When risk influences treatment
Personalized care takes into account various risk factors
Personalized care takes into account various risk factors
BY KAREN DAVIS, RDH, BSDH
What does the term "personalized medicine" or "personalized care" mean to you?
Have you undergone genetic testing to determine if you carry the BRCA1 or BRCA2 gene mutation that increases the risk of breast and ovarian cancer? If your blood work tomorrow revealed you were "pre-diabetic," would that significantly impact your dietary choices or physical activity? What about your patients? If a simple test revealed that your patient was at increased risk for severe periodontal disease based on their genetics, would it alter the course of treatment? Would knowledge that a person had quantifiable risks for periodontal infection enable you to assist in preventing disease initiation?
Interesting questions. Perhaps now is a good time to consider how personalized care might impact you and your patients. The term "personalized medicine" has garnered a great deal of attention in the media recently, but what does it really mean? The National Institute of Health has defined it as "the science of individualized prevention and therapy." It's happening in medicine and it's coming to dentistry, and the potential impact is huge.
Personalized medicine today
Let's consider a couple of examples: one outside of dentistry and one within. Let's say that tomorrow you or a loved one is diagnosed with breast cancer. In an effort to make the best treatment decisions surrounding chemotherapy, potential radiation, or even mastectomy, you elect to have the BRCA testing to discover if you carry the genetic mutation increasing the risk of ovarian cancer in addition to breast cancer. The results of the genetic test have a potential impact not only on your path of treatment, but (if the test is positive) a potentially huge impact for your children or siblings who may also be at an increased risk for breast and ovarian cancer.
In this real-world example, risk assessment empowers decision making regarding prevention and treatment options for both patient and provider - truly "individualized prevention and therapy" in action.
Now let's say that tomorrow your patient presents with a history of cigarette smoking, type 2 diabetes, and a history of high blood pressure and high cholesterol. Clinically, they present with moderately good oral hygiene and have a history of visiting the dental hygienist once or twice a year. Their pocket depths are 1-4mm with light bleeding upon scaling. Radiographically, they have slight crestal bone loss in localized areas. Additionally, they are Interleukin-1 (IL-1) genotype positive - a genetic variation which causes a heightened inflammatory response, leading to increased bone and connective tissue destruction in periodontal tissues.
How do you personalize the care for this patient? Imagine that this patient had insurance benefits that increased his preventive care from twice a year to four times a year based upon his risks. Would it be possible to intervene and prevent permanent periodontal destruction? Most clinicians would agree that this patient needs nonsurgical therapy once the 4mm pockets become 5mm pockets, and the bleeding becomes more generalized. But what if there were a model that supported earlier intervention, disease prevention, and modifications based upon identifying risks?
Surprising results from study
Recently the University of Michigan Personalized Prevention Study1 (MPPS) shed light on facts that may surprise dental professionals, but should make all of us consider the opportunity that exists. Throughout the past 50 years, tradition and insurance reimbursement have primarily driven the frequency of preventive visits to the dental office above any evidence-based data supporting a six-month interval opposed to any other interval.
In the MPPS, dental insurance claims of more than 5,000 patients were evaluated for a 16-year period and they were retrospectively analyzed for the risk of tooth loss based upon preventive visit frequency once or twice annually. They were further analyzed based upon: no major risk for periodontal disease, low risk, or high risk dependent upon smoking, diabetes and being Interleukin-1 genotype positive. In this risk-based model, 42% of patients analyzed had one risk factor for periodontal disease, 10% had two or more and 47% had none of these three risk factors for periodontal disease. Data was evaluated to determine the frequency of tooth loss based upon the frequency of preventive visits and the number of risk factors for periodontal disease, the major cause of tooth loss in adults. The results of the study were somewhat surprising:
• For patients with no major risk factors, two prophylaxes per year did not result in significant reduction in tooth loss compared to one prophylaxis.
• For patients with one or more risk factors, two prophylaxes added significant value in the reduction of tooth loss.
• For patients with two or more major risk factors, two prophylaxes were not adequate to control tooth loss.
