to talk to someone besides the research team.
  • You have questions about your rights as a research subject.
  • You want to get information or provide input about this research.

 

Why is this research being done?

Although the unique physical and psychological needs of the transgender community might be recognized by the dental profession there is a very finite and restricted data source to reveal oral health status and its effects on wellness. This study will be one of the first to assess oral health status in transgendered people in different geographic locations in the United States.

Some oral health conditions have sex specific predilection, including gum infections, nerve pain in face or jaws, bone conditions such as arthritis and abnormal growths located on the soft tissue linings of the inner cheeks, tongue or throat. In people being treated with hormone supplements or hormone blocking drugs, it is unknown if these drug treatments change the risk for development of such conditions. The study will be the first to specifically look at this question, by asking about; 1). Oral health status before versus after hormone supplementation or 2). Oral health status after hormone supplementation.

If the study determines that individuals are at risk for different types of oral conditions from hormone supplementation, this information will be communicated to dental health care workers through research report publications and professional meetings, to help provide better screening, diagnosis and treatment.

In order to obtain information regarding oral health status without an actual visit to a dental office where an examination can be conducted, the study will rely on self-reports conducted through the study survey, from subjects willing to participate in the research.  The questions include three surveys already in existence that are known to accurately determine an individual’s Oral Health and Well Being, Jaw Pain and Function Status, and Oral Cancer Risk Assessment. In this way, oral health status reports already routinely collected in the U.S. population, can also be known for the U.S. Trans population.

 

How long will I be in this research?

You will be in this research for about twenty minutes, while completing the online survey.

 

What happens if I agree to be in this research?

If you participate in this research, you will be asked to read and approve this informed consent document, and then complete a twenty part oral health survey. When completed, the survey will be saved to a web address located at the Temple University Dental School in Philadelphia. This will complete the research study. You will have the option to save an incomplete survey and enter additional information later, before completing. You will not be interacting with the research team, or any other individuals during this process and all the questions being answered, including your personal information are confidential.

Your study participation is finished at the survey completion. You will have the option to be contacted at a later time for follow-up studies, but only if you indicate so in one of the survey questions.

 

Is there any way being in this research could be bad for me?

There are no physical, privacy, legal, social or economic risks to participating in the research. However, we will be asking about your oral health status, and there may be the potential for psychological risk, since many people can be anxious about visiting a dentist, or thinking about the health of their teeth and mouth.

 

What happens to the information collected for this research?

To the extent allowed by law, we limit the viewing of your personal information to people who have to review it. We cannot promise complete secrecy. The IRB, Temple University, Temple University Health System, Inc. and its affiliates, and other representatives of these organizations may inspect and copy your information.

Survey information will be stored for a period of five years.  In order to conduct follow-up studies, we will ask your permission to be contacted at a later date. If you agree we will save your email address, otherwise your email information will not be saved when the survey is completed.

 

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