PERIODONTAL DISEASENCT02749318
Dental Engagement Study Behavior Modification
A study testing IL-1 genetic test for risk of severe periodontitis in people with PERIODONTAL DISEASE, run by Interleukin Genetics, Inc..
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PERIODONTAL DISEASE
- What is being tested?
- IL-1 genetic test for risk of severe periodontitis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2017to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who previously have had an IL-1 dental genetic test.
- Patients who have been diagnosed with periodontal disease.
About this study
Official title: Engagement Study: (Multi-site, Practice-Based Research Network (PBRN) Prospective Clinical Trial to Assess if Knowledge of Genetic Risk Changes Behavior)
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.
Read the 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.
- Conditions
- PERIODONTAL DISEASE
- Being tested
- IL-1 genetic test for risk of severe periodontitis
- Keywords
- Behavior Modification, Genetic Testing, Risk Management, Oral Health Care
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IL-1 genetic test for risk of severe periodontitisGenetic
Also called PerioPredict® Genetic Risk Test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months from enrollment
Secondary outcomes (2)
Questionnaire on patient demographics and dental healthcare behavior
Reasons for not fully utilizing preventive oral health care insurance benefits
Measured: 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.
Measured: 18 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startJul 2017 (estimated)
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Why it stopped: Company Assets Being Sold
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PERIODONTAL DISEASEStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Interleukin Genetics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke University, Kaiser Permanente
- Responsible party
- Sponsor
- Investigators
- Kenneth S Kornman, D.D.S. PhD., Principal investigator, Interleukin Genetics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02749318
- Sponsor's protocol ID
- ILI-16-137-P-US
- Status last verified
- Sep 2017
- First submitted
- 14 Apr 2016
- Last updated
- 13 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24690098Giannobile 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.
PubMed 23752171
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engagement Study: (Multi-site, Practice-Based Research Network (PBRN) Prospective Clinical Trial to Assess if Knowledge of Genetic Risk Changes Behavior)
- ClinicalTrials.gov ID
- NCT02749318
- Acronym / sponsor ID
- ILI-16-137-P-US
- Conditions
- PERIODONTAL DISEASE
- Keywords
- Behavior Modification, Genetic Testing, Risk Management, Oral Health Care
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Company Assets Being Sold
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Interleukin Genetics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Duke University, Kaiser Permanente
- Study start
- Jul 2017 (estimated)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Genetic: IL-1 genetic test for risk of severe periodontitisConsented 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients who previously have had an IL-1 dental genetic test.
- Patients who have been diagnosed with periodontal disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IL-1 genetic test for risk of severe periodontitisAlso: PerioPredict® Genetic Risk TestDNA 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. | Genetic | Experimental Group |
Primary outcome
The number of preventive oral health care visits per patient (Dental office visit record review)
Time frame: 18 months from enrollment
Frequency of preventive oral health care visits within 18 months of enrollment.
2 secondary outcomes
Questionnaire on patient demographics and dental healthcare behavior
Time frame: At enrollment by survey
Questionnaire on changes in oral health care behavior and attitudes on genetic testing
Time frame: 18 months after enrollment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2017.
- Background: PubMed 24690098Wu 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.
- Background: PubMed 23752171Giannobile 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth S Kornman, D.D.S. PhD. principal investigator
Interleukin Genetics, Inc.
Questions about this trial
What is this clinical trial studying?
A study testing IL-1 genetic test for risk of severe periodontitis in people with PERIODONTAL DISEASE, run by Interleukin Genetics, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of preventive oral health care visits per patient (Dental office visit record review) (time frame: 18 months from enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02749318, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2017.