GingivitisNCT02403297
Rapid Point-of-Care Salivary Diagnostic for Periodontal Health
An observational study of Gingivitis and Periodontal Disease, run by Innovative Diagnostics Inc at 1 site in United States.
Trial summary
The purpose of this study is to learn if a chair-side testing device will accurately measure levels of a salivary biomarker and thus indicate if a patient has periodontal health, gingivitis or periodontal disease. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Periodontal Disease
- What is being tested?
- Quik Check PD
- Type of treatment
- Medical device
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to May 2016
- Phase
- Observational
- 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 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Three groups of individuals will be recruited: those that are orally healthy and do not have any oral discomfort (N=58), those who have gingivitis (i.e., bleeding gums; N=58), and those who have periodontal disease (N=58). The groups will be matched by gender and smoking status. Women are predicted to account for 50% of the participants. The age distribution will be 18 to 95 years. Subjects will not be excluded based on race, gender, or ethnicity.
Who may be able to join
- Males or females of all racial and ethnic groups over 18 years of age;
- At least 20 erupted teeth and the ability to provide expectorated saliva;
- Able and willing to comply with study requirements; and
- Have full understanding of all elements of, and signature and dating of the written informed consent prior to the initiation of protocol specified procedures
Who cannot join
- Prisoners or institutionalized individuals;
- Persons with acute illness or infectious disease (as evidenced by fever, malaise, sore throat, recurrent cough, lymphadenopathy, swelling and/or a physician consultation);
- Evidence of oral mucosal lesion or ulceration; or
- Use of glucocorticoids or cyclooxygenase inhibitors (i.e. such as ibuprofen, Naprosyn(Aleve) or non-steroidal anti-inflammatory drug) daily for the past two weeks.
Trial locations and contacts
1 site in 1 country.
United States1 site
Innovative Diagnostics Inc
Lexington, Kentucky, 40506
About this study
The purpose of this study is to learn if a chair-side testing device will accurately measure levels of a salivary biomarker and thus indicate if a patient has periodontal health, gingivitis or periodontal disease.
Read the detailed description
Human subjects will participate in this cross-sectional study by attending a single visit where their mouth will be examined and saliva will be collected to help determine the accuracy of a POC salivary diagnostic device. The study population will consist of 174 persons (58 that are orally healthy and have no oral discomfort; 58 that have gingivitis; and 58 that have periodontitis. The device results (i.e., visual and optical scans) will be compared against the Luminex results by two methods: 1) the Bland-Altman procedure and 2) discriminant analysis that examines whether the concentration would correctly identify the subject as health or disease using a defined threshold for MMP-8 levels.
Three groups of individuals will be recruited: those that are orally healthy and do not have any oral discomfort (N=58), those who have gingivitis (i.e., bleeding gums; N=58), and those who have periodontal disease (N=58). The groups will be matched by gender and smoking status. Women are predicted to account for 50% of the participants. The age distribution will be 18 to 95 years. Subjects will not be excluded based on race, gender, or ethnicity.
- Conditions
- Gingivitis, Periodontal Disease
- Being tested
- Quik Check PD
- Keywords
- Bleeding gums, Gum inflammation, Saliva
- Medical subject headings
- Gingivitis, Periodontal Diseases, Gingival Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quik Check PDDevice
The device is not an intervention. It is a device to determine if MMP-8 is present in a subjects saliva.
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Saliva will be collected from 58 subjects determined to be "healthy" according to the protocol. Receives: Device: Quik Check PD | |
| Gingivitis | Saliva will be collected from 58 subjects determined to have gingivitis according to the protocol. Receives: Device: Quik Check PD | |
| Periodontal disease | Saliva will be collected from 58 subjects determined to have periodontal disease according to the protocol. Receives: Device: Quik Check PD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of MMP-8 in the subjects saliva using the Quik Check PD device
Measured: One day. Subjects complete the study in 45 minutes.
