My signature on the last page of this consent means three things:
I understand all of the statements in these pages
I agree to be a subject in the study
I have received a copy of these pages
About the Study The following people (investigators) are doing this study at the Hennepin County Medical Center:
Dr. Bryan Michalowicz, University of Minnesota, School of Dentistry
Dr. Anthony DiAngelis, Hennepin County Medical Center, Dental Clinic
Dr. Virginia Lupo, Hennepin County Medical Center, Obstetrics Clinic
These investigators are trying to learn if treating periodontal (gum) disease during pregnancy will decrease the likelihood of premature birth or of having a low birth weight baby. They also plan to study whether the treatment will control gum disease and decrease the bacteria or germs in my mouth that cause gum disease. No drugs or other medical devices will be used in this study. The study is being done at the Hennepin County Medical Center, the University of Mississippi, the University of Kentucky and Columbia University/Harlem hospital. Overall, more than 800 women will participate in this study and approximately 204 women will participate in the study at the Hennepin County Medical Center.
My Being in the Study
I am being asked to be a subject in this study for the following reasons:
I am pregnant and I have gum disease.
I am 16 years of age or older.
I have no medical condition that would require me to take antibiotics before dental treatment.
I do not have to be in this study. If I do not participate there will be no penalty, and I won’t lose any benefits to which I am entitled. If I enter the study, I will be enrolled during my second trimester of pregnancy and I will remain in the study until my baby is born. The study will take about six months to complete. I may drop out of the study at any time. If the investigators learn something that might affect my willingness to stay in the study, they will inform me. If I withdraw from the study, there will be no penalty. If they remove me from the study, there will be no penalty. However, the study will not provide or pay for any additional dental or periodontal care that I might need after I leave the study.
Things that Happen Before the Study Begins If I agree to volunteer for the study, I will have an exam of my teeth and gums to see if I qualify for the study. To be in the study, I need to have at least 20 teeth and have enough gum disease to qualify for the study. As part of a routine obstetrical visit, an ultrasound of my baby will be done to learn the gestational age of my baby. I will be excluded from the study if I: 1) am under the age of 16; 2) am unable to give informed consent; 3) am unable to cooperate with the study procedures; 4) am placed at known medical risk as a result of participation; 5) am going to have more than one baby as diagnosed by ultrasound; or 6) require antibiotics for gum treatment because of a heart murmur or joint replacement.
Things That Happen During the Study
One half of the women in the study will have their gum disease treated before their baby is born and the other half will have their gum disease treated after their baby is born. All women in the study will have their gums checked every month during their regularly scheduled prenatal appointments. They will also have their gums measured and a plaque sample taken from their teeth every two months until their baby is born. If I choose to be in the study, I will be scheduled to see a dentist and a dental hygienist in the dental clinic during my second trimester. I will be asked about my medical history and pregnancy. My teeth will be checked for infections and abscesses, cavities, plaque and tartar. The hygienist will measure my gums around my teeth with a dental probe. This will be done to measure the space between my gums and teeth and to see if my gums bleed when they are measured. The hygienist will remove a small sample of plaque from around my teeth. If I qualify for the study, dental x-rays will be taken as needed to see if I have cavities or other problems and a lead apron will be used to protect my baby and me. Dental x-rays are very helpful to find things that may cause more serious problems later. If I qualify for the study, any cavities or other dental problems will be treated. Whenever it is possible, my appointments will be scheduled on the same day as my routine obstetrical visits in the prenatal clinic. Depending on how much dental care I need, the study will take between 8 – 13 dental appointments and it will last 6 months or until my baby is born. Also, I will have approximately 2 teaspoons of blood drawn at the time of my first appointment and again at 25-28 weeks of my pregnancy. This will be done to help evaluate my body’s response to gum infection.
I will have information recorded from my medical record about drug / alcohol use, addiction, and tobacco use. Information about the birth of my baby and my baby’s size and health will also be recorded. Any problems that I may have during my pregnancy will also be recorded. All information that is recorded will be kept strictly confidential. My name will not be recorded on any information that is collected from my records and access to data collected in the study will only be available to study personnel.
Following the study, I will be referred to my dentist if additional dental work is needed, but the study will not pay for any of this additional dental work.
