Periodontal DiseasesNCT05153798
Evaluation of PerioMonitor for Detection of Oral Inflammatory Load (OIL) in Human Subjects
An observational study of Periodontal Diseases, run by Oral Science International Inc. at 3 sites in 2 countries.
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 presumptive detection of oral inflammation associated with periodontal diseases. PerioMonitor is an IVD device for the rapid, semi-quantitative detection of PMN in oral samples. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontal Diseases
- Type of treatment
- Pill or oral medicine
- How many people
- 117 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 29 Nov 2021to 31 Jan 2022
- 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: Subjects will be selected amongst patients visiting the Sites for their scheduled regular exams, which are all outpatient dental clinics
Who may be able to join
- subject > 18 years old;
- subject fluent in English; and
- subject has signed an ICF.
Who cannot join
- Subject with altered mental status/inability to provide informed consent or follow the procedure of the Study; and
- Previous enrolment into the current Study.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Robert A. Lowe Dental Office
Charlotte, North Carolina, 28226
Robert A Lowe, D.D.S, 704-450-3321, boblowedds@aol.com
Fort Lee Dental Office
Fort Lee, New Jersey, 07024
Howard S Glazer, D.D.S., 201-224-2705, hglazer264@gmail.com
Canada1 site
OMG Perio
Hamilton, Ontario, L8N 1K4
Alon Borenstein, D.M.D, (289) 639-2732, dr.alon.borenstein@gmail.com
Kristina Kovacs, (289) 639-2732, reception@omgperio.ca
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 presumptive detection of oral inflammation associated with periodontal diseases.
PerioMonitor is an IVD device for the rapid, semi-quantitative detection of PMN in oral samples. This test is intended for prescription use at Point-of-Care ("POC") settings by health care professionals.
Read the detailed description
PerioMonitor is an IVD device for the rapid, semi-quantitative detection of PMN in oral samples. This test is intended for prescription use at POC settings by health care professionals. This type of In vitro diagnostic device (IVDD) is also sometimes defined as a "Near-Patient Testing" IVDD.
Conducting investigational testing is a pre-requisite to obtain a Class III medical device licence in respect to in vitro diagnostic devices intended for use in POC settings (e.g., home use or outpatient dental clinic) from Health Canada. Such studies are mandatory to establish the safety and effectiveness of the device should be presented to support the performance for each claimed indication for use. They must be conducted on the device using human subjects representative of the intended users and under conditions similar to the conditions of use, to provide reasonable assurance of safety and effectiveness for the intended use. This notably includes:
- studies to evaluate the sensitivity and the specificity of the device to provide clinically meaningful results in the target population; and
- consumer fields evaluations, i.e., studies evaluating the performance of the device when used by the intended users without assistance, following instructions provided in the labelling.
The same is also applicable in the United States of America. More specifically with respect to consumer field evaluations, FDA requires clinical data to determine whether particular tests are "simple" and have "an insignificant risk of an erroneous result" to be approved for waiver under the CLIA criteria and cleared for use in POC settings.
This document is a clinical investigational plan specifically designed for the conduct of a blinded, multicenter and prospective, single arm human Study to evaluate the safety and the efficacy of PerioMonitor as an aid to the presumptive detection of oral inflammation associated with periodontal diseases.
This single-arm Study is designed to be representative of the intended use of PerioMonitor as well as the intended users, intended patient population and intended environment of use. To this end, the Study will include a minimum of 117 subjects, tested by HCPs working in three different dental clinics (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, with PerioMonitor.
- Conditions
- Periodontal Diseases
- Keywords
- Periodontal, Inflammation, Gingivits, PerioMonitor, Bleeding on Probing, Periodontitis
- Medical subject headings
- Periodontal Diseases, Inflammation, Periodontitis
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 | 117 Subject to be tested for Oral Inflammatory Load (OIL) with PerioMonitor. Same subjects to be tested for Oral Inflammation with the BOP method. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of PerioMonitor
The primary objective of this blinded, multicenter and prospective Study is to evaluate the sensitivity and the specificity of PerioMonitor for semi-quantitative detection of PMN in human oral specimens, which may improve the detection of oral inflammation associated with periodontal diseases. Based on our preliminary results, a sensitivity of 90% (95CI 80.0-100%) and a specificity of 75% (65.1-100%) are expected when testing a cohort of 117 subjects.
