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This study is one component of a program to improve the maintenance of good dental health and the prevention of disease by use of risk stratification methods to efficiently guide increased preventive services to adult dental patients who are at increased risk for the major dental diseases, caries and adult periodontitis.
The investigators will use a retrospective cohort model to analyze a large dental claims database to determine if the frequency of preventive services influenced the periodontal disease outcomes and to determine if periodontal risk assessment information can be used to stratify dental patients into "high risk" and "low risk" categories that influence the effect of preventive services on periodontitis outcomes.
Primary Objective To evaluate whether dental patients who are classified as "low risk" for periodontal disease progression, based on history of periodontitis (claims history), smoking, diabetes, and IL-1 genetic variations, have different primary and secondary endpoints if they had two dental cleanings per year compared to one cleaning per year.
Secondary Objectives To evaluate whether dental patients who are classified as "high risk" for periodontal disease progression, based on a history of periodontitis, smoking, diabetes, and IL-1 genetic variations, have different primary and secondary endpoints if they had two dental cleanings per year compared to one cleaning per year.
To evaluate whether dental patients who have had one dental cleaning per year have different primary and secondary endpoints if they are classified as "low risk" for periodontal disease compared to patients who are classified as "high risk." To evaluate whether dental patients who have had two dental cleaning per year have different primary and secondary endpoints if they are classified as "low risk" for periodontal disease compared to patients who are classified as "high risk."
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Risk Experimental Group | 1 visit - Low Risk ~1200 subjects - Low Risk Experimental Group = 1 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-) | ||
| Low risk Control Group | 2 visits - Low Risk ~1200 subjects - Low risk Control Group = 2 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-) | ||
| High Risk Experimental Group | 1 visit - High Risk ~800 subjects High Risk Experimental Group = 1 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+) | ||
| High Risk Control Group | 2 visits - High Risk ~800 subjects High Risk Control Group = 2 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+) |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Tooth Loss Over 16 Year Period | Tooth loss rate over 16 years was calculated as the cumulative percentage of participants with tooth loss over 16 years. | 16 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Dental Claims During Monitoring Period | 10 and 15 years | |
| Change in Total Periodontal Claims During the Monitoring Period | 10 and 15 years | |
| Change in Periodontal Surgery Claims |
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Inclusion Criteria:
Exclusion Criteria:
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Study may include all participants who are 34-55 years old in 1992 (48-68 years old in 2010) and who have at least a 15-year dental claim history with Delta Dental.
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| Name | Affiliation | Role |
|---|---|---|
| William V Giannobile, DDS, DMedSc | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michigan Center for Oral Health Research | Ann Arbor | Michigan | 48106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23752171 | Result | Giannobile WV, Braun TM, Caplis AK, Doucette-Stamm L, Duff GW, Kornman KS. Patient stratification for preventive care in dentistry. J Dent Res. 2013 Aug;92(8):694-701. doi: 10.1177/0022034513492336. Epub 2013 Jun 10. |
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From 25,452 individuals meeting inclusion criteria, 9,927 (0.39 of eligible) consented to participate, and 5,117(0.515 of consented) returned completed questionnaires and were successfully genotyped.
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Risk Experimental Group | 1 visit - Low Risk 732 evaluable subjects - Low Risk Experimental Group = 1 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-) |
| FG001 | Low Risk Control Group | 2 visits - Low Risk 1,668 evaluable subjects - Low risk Control Group = 2 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-) |
| FG002 | High Risk Experimental Group | 1 visit - High Risk 852 evaluable subjects High Risk Experimental Group = 1 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+) |
| FG003 | High Risk Control Group | 2 visits - High Risk 1,847 evaluable subjects High Risk Control Group = 2 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
See Giannobile et al 2013 manuscript included
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Risk Experimental Group | 1 visit - Low Risk ~1200 subjects - Low Risk Experimental Group = 1 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-) |
| BG001 | Low Risk Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | The participants analyzed had to be within this age range during the year 2010. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Tooth Loss Over 16 Year Period | Tooth loss rate over 16 years was calculated as the cumulative percentage of participants with tooth loss over 16 years. | Posted | Number | percentage of participants | 16 years |
|
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This is an survey research study with the patient collection of their own biological specimen and the filling out of a survey to release their payer data (non-interventional).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Risk Experimental Group | 1 visit - Low Risk ~1200 subjects - Low Risk Experimental Group = 1 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Giannobile, Principal Investigator | University of Michigan | 734-764-1562 | wgiannob@umich.edu |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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buccal swabs
| 10 and 15 years |
| Change in Relationship of Risk Category & Tooth Loss Rate With Systemic Disease History on Questionnaire. | 10 and 15 years |
| Change in Evaluation for Dental Caries and Oral Cancer Within the Risk Categories | 10 and 15 years |
2 visits - Low Risk
~1200 subjects
- Low risk Control Group = 2 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)
| BG002 | High Risk Experimental Group | 1 visit - High Risk ~800 subjects High Risk Experimental Group = 1 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+) |
| BG003 | High Risk Control Group | 2 visits - High Risk ~800 subjects High Risk Control Group = 2 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+) |
| BG004 | Total | Total of all reporting groups |
| Number |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | High Risk Experimental Group | 1 visit - High Risk ~800 subjects High Risk Experimental Group = 1 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+) |
| OG003 | High Risk Control Group | 2 visits - High Risk ~800 subjects High Risk Control Group = 2 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+) |
|
|
| Secondary | Change in Total Dental Claims During Monitoring Period | Not Posted | 10 and 15 years |
| Secondary | Change in Total Periodontal Claims During the Monitoring Period | Not Posted | 10 and 15 years |
| Secondary | Change in Periodontal Surgery Claims | Not Posted | 10 and 15 years |
| Secondary | Change in Relationship of Risk Category & Tooth Loss Rate With Systemic Disease History on Questionnaire. | Not Posted | 10 and 15 years |
| Secondary | Change in Evaluation for Dental Caries and Oral Cancer Within the Risk Categories | Not Posted | 10 and 15 years |
| 0 |
| 732 |
| 0 |
| 732 |
| EG001 | Low Risk Control Group | 2 visits - Low Risk ~1200 subjects - Low risk Control Group = 2 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-) | 0 | 1,686 | 0 | 1,686 |
| EG002 | High Risk Experimental Group | 1 visit - High Risk ~800 subjects High Risk Experimental Group = 1 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+) | 0 | 852 | 0 | 852 |
| EG003 | High Risk Control Group | 2 visits - High Risk ~800 subjects High Risk Control Group = 2 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+) | 0 | 1,847 | 0 | 1,847 |
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