Obstetrics and Periodontal Therapy (opt) Study Manual of Operations Version 1 March 3, 2003 Brief Table of Contents



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Compensation:

You will not be paid for participating in this study.


Potential Risks:
Pregnant women can receive routine dental care without harm to themselves or their baby. However, routine dental exams and treatment can cause bacteremia which means germs that are normally in your mouth get into your bloodstream, something which happens whenever you routinely brush your teeth, too. There is no information to say that this will cause harm to your baby or you. Some people find having their gums and teeth examined is uncomfortable. Participating in this study may involve risks to you and your baby which are currently unforeseeable.
Potential Benefits:
You will receive no direct benefit from participating in this study screening exam.
Confidentiality:
The study doctors and study staff will have access to your records, and the Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), the University of Mississippi’s Medical Center’s Institutional Review Board (IRB) and Office of Compliance may review the study records. You will not be personally identified in any published reports of this study.

I, ________________________________ have read and do understand all the preceding information describing this study, and all my questions have been answered to my satisfaction. I voluntarily consent to participate in this study.


I understand that by signing this form I am not waiving any legal rights I may have.
________________________________ _________________________

Signature of the Participant Date


_________________________________ __________________________

Signature of Witness to the Signature Date


I have explained to the volunteer the purpose of participation in this study, and have answered the volunteer's questions. To the best of my knowledge, she understands the purpose, procedures, risks and benefits of this study.
Person obtaining informed consent: ___________________________________
Signature of person obtaining informed consent: ________________________ Date_________________
Signature of Investigator:__________________________ Date_______________
Principal Investigator: William Buchanan, DDS

University of Mississippi

School of Dentistry

Department of Periodontics

2500 North State Street

Jackson, Mississippi 39216-4505

(601) 984-6118
Chairman of the Institutional Review Board: Stanley Chapman, MD

Department of Medicine

Division of Infectious Diseases

2500 North State Street

Jackson, Mississippi 39216-4505

(601) 984-2815

LBW screening informed consentIRB 1202 shorter.doc
III.6.5.2 Consent form for Jackson Enrollment Site


PATIENT INFORMED CONSENT
EFFECTS OF PERIODONTAL THERAPY ON PRETERM BIRTH
Principal Investigator: William Buchanan DDS, Associate Professor

Department of Periodontics

University of Mississippi School of Dentistry

Co-Investigator: James Bofill, MD, Assistant Professor

Maternal-Fetal Medicine

University of Mississippi School of Medicine


Sites: University of Mississippi Medical Center, Jackson Medical Mall

Hennepin County Medical Center, Minneapolis, Minnesota


University of Kentucky, Lexington, KY
Columbia University/ Harlem Hospital, New York, NY
Introduction:
Because you are pregnant and because you also have periodontal disease (gum disease or pyorrhea), you are being invited to participate in a research study that will help determine if treating gum disease will decrease the risk of having a premature baby. Periodontal disease is an infection caused by bacterial plaque (germs) that very slowly and painlessly destroys the bone around your teeth. We want to find out if treating your gum disease will decrease the chance of having a premature baby.
Purpose of the Study:
The purpose of the study is to determine if periodontal treatment will help to prevent women from having premature babies. There are many known risk factors for having a premature baby. These include diabetes, hypertension, smoking, age, genital tract infection, previous low birth weight baby, drug abuse and socioeconomic status. There are also some unknown risk factors. Recently, some scientists have suggested that periodontal disease may be one of the factors that cause pre-term low birth weight babies. The investigators will also study whether the treatment will control gum disease and decrease bacteria or germs that cause gum disease. No drugs or other medical devices will be used in this study. Approximately 206 women will participate in this phase of the study at each site.
Study Procedures: What will happen if you are in the study
If you choose to be in the study, you will be scheduled to see a dentist in the Jackson Medical Mall Dental Research Clinic during your second trimester. Your teeth will be checked for cavities, plaque and tartar. A small amount of blood, about 2 tablespoons, will be drawn. Also, a dental probe with a dull tip will be moved around your teeth to measure the space between your gums and teeth and to see if your gums bleed when they are gently touched. A small sample of the plaque around your teeth will be scraped off. You will also be asked some questions about your medical history and pregnancy.
After your exam, you will be assigned to one of two study groups. The assignment is totally by chance, similar to the flip of a coin. The study workers have no way of knowing which group you will be placed in. You may not choose your group.


If you are in Group One:


Starting in the second trimester, you will have your teeth cleaned and will receive personal instructions about maintaining good oral health. Each month, you will have your teeth polished and oral hygiene instructions will be reviewed. Every other month, a brief dental exam will be done to check on the state of your periodontal disease. A small sample of plaque will be collected at that time. Any cavities or other dental problems will be treated. This will continue each month until your baby is born. Around 24-28 weeks, about 2 tablespoons of blood will be drawn. After your baby is born, a nurse will record information about your health and medical background from your medical record. Following the study, you will be referred to your dentist if additional dental work is needed, but the study will not pay for any of this additional dental work.
If you are in Group Two:

Starting in the second trimester, you will have a dental examination and plaque sample collection each month. Any cavities or other dental problems will be treated. If signs of periodontal disease begin to worsen, you will be removed from the study and you will receive treatment. At around 24-28 weeks, about 2 tablespoons of blood will be drawn. After the baby is born, a nurse will record information about your health and medical background from your medical record.


Then you will receive a complete cleaning and periodontal treatment and will be referred to your dentist if additional dental work is needed.
For Both Groups:

We will record information from your medical records about drug and alcohol use and addiction, as well as tobacco use. We will also record information about your baby's health and weight. All information that we record will be kept strictly confidential. We will not record your name on any information that we collect from your records and access to data collected in the study will only be available to study personnel. You will be asked to sign a separate form that gives your permission for the study doctors to look at and record your delivery information and also your baby's medical records.


Voluntary Participation:
If you choose to be in the study, you can stop at any time for any reason. You will not be treated differently if you decide not to be in the study or stop being in the study after you start.
Withdrawal from the Study:
You may withdraw from the study at any time for any reason. There is no penalty to you for withdrawing. If you do not want to continue or choose not to have local anesthesia, then you may withdraw from the study with no penalty.
You may be asked to withdraw from the study for the following reasons:

  1. you miss three of your scheduled appointments

  2. your obstetrician determines it would be unsafe for you or your baby to continue

  3. our examinations show that your periodontal disease is spreading rapidly and you need more advanced care

  4. you receive dental care from a dentist other than a research dentist without first asking the research doctors.


Duration of the Study:
Your participation in the study will last until after your baby is born.
Your rights:
This consent form gives you information about the study that will be discussed with you. After we talk to you about the study, you will be given this form to take home. If you decide to volunteer after reading and thinking about this information,

you will be asked to sign this consent form. You will be given a copy of this to keep.


It is important for you to know:

  • your participation is strictly voluntary

  • you may decide not to participate in the study or to withdraw from the study at any time without penalty or loss of benefits or treatment to which you are entitled

  • you will be told about any changes to the study and any new information that we learn that may affect your willingness to participate in this study and you may be asked to sign a new consent form.

  • if early results show that there is a relationship between periodontal disease and negative birth outcomes, you will be told and will be offered the appropriate treatment

  • you have the right to ask questions concerning the potential or known hazards of this study at any time. If you have any questions regarding your rights as a volunteer subject or about the study, contact Dr. William Buchanan at the

  • School of Dentistry at (601) 984-6118 or on his cell phone at 601 594-6551


You may discuss your rights as a research subject with Dr. Stanley Chapman, Chairman of Institutional Review Board of UMMC, at (601) 984-2815.
Cost to You:
There is no cost to you for participating. All the dental treatment you receive from the research clinic will be free of charge. Participation in this study does not change your payment obligations for your prenatal obstetrics visits or delivery charges, if you have some. In case of injury or illness resulting from your participation in this study, medical treatment is available to you at the University of Mississippi Medical Center. You will be charged the usual and customary charges for any such treatment you receive.
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