Another unexpected finding from the study was that genetic variation (30% of those tested) was the most common risk factor for heightened risk of periodontal disease, even more than smoking (18%) and diabetes (10%) combined.
Translating data into dental reality
This study, coupled with the incidence of periodontal disease equaling almost 50% of the U.S. population2, begs the question: Is it time to do something different? What about utilizing risk as a guide for intervention and personalizing the care before disease initiation or progression? The MPPS provides a model for aligning risk assessment with a customized preventive interval. This type of a platform presents an opportunity to personalize intervention treatment for patients at the highest risks for periodontal disease and eventual tooth loss by increasing their preventive care visits. Basically, the greater the risks, the more frequently preventive care would be rendered.
But those of us in the dental profession recognize the significant influence third party reimbursement has upon the frequency patients actually participate in preventive care. So, what if reimbursement were correlated to identifiable risks for periodontal disease rather than tradition or habit? Could you call that personalized dental care?
From the standpoint of the third-party payers, providing plans that increase benefits prior to significant disease destruction for those with the highest risks holds the promise of significant cost savings. Wouldn't all dental professionals support this concept? Well, not exactly. Not yet. Let's examine why.
Beginning in 2013, Delta Dental offered the opportunity for members in a few states to participate in personalizing their own benefit plan by electing to complete a periodontal risk assessment questionnaire and submitting a genetic sample via cheek swab that would identify if the patient had inherited the IL-1 gene.3 Multiple studies support a significant link between IL-1 gene variations and periodontitis development and progression.4,5,6,7,8,9
In this initial roll out, if patients elected not to complete the periodontal assessment or take the genetic risk test or if their risk assessment proved normal risk for periodontal diseases, their basic benefit plan would include two dental examinations and one preventive cleaning annually. Patients with a history of periodontal disease would receive additional preventive/maintenance visits up to a maximum of four per year. For those who either had or were at risk of periodontal disease based upon existence of specific risk factors such as diabetes, history of stroke or heart attack, renal failure or dialysis, suppressed immune system, radiation treatments to the head and neck due to cancer, or pregnancy, their plan would increase benefits for additional preventive visits up to a maximum of four per year. This model also included reimbursement for the cost of the genetic risk test as well as its administration to the patient.
Some dental professionals have concern that those with the lowest risks would negatively impact the profitability of the dental practice since this type of model provides a basic benefit for one preventive visit annually. Is that a legitimate concern? Well, keep in mind that the only study to date that has quantitatively evaluated various risk factors for periodontal disease, the MPPS, revealed that 53% of patients had one or more major risk factors for periodontal disease and 47% had none of the major risk factors of smoking, type 2 diabetes, or IL-1 genotype positive. Those with one or more risk factors would be eligible for more frequent preventive care, offsetting those with the lowest risk and less preventive benefit.
Another surprising finding from the MPPS study was that less than 50% of the more than 5,000 patients followed for 16 years of dental claim analysis averaged preventive visits two times per year. Slightly more than 50% averaged only one to one and a half visits per year.1 While these numbers may or may not be reflective of preventive visits in your practice, the message from this data is that approximately 50% of the patients were at heightened risk, and approximately 50% did not participate in regular preventive care. Certainly an opportunity exists for increasing personalized preventive care.
Is it possible for a risk-based model for personalized preventive care to be more profitable than the current model most dental practices experience? It is not only possible, but also probable (extrapolating the data from the MPPS study) if dental practitioners are willing to embrace a risk-based approach to care. Of equal importance are the clinical benefits to patients, namely the potential to intervene with personalized care sooner as opposed to later in the disease process. Not wanting to oversimplify the process for this type of a change to have a hugely positive impact upon the profession and the health of dental patients, certainly patients would need to be educated regarding the value of participating in risk assessments, and third-party payers would need to provide increased preventive benefits for increased risks. There is a model in place, and the process has already begun in some states.
