The meeting location is accessible to persons with disabilities. A request for an interpreter for the hearing impaired or for other accommodations for persons with disabilities should be made at least 48 hours before the meeting to Teresa Haynes, (971) 673-3200.

MEETING NOTICE

DENTAL IMPLANT SAFETY WORKGROUP

Oregon Board of Dentistry 1500 SW 1ST AVE

Suite 770 Portland, Oregon 97201

January 25, 2018 6:30 – 8:00 pm

Workgroup Members:

Gary Underhill, D.M.D., Co - Chair Julie Ann Smith, D.D.S., M.D., M.C.R., Co - Chair Todd Beck, D.M.D., OBD President Paul Kleinstub, D.D.S., M.S., Chief Investigator and Dental Director Daniel Blickenstaff, D.D.S., M.S.c., OBD Investigator James Katancik, D.D.S. - OHSU School of Dentistry designee S. Shane Samy, D.M.D. – ODA designee Normund K. Auzins, D.D.S. – ODA designee Cyrus B. Javadi, D.D.S. - Board Appointed Duy Anh Tran, D.M.D. - Board Appointed Russell A. Lieblick, D.M.D. - Board Appointed Donald Nimz, D.M.D. - Board Appointed

AGENDA Call to Order Gary Underhill, D.M.D., Co-Chair Julie Ann Smith, D.D.S., M.D., M.C.R., Co-Chair

• Welcome & Review Agenda • Introductions • Review & Approve Minutes from Workgroup Meeting on September 28, 2017 • Responses from ADEX and regional testing agencies • Review & Discuss Recommendations Submitted by Workgroup Members • Open Floor- Comments from Visitors • Next Steps

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September 26, 2017 Dental Implant Safety Workgroup Page 1 of 2

Oregon Board of DentistryDental Implant Safety Workgroup

Minutes

September 28, 2017

MEMBERS PRESENT: Gary Underhill, D.M.D., Co – Chair Julie Ann Smith, D.D.S., M.D., M.C.R., Co – Chair Todd Beck, D.M.D., Board Member Paul Kleinstub, D.D.S., M.S., Dental Director/Chief Investigator Daniel Blickenstaff, D.D.S., M.S.c., Investigator James Katancik, D.D.S. – OHSU School of Dentistry designee S. Shane Samy, D.M.D. – ODA designee Cyrus B. Javadi, D.D.S. – Board Appointed Duy Anh Tran, D.M.D. – Board Appointed Russell A. Lieblick, D.M.D. – Board Appointed Donald Nimz, D.M.D. – Board Appointed

STAFF PRESENT: Stephen Prisby, Executive Director Teresa Haynes, Office Manager Haley Robinson, Investigator

ALSO PRESENT: Alton Harvey, Sr., Board Member; Lori Lindley, Sr. Assistant Attorney General

VISITORS PRESENT: Laurie M. Hesla, D.M.D., Ian A. Pham, D.M.D., James A. Miller, D.M.D., Duane T. Starr, D.M.D., Frank Stroud, D.D.S., Vaughn Tidwell, D.M.D.

The meeting was called to order by Dr. Smith at 6:00 p.m. Dr. Smith welcomed everyone and had those present introduce themselves.

Dr. Smith reviewed the agenda and the initial attachments regarding discipline and case data. There was general discussion and OBD Investigator, Dr. Blickenstaff, shared the staff’s experience with investigations. It was noted that both general practitioners and specialists were disciplined similarly, about 40% of dental implant cases ended up with discipline. The implant cases reviewed represented approximately 10% of all cases the Board reviewed.

Dr. Underhill presented information gathered from multiple sources including specialists, dental supply companies and dental laboratories. Common concerns that Dr. Underhill found in his research were the many different brands and types of implants available. It can be very difficult to find the correct parts to restore implants if the brand is not documented in the patient records. Dr. Underhill also stated that many of the implant courses being offered are through implant manufacturers themselves. He noted that this may result in the companies pushing their product, rather than focusing on educating the providers.

Key Discussion Points

Proper treatment planning is critical to the success of dental implants. Whether restrictions or additional certifications should be put in place to ensure the

safety of the public.

