Clinical Use of Emdogain for Regeneration of Periodontal Defects
A treatment option with capabilities to regenerate periodontal tissue.
By Donald S. Clem, DDS; and Nelson T. Yen, DDS, MS
The treatment aim of vertical periodontal defects is the regeneration of a true functional attachment. By definition, periodontal regeneration involves the reconstruction of three different tissue types: cementum, periodontal ligament, and bone.1 Therefore, true periodontal regeneration can only be shown through histological results. This means that the clinician must rely on radiographic bone fill and gains in clinical attachment levels as well as probing depth reduction to evaluate the effectiveness of regenerative therapies.2 Therapeutic interventions should rely on the evidence-based approach.3 For a material or technique to be considered “regenerative,” it must show histologic evidence of periodontal regeneration, stand up to randomized controlled clinical trials, and have a body of literature in peer-reviewed scientific journals that demonstrate clinical as well as statistical significance.
The use of Straumann® Emdogain™ (Straumann, www.straumann.com) offers a treatment option with capabilities to regenerate periodontal tissue as shown in several pre-clinical, human histological case reports and randomly controlled clinical trials.4-8 To date, over 3,000 defects treated with Straumann Emdogain have been evaluated through more than 400 published clinical studies, demonstrating clinical effectiveness.
Successful Treatment of Vertical Defects
Decisions regarding which regenerative material or technique to use normally focus on the size and shape of the defect. A clinical decision tree for the treatment of periodontal intraosseous defects has been published by Froum et al.9 This tree (Figure 1) recommends that Emdogain should be used in periodontal osseous defects to promote the regeneration of the tissues in the periodontium. The addition of other materials is based on defect dimensions and the need to have additional support during the healing period.
Application of Clinical Concepts
In practical application, as general rule in the authors' practice, they primarily use Straumann Emdogain for the treatment of intrabony defects. Depending on the size and morphology of the defect, they will then add a bone graft material, such as demineralized freeze-dried bone allograft (DFDBA), as needed.
For example, it is very important to select defects that lend themselves to flap support when Straumann Emdogain is employed as a monotherapy. More extensive, complex defects frequently require the addition of a bone graft material for flap support.9-13
Clinical Case Reports
Two patients were referred to the authors' practice by their general dentists, both due to demonstrated clinical evidence of attachment loss with increased probing depth. The authors believe it is important that restorative dentists and periodontists work together in a team approach for optimal patient outcomes. Vertical lesions have a much higher risk of continued attachment loss and regenerative interventions should be considered early in their diagnosis. The periapical radiographs presented two different situations. The first patient, a 46-year-old woman, presented with what appeared to be a deep, well-contained defect on the distal aspect of the left mandibular first molar, probing at 10+ mm (Figure 2, Figure 3 and Figure 4). The radiographs of the second patient, a 51-year-old woman, confirmed the presence of a deep vertical defect on the distal aspect of the right mandibular first molar (Figure 5). The lesion of the second patient showed an 8-mm defect along the distal aspect of the first molar extending past the distal-facial line angle (Figure 6). As the authors would not know until they entered the sites what materials might be necessary, patients are often presented with the possibility of the various materials that might be needed in order to ensure the success of treatment.
The goal of both treatments was not only to decrease the clinical probing depth, but to also gain clinical attachment and realize a gain in bone. Ultimately, the authors wanted to minimize the vertical component of the defect as much as possible. In addition, regenerative therapy has the unique advantage of preserving crestal bone height and soft tissue contours for improved esthetics over resective approaches.
In consideration of the goal of periodontal regeneration for this lesion, there are only a limited number of materials and techniques known to result in human histological evidence of regeneration. This means that evidence of new cementum, new alveolar bone, and new periodontal ligament must be demonstrated. Two such materials are demineralized bone allograft and Straumann Emdogain. Depending on the lesion, these materials used either alone or in combination have demonstrated both histological evidence of regeneration and clinical effectiveness through peer-reviewed scientific literature.14-18
From the standpoint of technique, the authors prefer sulcular incisions to allow for conservation of as much tissue as possible. After reflection of full-thickness facial and lingual flaps, extensive root preparation was done. While ultrasonics and hand instruments were used, their effectiveness and ease of access to the lesion are limited and can become compromised when dealing with deep lesions like this. Because of this, the authors often employ the use of high-speed finishing burs and diamonds to facilitate easier and more complete root preparation. The use of a 24% EDTA solution (Straumann® PrefGel®) to the prepared root surface for 2 minutes completed this process. After thorough rinsing of the site with sterile saline, the authors packed the defect with saline-soaked gauze to control bleeding.