Shifting our comfort, our paradigms, and our protocols goes against human nature, which opts for the status quo, but the following question remains. Are we doing the best we can to diagnose, intervene, and prevent destructive periodontal diseases from impacting almost 50% of the U.S. population? Perhaps it is time to carefully consider a model that mirrors the direction medicine is going, one based upon the science of individualized prevention and therapy for dental patients. Evidence-based decision making for customizing prevention and intervention of periodontal diseases is a huge opportunity. Are you ready?
KAREN DAVIS, RDH, BSDH, is the founder of Cutting Edge Concepts, an international continuing education company, and practices dental hygiene in Dallas, Texas. She is an independent consultant to the Philips Corp., Interleukin Genetics, and Periosciences, and she serves on the review board for Dental-antioxidants.com. She can be reached at Karen@Karendavis.net.
1. Giannobile WV, Braun TM, Caplis AK, Doucette-Stamm L, Duff GW Kornman KS. Patient stratification for preventive care in dentistry. J Dent Res. 2013;92(8):694-701.
2. Periodontitis among adults aged >30 years - United States 2009-2010. Centers for Disease Control and Prevention. www.cdc.gov. Accessed June 2014.
3. PerioPredict™ Genetics Risk Test Interleukin Genetics, Inc.
4. Kornman KS, Crane A, Wang HY, di Giovine FS, Newman MG, Pirk FW, et al. (1997). The interleukin-1 genotype as a severity factor in adult periodontal disease. J Clin Periodontol. 1997;24:72-77.
5. McDevitt MJ, Wang HY, Knobelman C, et al. Interleukin-1 genetic association with periodontitis in clinical practice. J Periodontol. 2000;71:156-163.
6. Lang NP, Tonetti MS, Suter J, Sorrell J, Duff GW, Kornman KS. Effect of interleukin-1 gene polymorphisms on gingival inflammation assessed by bleeding on probing in a periodontal maintenance population. J Periodontal Res. 2000;35(2):102-7.
7. Nikolopoulos GK, Dimou NL, Hamodrakas SJ, Bagos PG.Cytokine gene polymorphisms in periodontal disease: a meta-analysis of 53 studies including 4178 cases and 4590 controls. J Clin Periodontol. 2008;35(9):754-67.
8. Grigoriadou ME, Koutayas SO, Madianos PN, Strub JR. Interleukin-1 as a genetic marker for periodontitis: review of the literature. Quintessence Int. 2010;41(6):517-525.
9. Karimbux NY, Saraiya VM, Elangovan S, Allareddy V, Kinnunen T, Kornman KS, et al. Interleukin-1 gene polymorphisms and chronic periodontitis in adult whites: a systematic review and meta- analysis. J Periodontol. 2012;83:1407-1419.
10. MyPerioID Oral DNA Laboratories, Inc.
Integrating periodontal risk assessments into clinical protocols
Integrating periodontal risk assessments does not need to be any more cumbersome than an effective caries management by risk assessment (CAMBRA) that many professionals already embrace. Salivary samples can be collected chairside with either a cheek swab3 or following a saline rinse.10 With the periodontal risk test, DNA samples are secured and mailed to the laboratory for analysis to determine the presence of genetic variations implicated in periodontal diseases.
Let's return to the hypothetical patient mentioned in the main article that presents tomorrow with a history of tobacco use and diabetes. Let's call him Joe. Using the personalized care model described in this article, the dental hygienist could perform a genetic risk test for Joe, send it to the lab confirming he has an increased risk for periodontal disease due to a genotype variation.
The presence of multiple risk factors would be the basis for Joe's dental insurance to increase preventive benefits to four times per year enabling the clinician to help interrupt the early development of periodontal disease for Joe and potentially be involved in tobacco cessation support. Joe is already familiar with "early intervention" protocols in medicine having agreed to have colonoscopies every three years due to a family history of colon cancer, and prostate-specific antigen (PSA) testing annually due to a family history of prostate cancer. The model for personalized preventive dental care presented to Joe makes sense. Which of us wouldn't want to have more patients that value a personalized approach to patient care?