Measured: 6 months
Secondary outcomes (1)
Usability of PerioMonitor in Point-of-Care (POC) settings
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 HCPs 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, with a negligible likelihood of erroneous results.
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 posted10 Dec 2021
- Study start29 Nov 2021 (estimated)
- Primary completion31 Jan 2022 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oral Science International Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- JSS Medical Research Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05153798
- Sponsor's protocol ID
- Pro00055087
- Status last verified
- Nov 2021
- First submitted
- 8 Dec 2021
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. 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
- NCT05153798
- Acronym / sponsor ID
- Pro00055087
- Conditions
- Periodontal Diseases
- Keywords
- Periodontal, Inflammation, Gingivits, PerioMonitor, Bleeding on Probing, Periodontitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- Oral Science International Inc.Industry (pharma, biotech, devices)
- Collaborators
- JSS Medical Research Inc.
- Study start
- 29 Nov 2021 (estimated)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 10 Dec 2021 (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 presumptive detection of oral inflammation associated with periodontal diseases.
PerioMonitor is an IVD device for the rapid, semi-quantitative detection of PMN in oral samples. This test is intended for prescription use at Point-of-Care ("POC") settings by health care professionals.
Detailed description
PerioMonitor is an IVD device for the rapid, semi-quantitative detection of PMN in oral samples. This test is intended for prescription use at POC settings by health care professionals. This type of In vitro diagnostic device (IVDD) is also sometimes defined as a "Near-Patient Testing" IVDD.
Conducting investigational testing is a pre-requisite to obtain a Class III medical device licence in respect to in vitro diagnostic devices intended for use in POC settings (e.g., home use or outpatient dental clinic) from Health Canada. Such studies are mandatory to establish the safety and effectiveness of the device should be presented to support the performance for each claimed indication for use. They must be conducted on the device using human subjects representative of the intended users and under conditions similar to the conditions of use, to provide reasonable assurance of safety and effectiveness for the intended use. This notably includes:
- studies to evaluate the sensitivity and the specificity of the device to provide clinically meaningful results in the target population; and
- consumer fields evaluations, i.e., studies evaluating the performance of the device when used by the intended users without assistance, following instructions provided in the labelling.
The same is also applicable in the United States of America. More specifically with respect to consumer field evaluations, FDA requires clinical data to determine whether particular tests are "simple" and have "an insignificant risk of an erroneous result" to be approved for waiver under the CLIA criteria and cleared for use in POC settings.
This document is a clinical investigational plan specifically designed for the conduct of a blinded, multicenter and prospective, single arm human Study to evaluate the safety and the efficacy of PerioMonitor as an aid to the presumptive detection of oral inflammation associated with periodontal diseases.
This single-arm Study is designed to be representative of the intended use of PerioMonitor as well as the intended users, intended patient population and intended environment of use. To this end, the Study will include a minimum of 117 subjects, tested by HCPs working in three different dental clinics (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, with PerioMonitor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PerioMonitor Testing | – | –117 Subject to be tested for Oral Inflammatory Load (OIL) with PerioMonitor. Same subjects to be tested for Oral Inflammation with the BOP method. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects will be selected amongst patients visiting the Sites for their scheduled regular exams, which are all outpatient dental clinics
Key inclusion criteria (3 listed)
- subject > 18 years old;
- subject fluent in English; and
- subject has signed an ICF.
Key exclusion criteria (2 listed)
- Subject with altered mental status/inability to provide informed consent or follow the procedure of the Study; and
- 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
Sensitivity and specificity of PerioMonitor
Time frame: 6 months
The primary objective of this blinded, multicenter and prospective Study is to evaluate the sensitivity and the specificity of PerioMonitor for semi-quantitative detection of PMN in human oral specimens, which may improve the detection of oral inflammation associated with periodontal diseases. Based on our preliminary results, a sensitivity of 90% (95CI 80.0-100%) and a specificity of 75% (65.1-100%) are expected when testing a cohort of 117 subjects.
1 secondary outcome
Usability of PerioMonitor in Point-of-Care (POC) settings
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
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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.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Diseases, run by Oral Science International Inc. at 3 sites in 2 countries.
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 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: status not confirmed, as of the sponsor's last update on 10 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alon Borenstein, D.M.D ((289) 639-2732, reception@omgperio.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of PerioMonitor (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 10 Dec 2021.