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September 26, 2017 Dental Implant Safety Workgroup Page 2 of 2

Continuing education related to dental implants. The importance of the restorative component as well as proper implant placement and

post-operative care. The investment and return on providing dental implants to patients in relation to patient

care and cost effectiveness. Proper management and referral of treatment complications.

Audience members were encouraged to address the OBD Dr. Vaughn Tidwell, Director of Implant Resource Center, discussed his program where he holds the membership to twelve doctors. The members must first learn and pass an examination understanding the science behind osseointegration, The members then spend the next six months learning to treatment plan. The members are not allowed to place a single implant without first coming to him and having his approval; after going over all the treatment plans, 30% of the cases are refused. This program makes sure the students are prepared to place implants. Dr. James Miller voiced his support of the workgroup and felt that all practitioners who are placing implants need to think about what they are going to do and treatment plan from the beginning to end of treatment. Dr. Smith asked for suggestions for the next Workgroup meeting. The topics suggested for the next meeting included: educational requirement for dental implants, what certification maintenance would be required to be able to continue to place implants, how the Board is going to document for the public information on who have completed required education, and also suggested protocols for those licensees who are placing implants. Dr. Smith and Dr. Underhill directed workgroup members to generate possible solutions to address dental implant safety. Workgroup members were encouraged to send any information to Executive Director, Stephen Prisby. The Board will correspond with members of the workgroup via email to set a future meeting date. The meeting was adjourned at 8:01 pm.

Response to request for information from ADEX and the Five (5) Regional Testing Agencies

ADEX (American Board of Dental Examiners, Inc.) • “The current ADEX Dental Examination currently has some questions

related to dental implants on the DSCE OSCE computer based examination.

However, ADEX is about to undertake a new Occupational Analysis which is done every 5 to 7 years to make sure that the examination is current. The Occupational Analysis will be this fall or early winter and the results of that Occupational Analysis will determine what items will be tested on future ADEX Dental Examinations.

If changes are made to the ADEX Dental Examination in the placement of dental implants as states that accept the ADEX Dental Examination would be notified.

Since the Oregon Board of Dentistry (OBD) is an ADEX Member State, who has a representative on the ADEX Dental Examination Committee, the OBD would play a role in that decision.”

CDCA (Commission on Dental Competency Assessments) • “ Yes, all relevant information we will be able to provide is via ADEX. We’ve contributed

funds supporting ADEX’s occupational analysis and report which we believe will comment on these topics. This will report will inform any changes that result in any related ADEX exam committee recommendations at next year’s ADEX meeting. Of course, Oregon Board of Dentistry is represented at this ADEX meeting as a contributing member of ADEX.”

CITA (Council of Interstate Testing Services, Inc.) • “CITA relies on ADEX’s response.”

CRDTS (Central Regional Dental Testing Services, Inc.) • “Since the placement of dental implants is largely conducted by specialists, we do not

have any development plans for the testing of this procedure/skill set.”

SRTA (Southern Regional Testing Agency) • “We currently do not test how the placement of dental implants are done, however, have

added this topic for our Dental Examination Committee and Board of Directors to discuss later this month.”

WREB (Western Regional Examining Board) • “WREB has been testing implants on our dental exam since 2015. This subject matter is

tested in our Comprehensive Treatment Planning exam, which is a required section of the exam.” Exhibit #1

1

CoMprehenSive TreaTMenT planning

Examination Overview

The Comprehensive Treatment Planning (CTP) examination is a computer-based examination administered by Prometric test centers. The exam consists of three (3) patient cases of varying complexity, one of which is a pediatric patient. For each case, Candidates assess patient history, photographs, radiographs, and clinical information, create and submit a treatment plan, and then answer questions or perform tasks related to each case. Candidates are allowed three (3) hours to complete the CTP exam. A 15 minute tutorial is provided prior to the beginning of the examination.

Communication at any time with other individuals regarding the contents of the CTP examination is considered unethical conduct. If a Candidate engages in Improper Performance or Unethical Conduct, in addition to dismissal from the exam, failure of the exam, or reduction in an exam score, WREB reserves the right to take any other reasonable action WREB deems appropriate, including, but not limited to reporting the Candidate to: (i) the various state licensing boards, (ii) the Candidate’s dental school, (iii) other dental or dental hygiene testing organizations or (iv) other professional organizations.

