Dental Engagement Study Behavior Modification

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Engagement Study: (Multi-site, Practice-Based Research Network (PBRN) Prospective Clinical Trial to Assess if Knowledge of Genetic Risk Changes Behavior)

Conditions
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PERIODONTAL DISEASE

Intervention / Treatment
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* Genetic: IL-1 genetic test for risk of severe periodontitis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All adult (18 years of age or older) patients from multi-site, practice-based research network dental offices who have dental insurance coverage for preventive care twice per year, but have only used the benefit once per year in the past 2-3 years. Exclusion Criteria: Patients who previously have had an IL-1 dental genetic test. Patients who have been diagnosed with periodontal disease.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>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. | Genetic: IL-1 genetic test for risk of severe periodontitis<br>* 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.<br>* Other names: PerioPredict® Genetic Risk Test;|
| No Intervention: Usual Care Group<br>Consented patients who complete the initial Usual Care Group Questionnaire, receive a prophylaxis and have their dental records monitored for 18 months post-enrollment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Reasons for changes in frequency of preventive oral health care behaviors. | 18 months after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behavior Modification, Genetic Testing, Risk Management, Oral Health Care