[Repercussions at the level of required health insurance of the introduction of three distinct professional titles in dentistry]. / Les répercussions au niveau de l'Assurance Obligatoire en soins de santé de l'introduction de trois titres professionnels particuliers en Médecine Dentaire.

From July 2007 on, Belgian dental graduates must complete one year of vocational training in general dentistry or a specialization in the field of either orthodontics or parodontology in order to obtain a licence for the Belgian Social Security System. This introduction of special professional titles required massive legislation in concert with State Health Insurance (RIZIV/INAMI), the Departments of Education of both Communities, manpower planning, comparable arrangements for physicians, and European Directives. Overall the process of subsequent changes in legislation and implementation took up to 15 years. The author includes some critical remarks and indicates what still needed to be done at the end of 2005 to conclude this far-reaching change in the organisation of dentistry in Belgium.

Periodontology as a recognized dental speciality in Europe.

The impetus of the Bologna Process under the auspices of European Union governments has raised enormous expectations. It is the major educational change in Europe within the last 50 years and all the focus from university institutions, learned societies and thematic networks has shifted to this process, with the aim of developing consensus schemes in order to arrive at the expected European Convergence in Higher Education (to be completed by 2010). Dentistry as one of the health professions with clear Educational Standards, as defined by the European Dental Directives, is also reviewing its educational processes within this Bachelor-Master-Doctorate scheme and evaluating how the current and future dental specialities should be accommodated within this framework. Among these specialities, Periodontology is currently considered a formal dental speciality in 11 countries belonging to the EU however it lacks this legal status in the rest of the 14 EU countries. The purpose of this position paper is to provide evidence for the need for a recognized specialty in Periodontology at European level focusing on both the educational and professional perspective, with the hope of providing discussions that may contribute to facilitate its legal establishment as a new dental speciality in Europe.

Guidelines for periodontal therapy. The American Academy of Periodontology.

The American Academy of Periodontology offers the following Guidelines for Periodontal Therapy. These guidelines are intended to fulfill the Academy's obligation to the public and to the dental profession to set forth the clinical objectives and scope of periodontal therapy. They also are designed to give guidance to state legislatures and agencies that regulate the practice of periodontology and should be considered in their entirety.

Dental insurance and the periodontal patient.

Approximately one-half of the United States population is covered by a dental benefit plan. One-fifth of that group is covered under various types of managed care contracts, and this number is said to be increasing by 15% to 20% per year. However, dentists report that these plans have not had a major impact upon their practices. Only 6% of patients were covered by them, and only 2% of gross receipts were derived from them. Periodontists surveyed were divided in their opinions about how managed care has affected their practices. This paper discusses these changes, particularly with regard to income, referral patterns, treatment decisions, and ethical and legal liability.

Legal considerations for periodontists in dealing with managed care organizations.

For well over a decade, increasing numbers of medical patients have transferred from traditional indemnity insurance to managed care organizations (MCOs). Increasingly, MCOs are enrolling dental patients as well. Consequently, it is important for periodontists to understand issues in negotiating with MCOs. This article attempts to advise periodontists regarding what they can and cannot do collectively about managed care and what considerations they should take into account in individually negotiating and dealing with managed care plans.

An overview of Food and Drug Administration regulation of drugs, biologics, and devices to be used for management of periodontal diseases.

The Food and Drug Administration (FDA) has been actively involved in assuring the safety and effectiveness of medical products since 1906. The FDA was granted increased authority to regulate drugs in 1938 and devices in 1976. The regulatory requirements for marketing in the United States vary according to the type of product and the degree of risk associated with it. One route to the market is through the premarket notification [510(kappa)] process in which devices are evaluated according to their substantial equivalence to devices marketed prior to May 28, 1976. Many devices specifically intended to treat periodontal conditions have progressed through the 510(kappa) process based on their substantial equivalence to predicate devices. In some cases manufacturers have needed to provide clinical data in the form of Investigational Device Exemptions (IDE) to support an equivalence determination. Certain devices with indications for use in periodontal evaluation or therapy, specifically, those determined by FDA to be not substantially equivalent to legally marketed devices, require Premarket Approval Applications (PMA). For new drug products, clinical trials are carried out under an approved Investigational New Drug Application (IND). Application for approval for marketing is requested through a New Drug Application. Data from clinical trials conducted outside the United States may be considered by the FDA in support of the safety and effectiveness of the product. The FDA is continually developing and updating guidance documents and guidelines to assist manufacturers in gaining clearance/approval to market new products.

