ACADEMY OF LASER DENTISTRY COMMITTEE ON REGULATORY AFFAIRS TABLE OF CONTENTS

Transcription

1 ACADEMY OF LASER DENTISTRY COMMITTEE ON REGULATORY AFFAIRS INFORMATION PACKET FOR STATE BOARDS OF DENTISTRY May 2014 TABLE OF CONTENTS 1. Mission Statement of the Academy Position Statement on the Use of Lasers in Dentistry Dental Laser Certification Programs Curriculum Guidelines and Standards for Dental Laser Education Selected Laser Dentistry References FDA Marketing Clearances by Indications for Use phone Regulatory Affairs Committee Information Packet for State Regulatory Boards 04_28_2014 Page 1

2 1. MISSION STATEMENT OF THE ACADEMY OF LASER DENTISTRY The Academy of Laser Dentistry (ALD) is an international professional membership association of dental practitioners and supporting organizations dedicated to improving the health and well-being of patients through the proper use of laser technology. The Academy actively supports education and research through its certification programs, publications, meetings, and additional activities. The Academy fosters dialogue and seeks to build community among its representatives and others who share this mission. 2. POSITION STATEMENT ON THE USEAGE OF LASERS IN DENTISTRY* The Academy of Laser Dentistry is an independent, professional organization devoted to the advancement of laser dentistry and serves the dental community by objectively providing education in all useful laser wavelengths. Lasers have been in dentistry for more than two decades and this experience has led to questions about appropriate use. These questions present a challenge not only to those considering laser usage in their practices but also to those who regulate the practice of dentistry. Many boards are considering how to deal with a new technology that was not even envisioned when most state dental practice acts were written. The ALD has been a leading organization in this rapidly developing field since its inception. Academy members are the leaders in laser research, treatment, training, education, testing, and manufacturing. Many of our members are involved with organized educational consultants and serve as resources to dental groups, regulatory agencies, state boards, and the U.S. Food and Drug Administration (FDA). The Academy is honored to be considered a source of information, training, and certification for laser users and those with interest in the use of lasers in dentistry. We believe usage parameters should be defined within the law, rules, and guidelines set forth in each state s dental practice act. We therefore make the following recommendations regarding safe and effective laser usage: The ALD supports the use of lasers in dentistry when used by a properly trained and licensed dental professional where the procedure is safe, effective, and consistent with his/her education and experience, and within the scope of his/her licensure. If such procedures are permitted under the existing dental practice act, we believe the provider of dental services (dentist, hygienist, or dental assistant) should be able to choose any device suitable to perform that procedure, laser or otherwise if that device is safe and effective, and if the use of that device is consistent with the provider s education, training, and experience. Lastly, the ALD recommends that practitioners wishing to use a laser complete, at minimum, a Category II Standard Proficiency level certification course as described in the Curriculum Guidelines and Standards for Dental Laser Education. In brief, this includes a minimum of 12 hours of specific educational activity that should incorporate hands-on training on the specific device the practitioner intends to use and a measured outcome learning verification exercise. The ALD would like to help ensure both the preservation of public safety and the freedom of clinical judgment by practitioners. phone Regulatory Affairs Committee Information Packet for State Regulatory Boards 04_28_2014 Page 2

3 * The full position statement is available on the ALD Web site, 3. DENTAL LASER CERTIFICATION PROGRAM One of the major objectives of the Academy of Laser Dentistry is to develop educational and clinical standards in laser dentistry in order to help promote safe and efficacious laser use on patients. Successful completion of the certification program is a way to formally demonstrate advanced knowledge and clinical proficiency in laser dentistry. The program is a structured educational mechanism for dental practitioners wishing to achieve high standards of dental laser care. While four levels of education are outlined, the primary recommendations are the Standard and Advanced Proficiency certification. STANDARD PROFICIENCY 1. The candidate must show successful completion of a recognized introductory course. The required hours needed to satisfy this prerequisite are equal to or greater that 2.5 credit hours. 2. The candidate must own or have access to a dental laser. Standard Proficiency is the basic level of education in dental laser usage; it includes specific laser proficiency and laboratory knowledge. Candidates for standard proficiency must demonstrate basic understanding of all wavelengths via an online, 75-question measured outcome learning verification exercise and give a clinical simulation proficiency demonstration with at least one laser wavelength. The standard proficiency level was developed to define the standard of care for the dental professional. This must be an ALD-approved course of at least 12 hours. (This does not include the introductory hours). The standard level of proficiency also forms the base credential for progressing to the Advanced Proficiency level. ADVANCED PROFICIENCY Advanced Proficiency represents advanced knowledge and clinical experience with a dental laser. Candidates for advanced level recognition must demonstrate knowledge of all laser wavelengths via an online 175-question examination and demonstrate advanced clinical proficiency using the dental laser of their choosing. Dental practitioners who provide laser treatment must also prepare five (5) clinical case studies and be prepared to present a minimum of two of them before the Academy examiners. Laser safety officers do not participate in the case study presentation section of the examination. This level of education exceeds the suggested standard of care for the dental professional. phone Regulatory Affairs Committee Information Packet for State Regulatory Boards 04_28_2014 Page 3

