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1. Who performs the wisdom tooth extractions?
SCIREX Research Centers works exclusively with board certified
oral surgeons for all of our wisdom tooth extraction studies. To
learn more about our oral surgeons' training and years of clinical
trial experience, click here.
2. Do my wisdom teeth have to be causing me pain or discomfort in
order to qualify for a clinical study?
No. It is not necessary that your wisdom teeth be causing you
pain or discomfort to participate in one of SCIREX's clinical
studies. However, for most studies, it is required that at least one
of your bottom wisdom teeth be partially or completely under the
gums.
3. Can all four of my wisdom teeth be extracted at the same time
if I participate in a study?
SCIREX oral surgeons will typically remove up to two wisdom teeth
at one time (one bottom and one top on the same side). For some
studies three to four wisdom teeth may be removed, but these studies
are less common. You may, however, call us back and re-screen for
another dental study, 30 days after you complete the first study,
provided one is available, and have your other two wisdom teeth
removed if you qualify.
4. What happens during the actual surgery and how long does it
take?
Depending on how the roots of the wisdom teeth are located in
relation to your jaw bone and the surrounding nerves, the length of
surgery may vary. You will have the opportunity to consult with the
oral surgeon who will discuss specific time ranges with you at your
screening visit.
Local Anesthesia
First, the oral surgeon will numb the area where the tooth
(teeth) is to be removed with a local anesthetic. This is for pain
control and will not make you sleepy. It will be injected into the
gums to numb the area and surrounding tissues.
Deep Sedation
Sometimes, if more than one wisdom tooth is extracted at the same
time (and if the study protocol allows), a deep sedation may be used
and is injected into a vein. You, the study participant, are
responsible for the cost. Deep sedation helps patients feel
comfortable throughout the procedure. It is important to note,
however, that most protocols do not allow this.
Wisdom Tooth Extraction
To remove the wisdom tooth, the oral surgeon will open up the gum
tissue over the tooth and take out any bone that is covering the
tooth. He will then separate the tissue connecting the tooth to the
bone and then remove the tooth. Sometimes the oral surgeon will cut
the tooth into smaller pieces to make it easier to remove.
After the tooth is removed, several stitches will be placed to
close the area where the tooth was. Some stitches dissolve over time
and some have to be removed after a few days. The oral surgeon will
tell you whether your stitches need to be removed. A folded cotton
gauze pad is placed over the wound to help stop the bleeding.
5. Will I be sedated?
Most study protocols do not allow this. Please see above
regarding Deep Sedation.
6. How long is the recovery time?
In most cases, recovery time is only a few days. The oral surgeon
will give you a complete list of instructions on steps you can take
to help speed up the recovery time. These will include changing the
gauze pad frequently, using an ice pack and eating soft foods.
7. When should I call the study investigator or research staff?
You should call the number listed on your post-operative
instructions in the event that you experience any of the following
after you leave the clinic:
- Fever of 101°F (38.3°C) or higher
- Still bleeding 24 hours after surgery
- Any increased pain that is not relieved by the pain
medication prescribed
- Any unusual side effects that you may be experiencing from
the investigational pain medication you may have received
8. Will I have to miss work/school?
You may have to miss at least 1–2 days of work or school
depending on the length of the study and how fast you recover.
Following the instructions that the oral surgeon gives you after
your surgery will help speed up your recovery time. If you are
traveling from outside the city where the study is being conducted,
you should make plans to stay in town for one week.
9. How long will I be in the study, when do the study visits
occur, and how long does each visit take?
The length of your participation will depend on the study.
Typically your participation in a study will last approximately 2–3
weeks and will require 3 study visits. Most study visits occur only
on weekdays and others may occur on the weekend depending on the
clinic schedule.
- A screening visit to determine if you are eligible. These
visits typically last 2–4 hours.
- The surgery visit, during which you will have the surgery to
remove your wisdom tooth (teeth) and be randomized to the
investigational pain medication, placebo or active comparator.
This visit will require that you remain in the clinic anywhere
from 6 hours after dosing to 3 nights/4 days in the clinic. The
length of the study will be clearly documented in the informed
consent form.
- A post-surgery follow-up visit typically occurs 5–9 days
after surgery and takes approximately 1 hour. At this visit, the
oral surgeon will look to see how well your wound is healing and
make sure you are not experiencing any complications from the
surgery or from the investigational medication. A few studies do
require a longer time commitment (up to 2 months) and should you
pre-qualify for one of these studies, SCIREX screening staff
will inform you and ask if you wish to be considered for the
longer study or would prefer to be considered only for the
shorter studies.
10. How much will I be compensated for my time and effort?
Compensation for your time and effort varies by study depending
on the number of days/nights involved and the types of procedures
done at each study visit. Compensation is based on actual number of
visits completed and is approved by the Institutional Review Board.
The specifics regarding monetary compensation is included in the
informed consent document that you will be asked to sign prior to
any study procedures being conducted.
11. Will I incur any expenses as a result of my participation?
All of the study related procedures, medical history and physical
exam, the surgery by our board certified oral surgeons and the
investigational pain medication are provided at no cost to you. You
will be responsible for any prescription pain medication you need
once you go home. Typically, you are asked to fill the prescription
prior to coming in for surgery so that it is available to you when
you leave the clinic. The cost of this prescription is about $50. In
addition, if the study protocol allows, you may have nitrous oxide
or deep sedation, however, you will be responsible for the cost.
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