1. Periodontal Disease Risk Developed by PreViser, Inc. Courtesy PreViser Corporation, all rights reserved

2. Overview What is risk? What is risk? What are the clinical implications? What are the clinical implications? How is risk determined? How is risk determined? Courtesy PreViser Corporation, all rights reserved

3. What is Risk? General Context General Context The likelihood of suffering harm or loss The likelihood of suffering harm or loss Health Care Context Health Care Context The likelihood of a worse health status during the natural history of disease (risk) The likelihood of a worse health status during the natural history of disease (risk) The likelihood of an undesired treatment outcome (prognosis) The likelihood of an undesired treatment outcome (prognosis) Courtesy PreViser Corporation, all rights reserved

4. Risk, Diagnosis, and the Natural History of Disease Health Initial Stage Detectable Stage Moderate Disease Severe Disease Terminal Disease Risk predicts health status at a future time Diagnosis is a description of health status at the current time Courtesy PreViser Corporation, all rights reserved

5. Risk + Disease = 3 rd Dimension Risk-Disease Grid Health Status HealthMildSevere RiskLevel LowYesYesNo ModerateYesYesNo HighYesYesYes Courtesy PreViser Corporation, all rights reserved

6. Clinical Implications Health Initial Stage Detectable Stage Moderate Disease Severe Disease Terminal Disease Diagnosis is used to determine treatment for existing “visible” lesions (Reparative treatment) Courtesy PreViser Corporation, all rights reserved

7. Clinical Implications Health Initial Stage Detectable Stage Moderate Disease Severe Disease Terminal Disease Risk is used to: Justify treatment Modulate intensity and aggressiveness Determine treatment to prevent future lesions (Preventative treatment) Courtesy PreViser Corporation, all rights reserved

8. Justify Treatment ???? If everyone is low risk, then no one requires treatment, regardless of health status If everyone is low risk, then no one requires treatment, regardless of health status If everyone is high risk, then each patient needs the same preventative treatment and reparative treatment is based on the existing lesions If everyone is high risk, then each patient needs the same preventative treatment and reparative treatment is based on the existing lesions When risk for disease is stratified then treatment needs vary with those at high risk needing more care compared to those at low risk When risk for disease is stratified then treatment needs vary with those at high risk needing more care compared to those at low risk Courtesy PreViser Corporation, all rights reserved

9. Is Periodontal Disease Risk Stratified? Using the NHANES III database, Albandar, et al (J Periodontol 1999; 70: 13-29) reported the prevalence of Periodontitis in the adult population (30 years and older) Using the NHANES III database, Albandar, et al (J Periodontol 1999; 70: 13-29) reported the prevalence of Periodontitis in the adult population (30 years and older) 65% were Healthy 65% were Healthy 22% had Beginning Periodontitis 22% had Beginning Periodontitis 13% had Moderate to Severe Periodontitis 13% had Moderate to Severe Periodontitis When the same data is viewed by age cohort, … When the same data is viewed by age cohort, … Courtesy PreViser Corporation, all rights reserved

10. Periodontal Disease Risk 0 10 20 30 40 50 60 70 30-3435-3940-4445-4950-5455-5960-6465-6970-7475-7980-8485-90 Age Cohort % of Age Cohort Periodontitis Linear trend line Risk to remain healthy is 40% Risk for Periodontitis is 60% Courtesy PreViser Corporation, all rights reserved

11. Periodontal Disease Risk, cont. 0 5 10 15 20 25 30 35 40 45 30-3435-3940-4445-4950-5455-5960-6465-6970-7475-7980-8485-90 Age Cohort % of Age Cohort Linear trend line Moderate to Severe Periodontitis Beginning Periodontitis Risk for Beginning Periodontitis is 35% Risk for Moderate to Severe Periodontitis is 25% Courtesy PreViser Corporation, all rights reserved

12. Treatment Intensity and Aggressiveness An Example Treatment for a 75 year old patient with generalized 6 mm pockets may be limited to periodontal maintenance whereas surgery may be selected for a 35 year old patient with the same conditions when the risk level of the older patient is much lower than the younger patient. Courtesy PreViser Corporation, all rights reserved

