Emdogain Information & Consent Form

Application as part of periodontal surgical procedures

What is periodontitis?

Periodontitis is a bacteria-caused inflammatory disease of the periodontium that can lead to tooth movement and, if untreated, can ultimately result in tooth loss. Risk factors for periodontitis are inadequate oral hygiene, smoking and a weakened immune system. Moreover, periodontitis can favor cardiovascular diseases or diabetes.

What is Straumann® Emdogain® and why is it used to treat periodontal diseases?

Straumann® Emdogain® is made of enamel matrix proteins and consists of the body’s own protein amelogenin. It derives from non-erupted porcine tooth buds. It stimulates natural tooth development process, which could be demonstrated by pre-clinical and clinical effectivity and biocompatibility studies. Hence, Straumann® Emdogain® can induce the regeneration of lost soft and hard tissue that has been destroyed by periodontitis. Within the scope of a regenerative therapy, Straumann® Emdogain® significantly contributes to the preservation of periodontally affected teeth.

What is Straumann® PrefGel®?

In a regenerative approach with Straumann® Emdogain®, the tooth root surface is pre-conditioned with Straumann® PrefGel®. Straumann® PrefGel® is pH neutral and binds calcium ions in order to gently remove deposits from the tooth and root surface. The effectivity and biocompatibility of Straumann® PrefGel® are proven by preclinical and clinical studies.

How is Straumann® Emdogain® used in a regenerative approach?

Following local anesthesia, the mucosa of the affected tooth is opened to access the defect and to mechanically remove bacterial deposits and granulation tissue from the tooth root surface. Thereafter, Straumann® PrefGel® is applied in order to thoroughly clean the root surface.

Following application of Straumann® Emdogain®, the wound is sutured and closed. Larger defects can be treated using Straumann® Emdogain® in conjunction with bone grafting material in order to compensate lost bone volume and to stabilize the wound.

The goal of this regenerative therapy is the complete restoration of lost periodontal tissues. By this means, periodontitis-affected teeth can be preserved in a long term and even for centuries as demonstrated by clinical studies. The tissue regeneration is a continuous process lasting for several months. If necessary, the bone formation can be visualized by radiographs at the earliest after one year.

Is a periodontal therapy possible without Straumann® Emdogain®?

A periodontal surgical procedure can be implemented without the use of Straumann® Emdogain®, which in most cases results in the stabilization of the defect (natural repair process); however, it will not achieve a functional regeneration of the lost periodontal structures.

Application as part of oral surgical procedures to support soft tissue wound healing

How is Straumann® Emdogain® used in oral surgical procedures?

Straumann® Emdogain® is used to improve early soft tissue wound healing after oral surgical procedures. Depending on the kind of therapy planned, the mucosa is opened under local anesthesia to place an implant, to augment local bone or to harvest soft tissue. Before final wound closure, Straumann® Emdogain® is applied on the whole wound area and the wound margins.

In surgeries of the gingiva that may not require suturing, Straumann® Emdogain® is applied on the wound margins in the final step of the procedure. Pre-clinical and clinical studies have demonstrated that Straumann® Emdogain® improves closure and healing of wounds after oral surgical interventions by stimulating various cell types related to wound healing. By this means, Straumann® Emdogain® reduces pain and swelling and improves the aesthetic outcome.

How do I behave after a therapy with Straumann® Emdogain®?

To support a fast wound healing, mechanical brushing of the treated area should be avoided for at least 14 days. Instead, the treated surgical area is flushed twice daily with an antiseptic mouth-wash.

A supportive antibiotics therapy is seldom required. A strict and regular recall after a periodontal therapy is very important. Your dentist will advise appropriate oral hygiene measures.

Are there risks or side effects when using Straumann® Emdogain®?

Following periodontal or oral surgical procedures, swelling and pain may appear locally. Inflammation of the wound area is rarely observed. No side effects like immunological or allergic cross reactions could be observed after the application of StraumannEmdogain® until now. However, allergic reactions or irritations cannot be entirely excluded.

In the case of known allergies against any substances, a longer observation period of the patient is indicated following surgery. In addition, the treatment with Straumann® PrefGel® can result in a temporary hypersensitivity of the tooth.

Straumann® Emdogain® and Straumann® PrefGel® are processed in compliance with the highest quality and safety criteria under cleanroom conditions and meet the requirements of national and international standards. Thus, any disease transmission is practically excluded. Scientific experiments also could not demonstrate transmission of diseases.

Takeover of the treatment costs

Costs takeover or participation by private health or complementary insurances and/ or aid agencies cannot be guaranteed. You should submit the treatment plan to your private health insurance and/or aid agency before treatment start in order to clarify costs takeover.