International regulatory aspects of clinical periodontal research.

The Food and Drug Administration (FDA) was the pioneer regulatory agency to set standards for clinical studies aimed at approval of new drugs. For years the FDA's rules represented the most thorough, stringent, and consistent policy. Now most other developed countries have comparable requirements for the conduct of clinical trials. The European Community (EC). Canadian, and Japanese regulations are most important for United States (US) scientists attempting to globalize their research. Regulations in Eastern Europe, some Asian countries, and Latin America are of growing importance. The Pacific-Rim appears to be the fastest growing pharmaceutical market in the next decade. Currently, the EC and Japan's Good Clinical Practice (GCP) regulations are more detailed than those of the US. Moreover, the World Health Organization recently published GCP recommendations similar to the EC requirements. Well-designed and well-controlled studies done in the EC, US, and other developed countries are generally accepted throughout the world. Japan and some other countries require studies in local patients. American scientists cannot expect to conduct studies in other countries as principal investigators, but many are associated with national clinicians. Mutual recognition of marketing approvals is the ultimate goal for the globalization of drug research. While it is the objective of the Scheme for the Mutual Recognition of Evaluation Reports on Pharmaceutical Products and the EC Decentralized Procedure, it is not apparent when the FDA will totally accept another regulatory body's approval decision. The International Conference on Harmonization involves the EC, Japan, and the US. This most important series of meetings will finally align the major countries more closely in regulating clinical studies and the production of safe, effective, and quality products, especially in these times of worldwide economic considerations and health care reform. It is imperative that US dental scientists become more familiar with pertinent regulations in leading foreign countries.

Regulatory issues unique to clinical trials on periodontal diagnostic methods and devices.

A wide variety of in vitro diagnostic products have been proposed for use in patients with periodontal disease. The Food and Drug Administration (FDA) review focuses on three important issues. First, the product must exhibit acceptable analytical performance (accuracy, precision, analytical sensitivity, and analytical specificity). Second, the effectiveness of the device must be clearly defined. The studies required to establish this will depend largely on the proposed intended use of the product. At a minimum, clinical or diagnostic sensitivity and specificity should be established. Finally, the product must meet the labeling requirements for in vitro devices. These requirements outlined in CFR 809.10(b) are comprehensive and cover 15 key elements including information about the principles of the analytical method; handling of instruments, reagents, and patient samples; test limitations; and test performance. Applicants developing products for any in vitro diagnostic device are encouraged to review the labeling regulations along with other divisional and office guidance material to help in defining the submission requirements. The FDA is willing to meet and work with companies prior to and during preclinical and clinical trials to assist in the development of appropriate study protocols.

Periodontics in general practice: professional plaque control.

Traditionally the primary emphasis of preventive periodontics was daily patient performed plaque control. Recent studies indicate that frequent professional subgingival toothcleaning is a mandatory treatment for prevention of recurrent periodontitis. Pathogenic subgingival bacterial complexes are disrupted by frequent cleaning and require time to reestablish. Disease progression is prevented if the recall interval does not exceed the time required for reestablishment of a pathogenic plaque. Legally, patients have acquired the duty to comply with the prescribed recall interval. Both the patient and the practitioner will benefit from a preventive program that includes frequent professional subgingival toothcleaning.

[Dentist periodontist]. / De tandarts-parodontoloog.

In this article criteria and procedures are discussed that are being used to qualify dentist-periodontists (Tandarts-Parodontologen). Also a description is given of the tasks of such a periodontist: consultation, treatment and education. Furthermore figures are presented with respect to experiences of the first group of dentists that have recently been qualified as dentist-periodontist.