Dental Engagement Study Behavior Modification

PERIODONTAL DISEASE Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02749318
• Other study ID #: ILI-16-137-P-US
• Status: Withdrawn
• Phase: N/A
• First received: April 14, 2016
• Last updated: September 12, 2017
• Start date: July 2017
• Est. completion date: June 2018

Study information

• Verified date: September 2017
• Source: Interleukin Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Diseases
• PERIODONTAL DISEASE
• Periodontal Diseases

Intervention

Genetic:
• IL-1 genetic test for risk of severe periodontitis
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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Interleukin Genetics, Inc.	Duke University, Kaiser Permanente

References & Publications (2)

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. — View Citation

Wu X, Offenbacher S, L?pez 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Questionnaire on patient demographics and dental healthcare behavior	Reasons for not fully utilizing preventive oral health care insurance benefits	At enrollment by survey
Secondary	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