For each patient case, the following will be provided:

• Personal Profile that provides a brief overview of the patient• Patient Information form• Medical History• Dental Chart indicating existing restorations • Periodontal Chart, for adult patients, highlighting key periodontal findings• Photographs showing intraoral and extraoral images of the patient• Intra and/or extraoral radiographs• Clinical findings, located at the bottom of the medical history form, indicating conditions that

may not be clearly demonstrated in the images but would be found during a patient examination

Also provided:

• The CTP Candidate Guide• Space for recording the Candidate’s Treatment Plan submission• Space for recording the Candidate’s answers to specific case questions

Test Content

The CTP examination is designed to integrate the various disciplines of dentistry as done in actual practice. The following list indicates the major areas of dentistry that are tested on the exam:

• Restorative Treatment• Single Units/Operative• Multiple Units

• Fixed Prosthodontics• Interim Restorations

Exhibit #1

2

• Removable Prosthodontics• Partial Dentures• Complete Dentures• Implant-Supported Restorations

• Periodontal Treatment• Phase I (Non- Surgical) Therapy• Re-evaluation• Surgery/referral• Maintenance

• Endodontic Treatment• Surgery

• Exodontia• Pre-prosthodontic• Periodontal• Implant Placement

• Prescription Writing• Pharmacy• Dental Laboratory

• Follow-up/Prognosis/Maintenance

Diagnosis, Etiology and Treatment Planning are integrated throughout the exam and overlap the test specifications listed above. Also included are principles of pediatric dentistry, orthodontics, pharmacology, and specialist referrals when appropriate.

Treatment Plans

The Candidate is required to develop a complete treatment plan for each assigned patient case. The treatment plan can be edited or modified until final submission. After final submission the treatment plan will be available for review only; no further changes can be made. Following submission of the treatment plan, additional questions or tasks related to the treatment of the patient become accessible. The treatment plan submitted by the candidate will be available for review while navigating through these additional items, but cannot be modified.

The treatment plan must:

• Appropriately address the patient’s chief complaint or concern.• Include appropriate treatment modifications if there are medical conditions that may affect the

delivery of dental care. If medications are required, the plan must include drug, dose, and directions for use.

• Recommend additional diagnostic tests or specialist referrals as part of the treatment plan, if indicated. If referring to a specialist, a diagnosis and proposed treatment must be indicated.

• Contain a comprehensive and appropriately sequenced list of procedures that address the patient’s dental needs.

• Be succinct, organized, and readily interpreted.

Exhibit #1

Recommendations from Dr Paul Kleinstub and Dr. Daniel Blickenstaff for the Workgroup

The Board of Dentistry should pass a rule stating that in order for a dentist to place implants, he/she must first complete a minimum of XXX hours in a hands on clinical course(s), which includes the placement of XX implants under direct supervision, and the provider is approved by the Academy of General Dentistry Program Approval for Continuing Education (AGD PACE) or by the American Dental Association Continuing Education Recognition Program (ADA CERP).

Dr. Javadi's Recommendations 1

Recommendations from Dr. Javadi for Implant Safety Workgroup

Suggestions

1. Public safety related to dental implants is the primary concern. Safety, asused here, is defined as the reasonable expectation that the dentist ispracticing in a manner that will significantly improve the successfuloutcome of the dental implant procedure.

2. Dentists should have sufficient didactic knowledge and clinical experiencein the treatment planning of, surgical placement of, restoration of, andmanagement of complications related to dental implants.

3. Other dental related practices such as Conscious sedation, Botox andDermal fillers, should be considered as models because these proceduresare currently regulated by the Oregon Board of Dentistry.

4. All dentists, regardless of specialty, should be permitted to provide implant related procedures assuming that they have the appropriate knowledgeand experience.

