Dental Engagement Study Behavior Modification

Not Applicable

Withdrawn

• Conditions: PERIODONTAL DISEASE
• Interventions: Genetic: IL-1 genetic test for risk of severe periodontitis

• Registration Number: NCT02749318
• Lead Sponsor: Interleukin Genetics, Inc.

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.

Study Timeline

• Study First Submitted: 2016-04-14
• Study First Submitted QC: 2016-04-21
• Study First Posted: 2016-04-22
• Study Start: 2017-07
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-12
• Last Update Posted: 2017-09-13
• Primary Completion: 2018-06
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	IL-1 genetic test for risk of severe periodontitis	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.

Primary Outcome Measures

Name	Time	Method
The number of preventive oral health care visits per patient (Dental office visit record review)	18 months from enrollment	Frequency of preventive oral health care visits within 18 months of enrollment.

Secondary Outcome Measures

Name	Time	Method
Questionnaire on patient demographics and dental healthcare behavior	At enrollment by survey	Reasons for not fully utilizing preventive oral health care insurance benefits
Questionnaire on changes in oral health care behavior and attitudes on genetic testing	18 months after enrollment	Reasons for changes in frequency of preventive oral health care behaviors.