Clinical trial NCT02749318: Dental Engagement Study Behavior Modification
Official title: Engagement Study: (Multi-site, Practice-Based Research Network (PBRN) Prospective Clinical Trial to Assess if Knowledge of Genetic Risk Changes Behavior)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: PERIODONTAL DISEASE
Keywords: Behavior Modification
Genetic Testing
Risk Management
Oral Health Care
Lead sponsor: Interleukin Genetics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Duke University
name: Kaiser Permanente
First posted: 2016-04-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The number of preventive oral health care visits per patient (Dental office visit record review)
timeFrame: 18 months from enrollment
Secondary outcomes:
measure: Questionnaire on patient demographics and dental healthcare behavior
timeFrame: At enrollment by survey
measure: Questionnaire on changes in oral health care behavior and attitudes on genetic testing
timeFrame: 18 months after enrollment
Other outcomes:
Locations:
Study officials:
affiliation: Interleukin Genetics, Inc.
name: Kenneth S Kornman, D.D.S. PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.