Periodontitis
Conditions
Keywords
periodontitis
Brief summary
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.
Interventions
None listed
Sponsors
University of Michigan
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
34 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* Organ transplant recipients are excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Tooth Loss Over 16 Year Period | 16 years | Tooth loss rate over 16 years was calculated as the cumulative percentage of participants with tooth loss over 16 years. |
Secondary
| Measure | 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 | 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 |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 (-) | 732 |
| 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 (-) | 1,686 |
| 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 (+) | 852 |
| 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 (+) | 1,847 |
| Total | 5,117 |
Baseline characteristics
| Characteristic | Low Risk Experimental Group | Low Risk Control Group | High Risk Experimental Group | High Risk Control Group | Total |
|---|---|---|---|---|---|
| Age, Customized >34 and < 55 years | 732 participants | 1686 participants | 852 participants | 1847 participants | 5117 participants |
| Region of Enrollment United States | 732 participants | 1686 participants | 852 participants | 1847 participants | 5117 participants |
| Sex: Female, Male Female | 461 Participants | 1130 Participants | 537 Participants | 1238 Participants | 3366 Participants |
| Sex: Female, Male Male | 271 Participants | 556 Participants | 315 Participants | 609 Participants | 1751 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 732 | 0 / 1,686 | 0 / 852 | 0 / 1,847 |
| serious Total, serious adverse events | 0 / 732 | 0 / 1,686 | 0 / 852 | 0 / 1,847 |
Outcome results
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.
Time frame: 16 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Low Risk Experimental Group | Percentage of Participants With Tooth Loss Over 16 Year Period | 16.4 percentage of participants |
| Low Risk Control Group | Percentage of Participants With Tooth Loss Over 16 Year Period | 13.8 percentage of participants |
| High Risk Experimental Group | Percentage of Participants With Tooth Loss Over 16 Year Period | 22.1 percentage of participants |
| High Risk Control Group | Percentage of Participants With Tooth Loss Over 16 Year Period | 16.9 percentage of participants |
Secondary
Change in Evaluation for Dental Caries and Oral Cancer Within the Risk Categories
Time frame: 10 and 15 years
Secondary
Change in Periodontal Surgery Claims
Time frame: 10 and 15 years
Secondary
Change in Relationship of Risk Category & Tooth Loss Rate With Systemic Disease History on Questionnaire.
Time frame: 10 and 15 years
Secondary
Change in Total Dental Claims During Monitoring Period
Time frame: 10 and 15 years
Secondary
Change in Total Periodontal Claims During the Monitoring Period
Time frame: 10 and 15 years