Oral InflammationNCT05886855
Evaluation of PerioMonitor for Detection of Oral Inflammatory Load (OIL) in Human Subjects.
An observational study of Oral Inflammation, run by Oral Science International Inc..
Trial summary
The purpose of this multicenter, prospective, single arm Study is to evaluate the efficacy and safety of PerioMonitor as an aid to the detection of oral inflammation associated with periodontal diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Inflammation
- Type of treatment
- Pill or oral medicine
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 24 May 2023to 31 Jan 2024
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Individuals visiting a dental clinic for a regular exam.
Who may be able to join
- subject > 18 years old;
- subject fluent in English; and
- subject has signed the ICF
Who cannot join
- Subject with altered mental status/inability to provide informed consent or follow the procedure of the Study; and
- Subject using immunosuppressants including biologics such as adalimumab (Humira) and infliximab (Remicade); or calcineurin inhibitors such as tacrolimus (Envarsus XR or Protopic) and cyclosporine (Gengraf, Neotal or Sandimmmune); or corticosteroids (Prednisone); or azathioprine (Imuran)
- Oral rinse specimens received 5 days or more after PerioMonitor testing by the clinical laboratory
- Previous enrolment into the current Study.
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this multicenter, prospective, single arm Study is to evaluate the efficacy and safety of PerioMonitor as an aid to the detection of oral inflammation associated with periodontal diseases.
PerioMonitor is an IVD device for the rapid, semi-quantitative detection of neutrophil enzyme activity in oral samples. This test is intended for prescription use at Point-of-Care ("POC") settings by health care professionals.
Read the detailed description
The purpose of this multicenter, prospective, single arm Study is to evaluate the efficacy and safety of PerioMonitor as an aid to the detection of oral inflammation associated with periodontal diseases.
PerioMonitor is an IVD device for the rapid, semi-quantitative detection of neutrophil enzyme activity in oral samples. This test is intended for prescription use at Point-of-Care ("POC") settings by health care professionals.
The primary objective of this Study is to evaluate the Positive Percent Agreement (PPA)PPA and the Negative Percent Agreement (NPA)NPA of PerioMonitor for semi-quantitative detection of neutrophil enzyme activity in human oral specimens, to detect oral inflammation associated with periodontal diseases (subjects having more than 50 000 neutrophils/mL in their oral specimen or having more than 10% of bleeding sites when tested with the BOP method).
The secondary objective is to validate the claim that PerioMonitor can be used in POC settings (i.e., representative of the intended users and under conditions similar to the conditions of use), at the time of the consultation, with instant availability of results, by healthcare professionals (HCP) working in a dental clinic (i.e. with the background, education, and training of those who will perform the test in its intended environment) that are not qualified laboratory technicians, to make immediate and informed decisions about patient care.
- Conditions
- Oral Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PerioMonitor Testing | 400 Subject to be tested for Oral Inflammatory Load (OIL) with PerioMonitor. Same subjects to be tested for Oral Inflammation with the BOP method and neutrophil count. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding on Probing (BOP)
Confirmation of oral inflammation if BOP is equal or above 10%
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start24 May 2023 (estimated)
- Primary completion20 Dec 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral InflammationStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oral Science International Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Advarra
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05886855
- Sponsor's protocol ID
- 230123-01
- Status last verified
- May 2023
- First submitted
- 23 May 2023
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of PerioMonitor for Detection of Oral Inflammatory Load (OIL) in Human Subjects.
- ClinicalTrials.gov ID
- NCT05886855
- Acronym / sponsor ID
- 230123-01
- Conditions
- Oral Inflammation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Oral Science International Inc.Industry (pharma, biotech, devices)
- Collaborators
- Advarra
- Study start
- 24 May 2023 (estimated)
- Primary completion
- 20 Dec 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 2 Jun 2023 (actual)
- 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 multicenter, prospective, single arm Study is to evaluate the efficacy and safety of PerioMonitor as an aid to the detection of oral inflammation associated with periodontal diseases.
PerioMonitor is an IVD device for the rapid, semi-quantitative detection of neutrophil enzyme activity in oral samples. This test is intended for prescription use at Point-of-Care ("POC") settings by health care professionals.
Detailed description
The purpose of this multicenter, prospective, single arm Study is to evaluate the efficacy and safety of PerioMonitor as an aid to the detection of oral inflammation associated with periodontal diseases.
PerioMonitor is an IVD device for the rapid, semi-quantitative detection of neutrophil enzyme activity in oral samples. This test is intended for prescription use at Point-of-Care ("POC") settings by health care professionals.
The primary objective of this Study is to evaluate the Positive Percent Agreement (PPA)PPA and the Negative Percent Agreement (NPA)NPA of PerioMonitor for semi-quantitative detection of neutrophil enzyme activity in human oral specimens, to detect oral inflammation associated with periodontal diseases (subjects having more than 50 000 neutrophils/mL in their oral specimen or having more than 10% of bleeding sites when tested with the BOP method).
The secondary objective is to validate the claim that PerioMonitor can be used in POC settings (i.e., representative of the intended users and under conditions similar to the conditions of use), at the time of the consultation, with instant availability of results, by healthcare professionals (HCP) working in a dental clinic (i.e. with the background, education, and training of those who will perform the test in its intended environment) that are not qualified laboratory technicians, to make immediate and informed decisions about patient care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PerioMonitor Testing | – | –400 Subject to be tested for Oral Inflammatory Load (OIL) with PerioMonitor. Same subjects to be tested for Oral Inflammation with the BOP method and neutrophil count. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Individuals visiting a dental clinic for a regular exam.
Key inclusion criteria (3 listed)
- subject > 18 years old;
- subject fluent in English; and
- subject has signed the ICF
Key exclusion criteria (4 listed)
- Subject with altered mental status/inability to provide informed consent or follow the procedure of the Study; and
- Subject using immunosuppressants including biologics such as adalimumab (Humira) and infliximab (Remicade); or calcineurin inhibitors such as tacrolimus (Envarsus XR or Protopic) and cyclosporine (Gengraf, Neotal or Sandimmmune); or corticosteroids (Prednisone); or azathioprine (Imuran)
- Oral rinse specimens received 5 days or more after PerioMonitor testing by the clinical laboratory
- Previous enrolment into the current Study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bleeding on Probing (BOP)
Time frame: 6 months
Confirmation of oral inflammation if BOP is equal or above 10%
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Inflammation, run by Oral Science International 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 3 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: status not confirmed, as of the sponsor's last update on 2 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michel Houde, Ph.D. (4507811578 ext. 240, houde.michel@lok-northamerica.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding on Probing (BOP) (time frame: 6 months). 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 2 Jun 2023.