13. Preventative Treatment Preventative treatment targets risk factors where risk factors are defined as, Preventative treatment targets risk factors where risk factors are defined as, An environmental, behavioral, or biologic factor, which if present directly increase the probability of a disease occurring, and if absent or removed reduces the probability. Risk factors are part of the causal chain, or expose the host to the causal chain. Once disease occurs, removal of a risk factor may not result in a cure. Beck, Community Dent Oral Epidemiol 1998 An environmental, behavioral, or biologic factor, which if present directly increase the probability of a disease occurring, and if absent or removed reduces the probability. Risk factors are part of the causal chain, or expose the host to the causal chain. Once disease occurs, removal of a risk factor may not result in a cure. Beck, Community Dent Oral Epidemiol 1998 Courtesy PreViser Corporation, all rights reserved

14. Preventative Treatment Health Initial Stage Detectable Stage Moderate Disease Severe Disease Terminal Disease Preventative treatment applied before detectable disease occurs or during another stage of disease that is reversible can prevent irreversible lesions that require reparative treatment. For example: Personal daily oral hygiene Periodontal maintenance care Courtesy PreViser Corporation, all rights reserved

15. Doomed by high risk? It is possible to be at high risk and not suffer the consequences of terminal disease by management of the risk factors. For example: It is possible to be at high risk and not suffer the consequences of terminal disease by management of the risk factors. For example: Daily personal oral hygiene for bacterial plaque Daily personal oral hygiene for bacterial plaque Smoking cessation Smoking cessation Blood-sugar control for diabetes Blood-sugar control for diabetes Periodontal surgery to eliminate pockets Periodontal surgery to eliminate pockets Courtesy PreViser Corporation, all rights reserved

16. How is Risk Determined? Subjective opinion, the current method, is highly variable leading to the conclusion that treatment may be misapplied for some patients, which is understandable since - Subjective opinion, the current method, is highly variable leading to the conclusion that treatment may be misapplied for some patients, which is understandable since - The professional literature provides a list of risk factors but no validated objective method to correlate multiple factors for clinical use The professional literature provides a list of risk factors but no validated objective method to correlate multiple factors for clinical use Courtesy PreViser Corporation, all rights reserved

17. Clinicians vs. OHIS™ Risk Assessment Study group of 107 patients with broad range of risk for periodontitis Study group of 107 patients with broad range of risk for periodontitis Full mouth periodontal charting Full mouth periodontal charting Medical and dental histories Medical and dental histories Full mouth periapical radiographs with bitewings Full mouth periapical radiographs with bitewings Clinical photographs Clinical photographs Persson GR et al. Assessing periodontal disease risk. J Am Dent Assoc 2003 Courtesy PreViser Corporation, all rights reserved

18. Clinicians’ vs. OHIS™ Risk Assessment, cont. 3 Groups of expert evaluators 3 Groups of expert evaluators 6 periodontists with national and international clinical, academic, and military experience 6 periodontists with national and international clinical, academic, and military experience 10 periodontists who participated in the development of the OHIS™ tool 10 periodontists who participated in the development of the OHIS™ tool 36 private practice general dentists who referred patients to periodontists 36 private practice general dentists who referred patients to periodontists Risk was assessed on a 1 (low) to 5 (high) scale by clinicians and OHIS™ Risk was assessed on a 1 (low) to 5 (high) scale by clinicians and OHIS™ Courtesy PreViser Corporation, all rights reserved

19. 107 Patient Records, Risk Assessed using OHIS™ Three Expert Groups Subjectively Assess Same Patients OHIS™ Courtesy PreViser Corporation, all rights reserved

20. 107 Patient Records, Risk Assessed using OHIS™ Three Expert Groups Subjectively Assess Same Patients 6 Practicing Experts OHIS™ Courtesy PreViser Corporation, all rights reserved

21. 107 Patient Records, Risk Assessed using OHIS™ Three Expert Groups Subjectively Assess Same Patients 6 Practicing Experts OHIS™ 10 PreViser Founders Courtesy PreViser Corporation, all rights reserved

