SOFT TISSUE GRAFTING USING ALLODERM REGENERATIVE TISSUE

GRAFTING INFORMATION AND CONSENT FORM 

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1. I have been informed and I understand the purpose and the nature of the Soft Tissue Grafting (Gum Grafting) procedure that will be performed to place a gum graft material onto the deficient root or jaw site. The purpose of placing this graft can be one of several a) to cover my exposed root and reduce the recession present. Recession can lead to esthetic challenges, to root decay & increased root sensitivity to cold, hot, sweets, air. b) to increase the height of my jaw under bridges so that the bridge is much more esthetic and the food trapped under the bridge is less c)to eliminate/reduce the "dark/grey" hue/discoloration of my gums that can be present anywhere but especially around crowns and bridges. d) to allow my periodontist (Dr. Farzin Ghannad, Dr. Hannu Larjava, Dr. Nabil Nadji, Dr. Robert Straga, Dr. Farzan Ghannad) to improve the tissue quality around my crowns or implants. This will lead to better long term results in terms of esthetics, function, sensitivity, etc. e) to allow my periodontist to proceed with bone grafting by improving the quality of tissues over my bone graft f) for other reasons that my periodontist mentioned to me.

2. Alloderm can be used when my own tissue is not adequate (in quantity/quality) in order to perform the necessary procedure or because I want to avoid the additional wound/discomfort in the palate or other areas of my mouth. Alloderm allows me to have this gum graft without having to experience the uncomfortable postoperative healing period that is associated with this type of procedure (when my own tissue is used instead of alloderm 3. Alloderm is processed tissue that comes from donors who are extensively screened and tested for presence of diseases including known viral diseases like Hep B, Hep C, HIV, etc. Samples of the actual donor tissue are tested for and shown to be free of bacterial and fungal pathogens. 4. The processor company LIFECELL CORP, only accepts tissue from organization that meet the standards of the American Association of Tissue Banks (AATB) and the tissue must also pass rigid guidelines set by the U.S. Food and Drug Administration (FDA LIFECELL's proprietary tissue processing adds substantially to the safety profile of the product including substantially reducing the potential for viral contamination.

5. Since it's introduction in 1994, there have been more than 900,000 Alloderm grafts placed with no confirmed incidence of disease transmission.

6. The gum graft that will be placed (Alloderm) is of human origin. Alloderm is an acellular (no cells) dermal matrix derived from donated human skin tissue supplied by tissue banks utilizing the highest standard requirements.

SOFT TISSUE GRAFTING USING ALLODERM REGENERATIVE TISSUE

GRAFTING INFORMATION AND CONSENT FORM 

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7. Alloderm provides a matrix that consists of collagens, elastin, blood vessel channels and proteins that support re-vascularization and cell repopulation and tissue remodeling. After placement, significant revascularization (blood vessel formation) can begin as early as one week. The host cells respond to the local environment and the matrix is remodeled into the patient's own tissue, in a fashion similar to the body's natural cell attrition and replacement process.

8. In approximately 4-8 weeks after placement, the Alloderm has healed to a significant extent providing you with the advantages associated with its use.

9. Although the success rate of Alloderm grafting is extremely high when following the manufacturer's handling protocol, I understand that occasionally there are complications in surgery and infectionof the graft and/or host tissues may occur and they may become compromised.

10. It is understood that although good results are expected, they cannot be and or not implied guaranteed or warrantable. There is also no guarantee against unsatisfactory or failed results.

11. I have fully disclosed any adverse reactions I've had to drugs. I'm fully aware that I am not supposed to receive this graft if I'm allergic to any antibiotics.

12. I understand that I am not to use alcohol or non-prescribed drugs during the treatment period. Dr. Farzin Ghannad, Dr. Hannu Larjava, Dr. Nabil Nadji, Dr. Robert Straga, Dr. Farzan Ghannad has discussed with me that smoking is particularly harmful to the success of this operation and could lead to potential failure. I have been requested to stop smoking.

13. I have been informed and I understand that occasionally there are complications of surgery, drugs and anesthesia including but not limited to: Pain, swelling, discoloration of the face, neck and mouth. Infection of the tissues, that might require further treatment including hospitalization & surgery Delayed union or non-union of the tissue graft material to normal gum tissue Postoperative unfavorable reactions to drugs, such as nausea, vomiting and allergy.

14. I understand that Dr. Farzin Ghannad, Dr. Hannu Larjava, Dr. Nabil Nadji, Dr. Robert Straga, Dr. Farzan Ghannad 15. will give his best professional care toward the accomplishment of the desired results. I understand that I can withdraw from treatment at any time.

16. I give permission to photography and/or video recording of this procedure for treatment planning, documentation of my ongoing care, teaching and research. My anonymity is guaranteed.

17. I authorize and request Dr. Farzin Ghannad, Dr. Hannu Larjava, Dr. Nabil Nadji, Dr. Robert Straga, Dr. Farzan Ghannad to perform this Alloderm tissue grafting surgery on my jaw and such additional procedures as may be found necessary in the judgment of my doctor during the course of this treatment. I understand unforeseen circumstances may necessitate a change in the desired procedure or in the rare cases, prevent completion of the planned procedure.

18. I hereby state that I read, speak, and understand English.