Do you have gum disease? Are you interested in a new clinical study to help gum disease?

Evaluation of a Unified Surgical Instrument System for Minimally Invasive Periodontal Surgery

What is the purpose of the study?

The purpose of this study is to evaluate a surgical instrument system for performing minimally invasive surgery. Minimally invasive surgery is a surgical procedure that uses much smaller incisions than those usually used to treat the bone damage caused by periodontal disease. The surgical instrument system being evaluated uses a videoscope (which is a very small camera) that allows the surgeon to see and treat the bone damage caused by periodontal disease. It also uses instruments designed to be used with the small incisions of minimally invasive surgery.

Who is eligible for this study?

1. You must be between the age of 25 and 75
2. You must be generally healthy with no systemic conditions like diabetes, AIDS or undergoingcancer treatment
3. You must not be a smoker
4. You must not be pregnant or breastfeeding
5. You cannot have teeth which have poor bone support around them
6. You must have at least one tooth with at least 5 mm space between the tooth and gum (pocketdepth), the gum attachment must have receded at least 2 mm, and x-ray evidenceof bone damage.

What will I need to do if I participate in the study?

Before your surgicaltreatment, measurements of your gums will be performed and photographs will betaken of the area that will undergo surgery. Minimally invasive periodontal surgery will then be performed in the area where you have bone damage resultingfrom periodontal disease. This procedure will consist of making very smallincisions at the site of bone damage. Scar tissue (granulation tissue) and infection will be removed from the site of bone damage, and an FDA approved material to stimulate bone growth (Emdogain®) will be placed along with a freeze dried bone graft, and the surgical area will be sutured closed. After the completion of the surgical treatment, you will be reminded to return after1 week, 2 weeks, 4 weeks, 3 months, 6 months, and 9 months for a 30-60 minute follow-up visit. At each of these follow up visits you will have photographs taken of the surgical area, you will be asked to fill out a short questionnaire on your experiences with the surgical area, and you will have varying amounts of cleaning performed on your teeth. At your 9 month visit, measurements will be taken in the surgical area, photographs will be taken, and you will be asked to fill out a questionnaire concerning your experiences and views about the procedures performed for you.

Are there benefits to taking part in the study?

The study is expected to produce information that will be beneficial to other individuals who require treatment for periodontal disease.

Are there any costs to participating in the study?

There is no additional cost to participate in the study. You will be responsible for paying the standard fee for the treatment to be performed upfront. The total cost for minimally invasive periodontal surgery and follow up visits (including periodontal maintenance cleanings at the 3 and6 month visits) is approximately $600. This is the routine cost for periodontal treatment of this type at Baylor College of Dentistry. You will receive a reimbursement of 60% of the total cost of treatment upon the completion of the study. This will be paid in the following manner: 10% of the total reimbursement will be paid at each of the first five follow-up visits; the remaining 50% of total reimbursement will be paid upon the conclusion of the 9 month follow-up. The total of these reimbursements will equal a 60% reimbursement of the total fee for the treatment.

Whom shall I call if I am interested in participating in this study?

Please contact:

Dr. Celeste Abraham

Department of Periodontics

Baylor College of Dentistry

Texas A&M Health Science Center

3302 Gaston Avenue, Dallas,Texas, 75246

Tel: 214-828-8263
E-mail: cabraham@bcd.tamhsc.edu