Severe periodontal disease affects about 35 percent of people over 55 years. Emdogainｮ aims at a yearly market world-wide of about five million surgical procedures in patients with severe periodontal disease.

The next generation

Emdogainｮ is an enamel matrix protein that recreates all necessary tissues for true functional attachment in patients presenting with moderate to advanced periodontitis.

Emdogainｮ represents a completely new way of thinking about the regain of functional tooth support. Designed to be a simple adjunctive product, Emdogainｮ fits naturally into established periodontal treatments. The Emdogainｮ product is packaged in two vials ? a vehicle solution and freeze-dried enamel matrix proteins (the amelogenin fraction). When mixed, they create a viscous, easy to use, syringable gel that is applied quickly and easily during normal flap surgery.

Emdogainｮ prompts a natural biology-based response in the body.

Emdogainｮ is resorbed naturally during the normal healing process, leaving only a residue of enamel matrix proteins on the debrided root surface. This natural and insoluble surface layer encourages the population of cementum-forming cells from the surrounding tissues. The newly created surface also functions as an interface between the tooth and the surrounding tissues, preventing downgrowth of epithelial tissues. In promoting rapid initial healing, Emdogainｮ causes little or no associated postoperative pain and swelling.

Emdogainｮ creates a surface for cementum production

Experimental studies in a marginal dehiscence model in primates show that Emdogainｮ creates a suitable surface for the colonization of cementum-forming cells. Two weeks after application, 75% of the dentin surface is covered with such cells. After cementum formation the periodontal ligament and alveolar bone are then established.

A product as safe as it is effective

The safety of Emdogainｮ has been completely documented. A thorough toxicology program, including acute and chronic studies, in vitro mutagenicity studies, reproductive toxicology tests, and several additional toxicology studies has been carried out. The potential for sensitization and other immunological reactions in human were also examined. No immunological or allergic reactions were found.

Clinical documentation for Emdogainｮ has been obtained from a series of strictly designed studies involving nearly 300 patients at 15 clinics throughout U.S.A. and Sweden. Patients have been followed for over three years and have shown uniform improvement in Emdogainｮ treated teeth compared to control surgery, by achieving statistical significance for probing pocket reduction, clinical attachment gain, and radiographic bone gain.

DIRECTIONS FOR USE

Each set of two vials is intended for use in one patient only. The Emdogainｮ gel from each set of vials is sufficient for the treatment of at least three teeth.

Preparation of Emdogainｮ gel - Preparation should be initiated approximately 15 minutes before application. Until then the vials should be stored in refrigerator.

1. Remove the center of the cap of the vial with the vehicle solution. Use a sterile syringe (3-5 ml) with sterile cannula (min. 1.2 mm diameter) and slowly draw about 1 ml of vehicle solution through the rubber stopper.

2. Remove the center of the cap of the vial with Emdogainｮ and add the vehicle solution through the rubber stopper. Rotate the vial a few times to distribute the solution.

3. Wait until the Emdogainｮ powder is dissolved by the vehicle solution. Do not heat!

4. Withdraw the gel slowly to reduce air entrapment. Change to a short needle with a blunt end.

5. Use the Emdogainｮ within 2 hours and discard any remaining gel.

　

Clinical Procedure - The Emdogainｮ gel is intended for use in conjunction with conventional periodontal surgery:

1. Anesthetize the area selected for surgery by block and/or infiltration anaesthesia. Avoid injection of local anaesthetic with a vasoconstrictor into the interdental papilla or marginal gingiva.

2. Make intracrevicular incisions. Then, if judged appropriate, make one or two vertical releasing incisions extending out into the alveolar mucosa. Raise full-thickness (mucoperiosteal) flaps on the buccal and palatal/lingual surfaces of the teeth.
Preserve as much of the gingival connective tissue in the flap as possible. Maintain viability of periodontal cells by hydration of the soft tissue with saline.

3. Only remove the granulation tissue adherent to the alveolar bone and any associated osseous defects necessary to provide full access and visibility to the root surfaces. Remove subgingival plaque and calculus. Etch quickly (e.g. 2 min with PrefGel^TM or 15 s with citrate or phosphoric acid). Rinse thoroughly with sterile saline. Avoid contamination of the surgical area with saliva or blood after the final rinse.

4. Immediately apply Emdogainｮ Gel onto the exposed root surfaces, starting at the most apical bone level. Apply Emdogainｮ to fully cover the exposed root surface areas. (Overflow of surplus material during suturing should occur).

5. Complete coverage of the interproximal area and optimal soft tissue adaptation is essential. If deemed appropriate, a periosteal fenestration at the base of the flap may be used to facilitate coronal repositioning of the soft tissue. Suture materials appropriate for extended stable closure should be preferred.

6. The patient should be advised to rinse daily with an antiseptic mouth rinse (e.g. 0.1 - 0.2 % e.g. chlorhexidine solution) until 3 -6 weeks post-surgery. Antibiotics may also be used if deemed appropriate based on the clinician's judgement.

7. The patient should be instructed not to brush in the area where surgery has been performed until 3 weeks postoperatively. Then only gentle brushing on buccal and lingual surfaces using the "roll-stroke" method is recommended. No sulcular or interproximal tooth cleaning must be performed until 6 weeks postoperatively.

8. Sutures may be removed when the flaps and the root/soft tissue interface are stable, usually within 2-3 weeks. Consistent with conventional post-surgical care all patients should be reinstructed in proper oral hygiene measures as needed. Healing of clinical attachment and alveolar bone has been shown to continue for more than a year, and care should be taken not to interfere with this process.

PrefGel^TM