Secondary outcomes (1)
Amount of MMP-8 in the subjects saliva sample using Luminex Analysis
Measured: One day. Subjects complete the study in 45 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionNov 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovative Diagnostics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02403297
- Sponsor's protocol ID
- 2013-1R43DE024015-01
- Status last verified
- Aug 2016
- First submitted
- 23 Mar 2015
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Point-of-Care Salivary Diagnostic for Periodontal Health
- ClinicalTrials.gov ID
- NCT02403297
- Acronym / sponsor ID
- 2013-1R43DE024015-01
- Conditions
- Gingivitis, Periodontal Disease
- Keywords
- Bleeding gums, Gum inflammation, Saliva
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Innovative Diagnostics IncIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 31 Mar 2015 (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.
The purpose of this study is to learn if a chair-side testing device will accurately measure levels of a salivary biomarker and thus indicate if a patient has periodontal health, gingivitis or periodontal disease.
Detailed description
Human subjects will participate in this cross-sectional study by attending a single visit where their mouth will be examined and saliva will be collected to help determine the accuracy of a POC salivary diagnostic device. The study population will consist of 174 persons (58 that are orally healthy and have no oral discomfort; 58 that have gingivitis; and 58 that have periodontitis. The device results (i.e., visual and optical scans) will be compared against the Luminex results by two methods: 1) the Bland-Altman procedure and 2) discriminant analysis that examines whether the concentration would correctly identify the subject as health or disease using a defined threshold for MMP-8 levels.
Three groups of individuals will be recruited: those that are orally healthy and do not have any oral discomfort (N=58), those who have gingivitis (i.e., bleeding gums; N=58), and those who have periodontal disease (N=58). The groups will be matched by gender and smoking status. Women are predicted to account for 50% of the participants. The age distribution will be 18 to 95 years. Subjects will not be excluded based on race, gender, or ethnicity.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Device: Quik Check PDSaliva will be collected from 58 subjects determined to be "healthy" according to the protocol. |
| Gingivitis | – | Device: Quik Check PDSaliva will be collected from 58 subjects determined to have gingivitis according to the protocol. |
| Periodontal disease | – | Device: Quik Check PDSaliva will be collected from 58 subjects determined to have periodontal disease according to the protocol. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Three groups of individuals will be recruited: those that are orally healthy and do not have any oral discomfort (N=58), those who have gingivitis (i.e., bleeding gums; N=58), and those who have periodontal disease (N=58). The groups will be matched by gender and smoking status. Women are predicted to account for 50% of the participants. The age distribution will be 18 to 95 years. Subjects will not be excluded based on race, gender, or ethnicity.
Key inclusion criteria (4 listed)
- Males or females of all racial and ethnic groups over 18 years of age;
- At least 20 erupted teeth and the ability to provide expectorated saliva;
- Able and willing to comply with study requirements; and
- Have full understanding of all elements of, and signature and dating of the written informed consent prior to the initiation of protocol specified procedures
Key exclusion criteria (4 listed)
- Prisoners or institutionalized individuals;
- Persons with acute illness or infectious disease (as evidenced by fever, malaise, sore throat, recurrent cough, lymphadenopathy, swelling and/or a physician consultation);
- Evidence of oral mucosal lesion or ulceration; or
- Use of glucocorticoids or cyclooxygenase inhibitors (i.e. such as ibuprofen, Naprosyn(Aleve) or non-steroidal anti-inflammatory drug) daily for the past two weeks.
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 |
|---|---|---|
| Quik Check PDThe device is not an intervention. It is a device to determine if MMP-8 is present in a subjects saliva. | Device | Gingivitis, Healthy, Periodontal disease |
Primary outcome
Presence of MMP-8 in the subjects saliva using the Quik Check PD device
Time frame: One day. Subjects complete the study in 45 minutes.
1 secondary outcome
Amount of MMP-8 in the subjects saliva sample using Luminex Analysis
Time frame: One day. Subjects complete the study in 45 minutes.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gingivitis and Periodontal Disease, run by Innovative Diagnostics Inc at 1 site in United States.
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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 17 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 stopped early. Results are not available in the source record.
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?
Presence of MMP-8 in the subjects saliva using the Quik Check PD device (time frame: One day. Subjects complete the study in 45 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2016.