At this point in the procedure, the authors make a final decision on which material or combination of materials or techniques will be employed. Because the primary goal is periodontal regeneration with predictable results, Straumann® Emdogain is the authors' treatment of choice and was used in both cases. For the first patient, the authors decided to use Emdogain as a monotherapy due to the depth and morphology of the defect. They were able to get excellent flap support with the existing bony walls and, therefore, did not need any additional materials.However, in the second case, as the lesion wrapped around the facial (Figure 6), a bone graft substitute (DFDBA from LifeNet Health®, now available directly from Straumann) was also packed in the site after the application of Straumann Emdogain for flap support prior to flap closure. The first application was with Emdogain to saturate the root surface to initiate the regenerative process. Evidence suggests that enamel matrix proteins, a constituent of Emdogain, function not only to stimulate cell proliferation, but also function as signaling proteins in selecting cells to differentiate into cementoblasts.19,20 This is an essential step in periodontal regeneration. After this initial application, the authors then packed DFDBA that had been hydrated with sterile saline directly into the defect. Emdogain in combination with bone grafts has been shown to be osteopromotive.21-24 Closure was completed with a non-braided, non-absorbable continuous suture.
For all regenerative cases, the sutures are left in place for 2 weeks to maximize wound stabilization, as seen in Figure 7. During that time there was no periodontal dressing used. The patient was instructed in the use of a chlorhexidine swab twice daily. The authors also place these patients on an antibiotic (usually doxycycline) for the first 10-day postoperative period. Thereafter, the patient is seen at 2-week intervals over the next 8 weeks for plaque control and postoperative follow-up.
The authors gently probe the site at a final postoperative visit at 8 weeks and then place the patient on periodontal maintenance every 3 months. They generally do not take a radiograph of the site until 6 to 9 months post-regenerative treatment. Since the healing of intraosseous defects in regeneration involves disparate tissue types, bone is the last tissue to be formed in a mature enough state to be evaluated radiographically. It is well established that increases in bone volume and density continue for some time (some authors report 3 years) after regenerative therapy.4,25 While the authors generally alternate maintenance visits with the referring dentist for patients who are comparatively low risk, regenerative patients are seen in our office exclusively for the first 6 months after surgery. This is because the regenerative site(s) is managed with a strict treatment and monitoring protocol using modified ultrasonics, focused plaque control instructions and, in more severe cases, long-term anti-inflammatory medications. The authors believe that it is important that the periodontist direct the postoperative management for this critical 6-month period. After this first 6-month period, the patient is usually returned to an alternating schedule with a shared responsibility between the general dentist and periodontist.
The clinical results demonstrate a 7-mm gain in clinical attachment with minimal probing depth (Figure 8). The radiograph demonstrates favorable bone response with increased fill and density, which is an indicator of an excellent regenerative response (Figure 9). This region was now amenable to long-term maintenance care. True periodontal regeneration can only be shown with a notch placed at the apical extent of calculus and histologic evaluation showing new bone, new cementum, and periodontal ligament. Bone fill and attachment level gains are the primary evaluation points for clinicians to assess the effectiveness of therapy.
Similarly, the clinical results demonstrate a 5-mm gain in clinical attachment with minimal probing depth (Figure 10). The radiograph demonstrates favorable bone response with increased fill and density, which is an indicator of an excellent regenerative response (Figure 11). This region is now amenable to long-term maintenance care.
Periodontal regeneration in the treatment of periodontal diseases is preferable to both patients and clinicians, because there is the opportunity to restore lost hard and soft tissues as well as decrease probing depths. With these goals in mind, the authors have found that Straumann® Emdogain, either alone or in combination with a bone grafting material, can provide safe, effective, and predictable results in their practice. Clearly, the decreased probing depths will allow for easier and more effective maintenance care while preserving function and esthetics. In most cases, the authors prefer to avoid presurgical root planing when considering periodontal regenerative options, and move directly into the reconstructive phase after a plaque-control program with the patient. The more soft tissue remaining at or above the cemento-enamel junction, the more soft tissue will be available for covering the wound. It is long been accepted that a significant amount of probing depth reduction with root planing occurs as a result of recession. Therefore, the rationale for moving to a regenerative approach early in the diagnosis is supported by: 1.) The behavior of intraosseous defects that demonstrate little to no bone regeneration after simple root planing; 2.) Root planing frequently results in recession, which can be both an esthetic complication and may make regenerative procedures more difficult due to lack of soft tissue.26-28
It is important that periodontists and referring dentists establish protocols for identifying these patients at high risk who may benefit from advanced regenerative therapies early in their diagnosis. Restorative care will be more predictable, more easily maintained, and the patient will have been reconstructed with a new attachment apparatus that replicates the form and function of their original anatomic structures. That is what the team approach is all about—optimal clinical outcomes in the patient’s best interest. The authors are fortunate to work with a wonderful team of referring dentists and hygienists in this regard and would encourage their periodontal colleagues to actively engage their dental community to function as their resource in achieving these outcomes for the patients they serve.
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About the Authors
Donald S. Clem, DDS
Nelson T. Yen, DDS, MS