22. 107 Patient Records, Risk Assessed using OHIS™ Three Expert Groups Subjectively Assess Same Patients 6 Practicing Experts OHIS™ 10 PreViser Founders 36 General Dentists “Periodontally Aware” Courtesy PreViser Corporation, all rights reserved

23. Risk Calculator Score = 3 General Dentist (5 Patient Evaluations… Expert Periodontists (5 Patient Evaluations per data point) Previser Founder’s (5 Patient Evaluations…) Practitioner evaluation over- estimating risk by 2 scores Practitioner evaluation under- estimating risk by 1 score Over- Estimated Risk = Inappropriate Treatment Under- Estimated Risk = Inappropriate Treatment Practitioner evaluation over- estimating risk by 1 score Practitioner evaluation under- estimating risk by 2 scores 20% Agreement with OHIS™ For OHIS™ assessed patients with Risk Score of 3.. Conclusion: Clinicians can’t assess the risk of future disease Courtesy PreViser Corporation, all rights reserved

24. Validity and Accuracy of OHIS™ Determined Risk 523 subjects enrolled in the Veterans Affairs Dental Longitudinal Study who had only routine care 523 subjects enrolled in the Veterans Affairs Dental Longitudinal Study who had only routine care Periodontal pocket depth measurements Periodontal pocket depth measurements Digitized full-mouth radiographs with bitewings Digitized full-mouth radiographs with bitewings Medical and dental histories Medical and dental histories Risk was assessed at baseline using OHIS™ Risk was assessed at baseline using OHIS™ Page et al. Validity and accuracy of a risk calculator in predicting periodontal disease. J Am Dent Assoc 2002 Page et al. Longitudinal validation of a risk calculator for periodontal disease. J Clin Periodontol 2003 Courtesy PreViser Corporation, all rights reserved

25. Validity and Accuracy of OHIS™ Determined Risk, cont. Changes in periodontal status determined by comparing baseline data to data at 3, 9, and 15 years Changes in periodontal status determined by comparing baseline data to data at 3, 9, and 15 years Alveolar bone loss (mean bone loss, percentage of sites with bone loss per subject) Alveolar bone loss (mean bone loss, percentage of sites with bone loss per subject) Tooth loss (mean percent tooth loss, percentage of subjects with tooth loss in each risk group) Tooth loss (mean percent tooth loss, percentage of subjects with tooth loss in each risk group) Courtesy PreViser Corporation, all rights reserved

26. Mean Bone Loss Risk 5 Risk 4 Risk 3 Risk 2 A measure of disease severity Courtesy PreViser Corporation, all rights reserved

27. Percentage of Sites with Bone Loss A measure of disease extent Courtesy PreViser Corporation, all rights reserved

28. 0.0% 5.0% 10.0% 15.0% 20.0% 25.0% 30.0% Year 3Year 9Year 15 Mean % (±SE) Tooth Loss Risk 5 Risk 4 Risk 3 Risk 2 Mean Tooth Loss Courtesy PreViser Corporation, all rights reserved

29. 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Year 3Year 9Year 15 % of subjects Risk 5 Risk 4 Risk 3 Risk 2 Percentage of Subjects with Tooth Loss Courtesy PreViser Corporation, all rights reserved

30. Summary Risk and disease are distinct entities that when combined provide a more comprehensive description of health status, which can be used to provide better care Risk and disease are distinct entities that when combined provide a more comprehensive description of health status, which can be used to provide better care Risk is determined from risk factors where diagnosis is determined from (“visible”) clinical signs and symptoms Risk is determined from risk factors where diagnosis is determined from (“visible”) clinical signs and symptoms Courtesy PreViser Corporation, all rights reserved

31. Summary, cont. Diagnosis leads to reparative treatment whereas risk guides preventive treatment and modulates treatment intensity and aggressiveness Diagnosis leads to reparative treatment whereas risk guides preventive treatment and modulates treatment intensity and aggressiveness Because the population is stratified by risk for periodontal disease, treatment should be customized based on a validated objective method that determines the unique risk level and disease status of each patient Because the population is stratified by risk for periodontal disease, treatment should be customized based on a validated objective method that determines the unique risk level and disease status of each patient Courtesy PreViser Corporation, all rights reserved