Recommendations from Dr. Russell Lieblick for the Workgroup Background: Implantology has become a major safety concern for patients in Oregon. While the general dentistry model allows dentists to perform these procedures under their licenses, placement of a dental implant is indeed a surgical procedure. The surgery is relatively simple in concept, but proper execution is difficult and requires significant surgical skill as well as in-depth training for the myriad of complications that can arise. Complications can range from non-integration to infections and disfiguring bone loss to life-threatening bleeding issues. General dentists, in most cases, are simply not trained to evaluate and treat these complications. Furthermore, poor placement and poor treatment planning tend to be a continuous problem in these cases. Finally, the problem is much greater than has been reported to the Board. Most of the cases do not get reported. As was discussed in our workgroup meeting, there are several obstacles to creating rules that allow the board to have a substantive way to limit those who are untrained from doing the procedures. In the hospital setting, privileges must be earned to be able to perform a procedure. A committee weighs the documentation of the proposed expertise and determines whether they will allow the surgeon to perform the procedure at their hospital. This is obviously not possible in this situation due to the general dentistry model and the public nature of the privilege allowance or disallowance. Also discussed in the meeting was creating a barrier of entry to surgical placement by creating necessary education requirements. Initially, this is very appealing. An oral and maxillofacial surgeon must have education via fellowship training prior to performing cosmetic surgery. This barrier of entry is difficult, but a significant dedication must be made to attaining fellowship training and the surgeon is highly vetted prior to acceptance. Therefore, he or she is most likely a good candidate to perform the procedures following training. However, an educational requirement prior to dental implant placement, aside from residency, is much more problematic. Dentists may undergo very expensive training with questionable efficacy only to find out that they are not well suited to placement of implants. The expense and possibly the temperament of the dentist then becomes a barrier to exit that is way too high, forcing them to continue to provide a procedure that they are ill-suited to perform. In addition to these objections is the concern on teaching methodology. I intend in no way to disrespect the other committee members, but it occurred to me during the meeting that the teaching methods described are flawed in an important way. As reported, participants in one teaching course were instructed to extract teeth and graft the sockets to learn grafting techniques prior to placing an implant. They were to only extract the teeth and graft. Is that what was needed? In most cases the implant can be placed at the time of the extraction without a graft at all. Was the implantologist in training providing unnecessary treatment for the sake of training? I would not dare say that this is true, but this is dangerous ground. Finally, an educational requirement would create a market for CE providers to train more dentists to place implants. They would encourage many who would not otherwise venture into the surgical aspect to do so and create more implantologists, not less. Another person at the meeting mentioned that he trains dentists never to do an implant without cone beam computed tomography (CBCT). This is also a red flag in my mind as many implants do not require this type of radiography and exposes patients to unnecessary radiation. Clearly CBCT has it’s place, but is not necessary in every case.

Finally, the argument that implantologists are needed is flawed. There are enough specialists in oral surgery and periodontics to provide implants to all of the patients who want/need them. There is no crisis with access to care. Costs are also an over-inflated argument. As a surgeon I have studied the market extensively and many surgeons place implants for less cost than an implantologist due to less procedures, less time off of work, etc. Recommendations: In order to provide full disclosure, I believe that I should explain my perspective as a signifiant part of my recommendations. As a surgeon who places many implants and sees many cases that must be revised/redone/reconstructed, I believe that if the board was capable of placing dental implant treatment solely in the hands of specialists, this would be the best possible outcome. However, I am not recommending this course as I don’t see that it fits ALL circumstances. My recommendations are two-fold:

1. I believe the burden to provide an informed consent prior to the procedure is the most important protection for patients. This must be a TRUE informed consent. For a dentist who is in training and is instructed to place bone grafts, he must inform the patient of this along with the alternative to see a specialist and potentially have the tooth removed and the implant placed the same day without further procedures. The dentist who is placing dental implants must inform the patient that there is an option to see a specialist who has surgical training and more experience than they do. To simply tell a patient that they are capable and either state or imply that they are as experienced and capable as a surgeon is entirely misleading. This informed consent should require more than “PARQ” in a chart. It should be spelled out and signed by the patient. After that, it is the patient’s responsibility to understand the risks as well as the alternative to seek care from a specialist. The dentist must refer to a specialist if the patient would like additional information, a second opinion or treatment by a specialist. A directive by the board to complete a fully detailed informed consent with patient initials by each line is only a slight rule change that provides transparency in the informed consent process. The board already has rules with significant accountability for informed consent. I believe that enforcing informed consent to the greatest extent is the most non-intrusive between doctor and patient and provides the most protection without heavy-handed regulations.

2. To satisfy the treatment planning concerns that tend to be a major issue with implantologists’ cases, a directive requiring the restoration of 100 implants prior to placing one would be worthwhile. It would require that the dentist works with a specialist who can help guide treatment planning. It would not cost the dentist heavy CE fees and create awareness of both the restorative and surgical aspects of implant treatment planning.

