Dental Engagement Study Behavior Modification

NCT02749318 | Withdrawn DMC

• 1 other identifier: ILI-16-137-P-US
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

PERIODONTAL DISEASE

Keywords

Behavior Modification; Genetic Testing; Risk Management; Oral Health Care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Questionnaire on patient demographics and dental healthcare behavior

  At enrollment by survey

• Questionnaire on changes in oral health care behavior and attitudes on genetic testing

  18 months after enrollment

Study Arms (2)

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.

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

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.

Interventions

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.

Also known as: PerioPredict® Genetic Risk Test

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients who previously have had an IL-1 dental genetic test.
• Patients who have been diagnosed with periodontal disease.

Sponsors & Collaborators

• Interleukin Genetics, Inc.: lead
• Duke University: collaborator
• Kaiser Permanente: collaborator

Related Publications (2)

• 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.

  PMID: 24690098 BACKGROUND

• 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.

  PMID: 23752171 BACKGROUND

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Kenneth S Kornman, D.D.S. PhD.

  Interleukin Genetics, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2016
• First Posted: April 22, 2016
• Study Start: July 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: September 13, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share