Day 8: Clinical Study 1

Today's pic:

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I was asked to participate in a clinical study that UNC Dental School was conducting together with surgeries such as mine.  I agreed.

Title of Study: Influences on Stability Following Orthognathic Surgery - Skeletal Adaption/Recovery

What is the purpose of this study?

The purpose of this research study is to learn about:

- What happens to your facial bones and jaw joints after jaw surgery.

- How you feel and what you experience during recovery.

- How surgery affects the way you feel about yourself and the way you look.

- How the shape of your jaw and where fixation is placed during your surgery affects whether you experience a change in facial sensation after surgery.

 

Our goal is to document what happens during the clinical treatment that you are going to have so that doctors will be better prepare3d for treating patients like you in the future.  You are being asked to be in the study because you are a healthy patient having orthognathic surgery for the first time.

Are there any reasons you should not be in this study?

You should not be in this study if:

- You have a congenital syndrome.

- You are having treatment because of a recent injury or previous surgery complications.

- You have had previous facial surgery.

- You have had or will have surgery on your chin only.

- You have a systemic medical condition that has degenerative, immune system, musculoskeletal, or neuropathy sequelae.

- You are unable to follow verbal or written instructions in English.

- You do not want to return for the required visits after surgery.

This study lasts three years and requires 4 visits.

 

You will have a cone-beam computed tomography scan (a CBCT scan) taken.  This scan is specifically designed for imaging only the head, rather than the whole body.  This new imaging technique is not currently standard of care for patients receiving surgery involving the head and neck but it provides more detail than the traditional dental radiographs that have been used to see the jaw and jaw joints.  The radiation exposure from a scan of the head (the face and jaw) is approximately 3 times the amount of a single dental panoramic radiograph.  A CBCT scan will be taken a total of 4 times:

 

- Before surgery

- Four to six weeks after surgery

- At the end of orthodontic treatment, usually one year after surgery

- Two years after the end of orthodontic treatment, usually 3 years after surgery

 

It take about 5 minutes to obtain the scan at each appointment.  The cost of each scan will be paid by the research project.

 

You will be asked to complete questionnaires at each visit that ask about the way you feel about yourself, your treatment and the results of your treatment.  It will take about 15 minutes to complete these questionnaires.

 

You will also be asked to fill out a diary questionnaire about how you feel physically and emotionally each day for a period of 3 months after surgery.  It will take 1 to 3 minutes for you to complete the diary each day.  You will be given addressed, pre-stamped envelopes so you can mail the diaries to us.  A research associate may call you on 4 different evenings during the 3 month period to ask how you felt that day.  Each telephone call will take about 3 minutes.

What are the possible benefits from being in this study?

Research is designed to benefit society by gaining new knowledge.  You will not benefit personally from being in this research study.

What are the possible risks or discomforts involved with being in this study?

You may feel uncomfortable about answering some of the questions on the questionnaires.  You are free not to answer any of those questions.

 

During approximately 40 months, a maximum of 4 CT scans will be taken of your head.  The radiation that you will be exposed to from all of these 4 CT scans is 27 mrem which is about the same as the amount of radiation that you receive from natural sources in 27 days.  This radiation is in addition to the radiation that you receive from panoramic radiographs and cephalograms that may be taken for diagnosis and clinical assessment purposes during that same period.

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The smoothie recipe below is one of my new favorites.  Obviously, I have a sweet tooth.  The first time we made it with blueberries as called for in the recipe, but today we made it with strawberries.  Just as good!  Tip: if you use frozen fruit you don't need the ice.

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Back with the puzzles!  Stay tuned tomorrow for the punch lines!