4 4. CURRICULUM GUIDELINES AND STANDARDS FOR DENTAL LASER EDUCATION The Curriculum Guidelines and Standards for Dental Laser Education is a document that defines the standard of education for practitioners who use lasers. Initially drafted during a workshop organized at the University of California, San Francisco (UCSF) School of Dentistry in July 1992, the resulting set of guidelines and standards was adopted by the Academy of Laser Dentistry in 1993 and subsequently endorsed by more than 75 dental and health organizations, universities, and manufacturers worldwide. On October 3, 1998, a workshop was held at UCSF for a revision of the Curriculum Guidelines. Input was solicited from dental professionals who teach, use, or manufacture dental lasers through a consensus process. These guidelines establish standards of education for the demonstration of safe and effective use of lasers by dental professionals. The ALD has formally adopted the Curriculum Guidelines and Standards for Dental Laser Education. The Education Committee of the ALD regularly reviews and interprets these educational standards. The full document may be easily downloaded at: 5. SELECTED LASER DENTISTRY REFERENCES A reading list is available on the Academy of Laser Dentistry website at this link: 20Reading%20Materials 6. FDA MARKETING CLEARANCES The United States Food & Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture medical devices. FDA marketing clearances by device, procedure, and wavelength are available on request from the Academy. FDA Marketing Clearances by Indications for Use are listed in on the following pages. phone Regulatory Affairs Committee Information Packet for State Regulatory Boards 04_28_2014 Page 4

5 U.S. FDA Marketing Clearances by Indication for Use (Applies to Certain Models Only) Reprinted with permission from the Academy of Laser Dentistry and the Institute for Advanced Dental Technologies, February Intraoral Soft Tissue Surgery (Ablating, Incising, Excising, Coagulating) Ho:YAG Nd:YAP Er:YSGG -Pumped 2.01-micron Curing of Composite Materials Aphthous Ulcer Treatment Tooth Whitening phone Regulatory Affairs Committee Information Packet for State Regulatory Boards 04_28_2014 Page 5

6 Sulcular Debridement Er:YSGG Caries Removal, Cavity Preparation, Enamel Roughening Er:YSGG Illumination for Caries Detection Illumination for Endodontic Orifice Location Soften Gutta Percha Removal of Coronal Pulp, Adjunct to Root Canal Procedures Pulpotomy as Adjunct to Root Canal Procedures Nd:YAP Selective Removal of Enamel (First Degree) Caries Removal of Filling Materials as Adjunctive Treatment during Root Canal Retreatment Nd:YAP phone Regulatory Affairs Committee Information Packet for State Regulatory Boards 04_28_2014 Page 6

7 Aid in Diagnosis of Dental Caries Treatment of Herpetic Lesions Blood Flow Measurements Tooth Preparation to Obtain Access to Root Canal, Pulp Extirpation, Root Canal Debridement and Cleaning, Root Canal Preparation including Enlargement Enameloplasty, Excavation of Pits and Fissures for Placement of Sealants Cutting, Shaving, Contouring and Resection of Oral Osseous Tissues (Bone) Apicoectomy Surgery Coagulation of Extraction Sites Ostectomy, Osteotomy, Osseous Crown Lengthening, Osteoplasty phone Regulatory Affairs Committee Information Packet for State Regulatory Boards 04_28_2014 Page 7

8 Laser-Assisted New Attachment Procedure (cementum-mediated periodontal ligament newattachment to the root surface in the absence of long junctional epithelium) Cutting Bone to Prepare a Window Access to the Apex (Apices) of the Root(s) Root End Preparation for Retrofill Amalgam or Composite Reduction of Bacterial Level (Decontamination) and Inflammation Aid in Detection and Localization of Subgingival Dental Calculus Root Canal Disinfection after Endodontic Instrumentation Removal of Subgingival Calculi in Periodontal Pockets Removal of Highly Inflamed Edematous Tissue Affected by Bacterial Penetration of the Pocket Lining and Junctional Epithelium Removal of Pathological Tissues (i.e., Cysts, Neoplasm or Abscess) and Hyperplastic Tissues (i.e., Granulation Tissue) from around the Apex Er,Cr;YSGG phone Regulatory Affairs Committee Information Packet for State Regulatory Boards 04_28_2014 Page 8

9 Ablation of Hard Tissue for Caries Removal and Cavity Preparation Diagnostic Aid for Detection of Open or Incipient Caries Lesions Above the Gingiva and for Monitoring the Progress of Such Lesions, includes Detection of Cracks phone Regulatory Affairs Committee Information Packet for State Regulatory Boards 04_28_2014 Page 9