Thank you for reviewing the above recommendations. I look forward to reviewing the recommendations of the other committee members.

Recommendations from Dr. Donald Nimz ODB Implant safety committee. My thoughts on requirements for certification for implant placement for general dentists: 50 hours of implant related continuing education, including a minimum of five hours Clinical participation. Personally I spent over 10 years restoring implants placed by oral surgeons Dr Tenhulzen and Dr Richmond and Humble, before placing any implants myself. Restoring implants gives you insight to all the complications and difficulties of implant restoration as well as placement. With that understanding of where I came from where I am today I would suggest the placement of a minimum of 20 crowns on implants placed by a specialist or certified dentist.

Donald Nimz DMD PC

www.oregondentist.com American Dental Association, Academy of General Dentistry American Academy of Cosmetic Dentistry American Academy of Implant Dentistry (503) 654-9565 16230 SE McLoughlin Blvd. Milwaukie, OR 97267

OBD-Dental Implant Safety Workgroup Meeting #2 January 25, 2018 @6:30 pm

In Consideration of 818-012-0005 Scope of Practice + 818-012-0010 Unacceptable Patient Care Clarifying question Does the Oregon Dental Practice Act have any provisions regarding introduction of new technology and / or procedure(s) into a licensee's practice or skill level ?

Example: a licensee who graduated in 1970's was probably not introduced to posterior composite restorations nor trained (assumption).... .....how does this licensee develop the skill and knowledge to introduce posterior composite restorations to his / her practice / patients ? (it's certainly within the scope of dentistry and is acceptable patient care) Discussion: -this same concept can be applied to any new technology and / or procedure(s)

-how many dentist are purchasing 3D cone beam technology? and are they trained to read and interpret these scans / images ? -it's obvious that every licensee has different set of skill levels and knowledge base, as professionals how are they guided to learn and "keep up" to serve their patients ?... does alternative education count ? (Videos, Webcast) - Treatment planning and education seem to be a common thread that is missing in providing dental implant treatment for an individual (patient) -What if licensees are required to document a complete dental diagnosis prior to providing either "any" or "surgical" procedure which involves dental implants (both restorative and surgical aspects of the treatment) -If a licensee is going to provide the surgical aspect of the dental implant procedure then he / she must have __X__amount CE hours of live surgical experience (i.e. direct supervision) prior to performing such procedure(s) Considerations: the above can be enforced multiple ways....here is a suggestion:

...."if" there is a complaint filed and / or if the licensee is audited and the above criteria is not met then the licensee will have limitations placed on their license to practice dentistry until he / she completes a ___X ____ amount of CE hours to satisfy the above OBD is establishing guidelines for dental implant procedures and if these guidelines are not met then licensee's risk losing the privilege to provide such services until they can demonstrate competence in providing noted treatment the above allows the market to self correct by increasing the risk to the licensee who is not prepared to provide such procedure We should also clarify that in accordance to 818-012-0005 restorative only practitioners can market "implants restored' and surgical only can market "implants placed" and only those doing both sides can market "implants', etc. my thoughts for discussion only respectfully submitted, Shane Samy D.M.D.

Dr. Duy Anh Tran’s Recommendations for the Workgroup

HI Stephen,

My recommendation for dentist who have not been through a specialty program will need to take continue education involving dental implant every license renewal cycle. The amount of CE hours can negotiable amongst the panel (6-10 hours is probably not too much to ask for those who wants to place implants).

I look at this very similar to those who have minimal, moderate, or general sedation licenses. Sedation dentistry can change over time for example ACLS and PALS certification. Implant dentistry is no different, Every couple of years new methods and research changes the way we update our surgical techniques.

Beyond this I can't see anything else that you can limit a dentist to have the ability to practice. I would sure hope someone wanting to do the best in their careers would go above and beyond the minimum requirement to train themselves.

As far as dentist who have demonstrated the inability to perform standard of care surgical technique, I recommend mentorship programs or a accredited mini residencies if they want to continue placing dental implants. There are several national groups like the AO and the ICOI that offer different surgical tracks and restorative track that general dentist can take courses and get involved in. After they have completed the courses recommended then implants can be complete and reviewed by a in town mentor or a select group of mentor.

Thanks for your help in gathering this information.

Sincerely, Duy Anh