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Company Assets Being Sold
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| Name | Class |
|---|---|
| Duke University | OTHER |
| Kaiser Permanente | OTHER |
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This is a pilot study to determine whether knowledge gained by an individual of genetic risk for severe periodontitis changes the patient's health behavior as measured by an increased frequency of their preventive dental office visits. In addition to the primary objectives of the study, the overall design and logistics will be used to inform a possible future study.
Data to be analyzed in this study will be gathered through a patient questionnaire, genetic testing and tracking of preventive dental office visits. Eight hundred (800) total participants will be randomly assigned to either the Usual Care or Experimental Groups. Two hundred participants will be assigned to the Usual Care Group and 600 will be assigned to the Experimental Group. It is anticipated that approximately 17% (~100) of the Experimental Group subjects will refuse to enroll in the study, leaving a final total of approximately 500 subject in this group. Within the Experimental Group, 125 subjects positive for the IL-1 genetic test (PerioPredict® Genetic Risk Test, Interleukin Genetics, Inc., Waltham, MA) will be identified and ~375 will test negative for the IL-1 genetic test.
The Sponsor will enter the subject's dental office registration number into a master spreadsheet and randomly assign every fourth patient to the Usual Care Group and all others will be assigned into the Experimental Group. Information about the study and informed consent will be made available by the dental office for the specific groups, either by directing to a website location with videos and ICFs, or alternatively by by dental office showing informational videos on provided tablet and gathering signed hardcopy ICFs at schedule first visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Consented patients who complete the initial Experimental Group Questionnaire, receive a prophylaxis, have the IL-1 genetic test for risk of severe periodontitis performed, their dental records monitored for 18 months post-enrollment, and answer a Study Completion Questionnaire 18 months post-enrollment. |
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| Usual Care Group | No Intervention | Consented patients who complete the initial Usual Care Group Questionnaire, receive a prophylaxis and have their dental records monitored for 18 months post-enrollment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IL-1 genetic test for risk of severe periodontitis | Genetic | DNA obtained by cheek swab analyzed for four variations (SNPs) in the IL-1beta gene to determine whether patient is at elevated risk for more severe periodontal disease. |
| Measure | Description | Time Frame |
|---|---|---|
| The number of preventive oral health care visits per patient (Dental office visit record review) | Frequency of preventive oral health care visits within 18 months of enrollment. | 18 months from enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Questionnaire on patient demographics and dental healthcare behavior | Reasons for not fully utilizing preventive oral health care insurance benefits | At enrollment by survey |
| Questionnaire on changes in oral health care behavior and attitudes on genetic testing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth S Kornman, D.D.S. PhD. | Interleukin Genetics, Inc. | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24690098 | Background | Wu X, Offenbacher S, Lomicronpez NJ, Chen D, Wang HY, Rogus J, Zhou J, Beck J, Jiang S, Bao X, Wilkins L, Doucette-Stamm L, Kornman K. Association of interleukin-1 gene variations with moderate to severe chronic periodontitis in multiple ethnicities. J Periodontal Res. 2015 Feb;50(1):52-61. doi: 10.1111/jre.12181. Epub 2014 Apr 2. | |
| 23752171 |
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| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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Reasons for changes in frequency of preventive oral health care behaviors. |
| 18 months after enrollment |
| 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. |