After I am first examined, I will be assigned to one of two study groups. The assignment is totally by chance and the study workers have no way of knowing which group I will be placed in. They will decide this in a way similar to flipping a coin and I will have a 50/50 chance of receiving either of the 2 treatments. I may not choose my group. Starting in the second trimester, one group of patients will have their gum disease treated by a thorough cleaning of their teeth in one or two appointments. They will also receive personal instructions on maintaining oral health. If I am in this group, every month I will also have my teeth polished and receive instructions on care of my teeth and gums until my baby is born. Every other month, I will have a dental exam to check on my gum disease and a small sample of plaque will be collected from my teeth.
Starting in the second trimester, the other group of patients will have a dental exam and a plaque sample taken from their teeth. If I am in this group, I will not receive any treatment for my gum disease until after my baby is born. My gums will be checked during the study and if my gum disease begins to worsen in some areas of my mouth, those areas will be treated. If the gum disease gets worse in several areas of my mouth, I will be removed from the study and my whole mouth will be treated. During the time that I do not have treatment, the chance of my gum disease getting worse is less than 1 in 20. After my baby is born, I will have treatment for my gum disease by having thorough cleaning of my teeth and I will also receive instructions on how to maintain my oral health. I will also be referred to a dentist if additional dental or gum treatment is needed. The study will not provide or pay for any additional dental or gum treatment that I may need.
Withdrawal from the Study
I may withdraw from this study at any time for any reason. There will be no penalty for withdrawing.
I may be withdrawn from the study for the following reasons:
I miss three scheduled appointments.
My obstetrician determines it would be unsafe for me to continue.
My gum disease gets worse and I need more care.
I receive dental care from a dentist or dental hygienist, other than the one involved in the research, without first asking the study coordinator.
If I withdraw from the study or if I am withdrawn from the study by the investigators, I understand that I will not have any needed dental work provided or paid for by the study.
What will happen to the results of the study? Confidentiality
I will have information recorded from my medical record about my health, any addiction that I may have, and about my use of drugs, alcohol, and tobacco. I will also have information recorded about my baby’s health and size. All information that is recorded will be kept strictly confidential. No one except the people working on this study will know that I am in the study. The people who will see my records include the doctors and workers at the clinic or hospital who are doing the study. Also, members of the Institutional review Board, Data and Safety Monitoring Board or other officials as required by state or federal law may see my records. This will only be for reviewing the study material. A code number will identify me, and no one will release personal information about me without my written permission. I will not be personally identified in any published reports of this study and my confidentiality will be strictly preserved.
Risks and Discomforts Pregnant women can receive routine dental exams without harm to themselves or their baby. However, routine dental exams and treatment can cause bacteria or germs that are normally in my mouth to get into my bloodstream. This also occurs whenever I brush my teeth. In order to reduce the risks of preterm delivery, maternal infection, premature rupture of membranes, spontaneous miscarriage or other unknown adverse events, all gum treatment and dental care for this study will be done after the first trimester when the formation of my baby is complete and after the time when most spontaneous miscarriages occur.
It is also possible that treatment of my gum disease will reduce my chances of having a premature baby.
Gum or periodontal disease gets worse very slowly over many years in most people who have no other health problems. If a person has gum disease, it generally does not get worse over a nine-month period to the point where teeth are lost. Pregnancy may cause my gums to become swollen and sore but the bone that holds the teeth is generally not harmed by pregnancy. I will have the health of my gums watched during the study. If there is evidence that my gums are getting worse, I will be offered treatment for those areas that are getting worse. If several areas appear to be getting worse, I may be withdrawn from the study so that I can receive the gum treatment that I need.
Some people find that it is painful to have their gums and teeth examined and cleaned. To make me more comfortable, I may have injections of a local anesthetic (like Novocaine) for the gum treatment or for any dental care. A small amount of local anesthesia is safe during pregnancy. If I am so uncomfortable that I do not want to continue or if I choose not to have local anesthesia as recommended by the dentist, I may withdraw from the study with no penalty. However, I cannot have any needed dental care done free of charge if I withdraw from the study. If I have discomfort that bothers me, I can call the Principal Investigator, Dr. Anthony DiAngelis, at the Hennepin County Medical Center (612) 347-2370. After hours, an on-call dentist can be contacted at the same number. They will report adverse effects caused by the study to the Institutional review Board and the Data and Safety Monitoring Board.
During the third trimester, reclining in a dental chair may be uncomfortable. The dentist will try to make me comfortable by adjusting the dental chair.
There will be no cost to me for participating in this study. I will not receive any reduced prenatal fees or any credits toward care by volunteering for this study. Participation in this study does not change my payment obligation for my prenatal obstetrical care or delivery charges, if I have any. The dentist will try to schedule my appointments on the same day as my prenatal visit, so that I will not have the expense of extra trips to the clinic.
If I am hurt because of participation in this study, the dentists will arrange for me to be treated if I need immediate attention. My health insurance company or I personally may have to pay for this treatment. Neither the investigators nor the institution will provide reimbursement for medical or other costs related to illness or injury caused by participating in the research study.
Inconveniences As a condition of being in the study, I will be asked not to have my teeth cleaned or to have any other gum treatment during my pregnancy. This will be provided for me in the study. If I have my teeth cleaned or have gum treatment outside of the research clinic, I will be asked to withdraw from the study. If I have any questions or concerns abut the care that I am receiving, an outside independent dentist is available for consultation. I will have a dental examination every month during my pregnancy.
By participating in this study, I will learn if I have gum disease and I will receive treatment for gum disease without cost to me. I will receive this treatment either during my pregnancy or after my baby is born. Finding and treating gum disease at an early age helps prevent tooth loss, as I get older.
If I have any cavities, I will have them treated without cost to me. If a tooth needs to be pulled or needs a root canal to save it, that will also be done without cost to me. If I lose a tooth during the study, and this causes a space in the front of my mouth or changes my bite so that I cannot chew, I will have a temporary partial denture made. I will not have any permanent bridgework, caps, or cosmetic dentistry as part of the study. I will also receive valuable oral health information that will be important to my new baby and me.
Participating in this study may or may not decrease my risk of having a premature baby. Knowledge gained in this study could be beneficial to better understand the relationship of gum disease and premature birth.
Due to my willingness to participate I will not be charged for any dental treatment in the study dental clinic. In addition, I will receive a gift certificate from Target worth $20.00 each time I come in for a study appointment. If I keep all of the study appointment, I will receive a total of at least $160.00 in Target Gift Certificates.
If I have a question at any time about this study, I may call Dr. Anthony DiAngelis at (612) 347-2370; he will do his best to answer my questions. If I wish to contact someone who is not associated with the study, I can call Hennepin County Medical Center Office of Human Subjects Research at 612-347-8528. Effects of Periodontal Treatment on Preterm Birth
I have carefully reviewed the contents of this form. I have had the opportunity to ask questions about this study and my participation in it. Before giving my consent by signing this form, I have been informed of the reason, procedures and duration of this study. I have been informed about possible inconveniences, hazards or adverse effects that may result from my participation. By signing this form, I have not waived any of the legal rights that I would otherwise have.
I understand the importance and potential value to me by taking part in this investigation. I understand that there may be risks, both known and unknown. I understand there are unforeseeable risks to my baby and myself. The known risks have been explained to me. I accept these risks and desire to participate. I understand I am participating of my own free will and that I may stop whenever I choose with no penalty or loss of benefits. However, the study will not provide or pay for any needed dental work after I withdraw from the study.
I acknowledge my responsibility to keep my appointments and to report immediately any changes in my health. I understand I may be withdrawn from the study if I fail to keep my appointments. If I am withdrawn from the study, the study will not provide or pay for any needed dental work after that time.
I understand I may see my own dentist for care during the study only after discussing it with the study coordinator. I will be responsible for the cost of these visits. This dental care cannot include any periodontal treatment until after the baby is born. I understand that I will be removed from the study if I receive a dental cleaning or gum treatment from any one other than the research staff.
I understand that the dental treatment I receive is for improvement of my oral health. I will receive no cosmetic dental work.
I understand the study doctor will inform me if my gum disease begins to progress rapidly and that if it does, I will receive the appropriate therapy.
I authorize release of information from this study to those agencies designated by the Principal Investigator.
I, _______________________________________________ have read and do understand all the preceding information describing this study. I have had all my questions answered to my satisfaction. I voluntarily consent to participate in this study. Patient signature:
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: