Periodontal DiseasesNCT06784362
Diagnostic and Prognostic Test for Periodontitis and Peri-implantitis (AHC-FRDgrant)
An observational study of Periodontal Diseases and Periodontitis, run by University of Minnesota.
Trial summary
The dental community, dental insurance companies and the public are becoming increasingly aware of the high prevalence of gum disease around teeth (periodontitis) and around dental implants (peri-implantitis). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Periodontitis, Peri-Implantitis
- How many people
- 230 participants
- Where
- No sites listed yet
- Study dates
- 5 Dec 2016to 29 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with disease (cases) were diagnosed with generalized chronic severe periodontitis with at least five teeth having clinical evidence of disease [clinical attachment loss (CAL) ≥ 5mm and at least one site with probing depth (PD) ≥ 7 mm], and radiographic evidence of at least 30% bone loss. Control subjects exhibited a healthy periodontium (no PD \>3 mm. no site with CAL) with no radiographic evidence of bone loss. Case and control subjects were in good general health. Smoking habits were noted. Case and control exclusion criteria included: 1) uncontrolled systemic disease, such as diabetes; 2) systemic antibiotic use within the past 3 months; 3) unable to provide consent; and 4) history of periodontal treatment or local antibiotic use in the past 12 months; 5) use of NSAIDs in the past 3 weeks.
Who may be able to join
- Subjects with disease (cases) were diagnosed with generalized chronic severe periodontitis with at least five teeth having clinical evidence of disease [clinical attachment loss (CAL) ≥ 5mm, at least one site with probing depth (PD) ≥ 7 mm] and radiographic evidence of at least 30% bone loss
- Control subjects exhibited a healthy periodontium (no PD >3 mm. no site with CAL) with no radiographic evidence of bone loss.
- Case and control subjects were in good general health.
Who cannot join
- uncontrolled systemic disease, such as diabetes;
- systemic antibiotic use within the past 3 months;
- unable to provide consent; and
- history of periodontal treatment or local antibiotic use in the past 12 months;
- use of NSAIDs in the past 3 weeks.
About this study
The dental community, dental insurance companies and the public are becoming increasingly aware of the high prevalence of gum disease around teeth (periodontitis) and around dental implants (peri-implantitis). To date, it cannot be accurately predicted which individuals will develop or re-develop periodontitis or peri-implantitis, leading most dental patients to undergo unnecessary treatment and undue risks and costs. Gingival fluid is a serum-like fluid that diffuses into the oral cavity by flowing between the gum and the tooth or dental implant.
Oral bacteria that grow around teeth and dental implants induce inflammation and change the amount and composition of the gingival fluid. The study hypothesizes that the spectra of metabolites in the inflammatory transudates and exudates around teeth and dental-implants are predictors of future periodontitis or peri-implantitis. The first objective is to use proton nuclear magnetic resonance (H-NMR) spectroscopy in a cross-sectional study to map mapping the metabolites in the gingival fluid that are capable of discriminating between healthy gum tissue and gum tissue that shows signs of periodontitis or dental peri-implantitis. The second objective is to begin prospective measurement of gingival fluid metabolites every 6 months in (i) individuals without periodontitis or peri-implantitis (healthy group), (ii) individuals with periodontitis or peri- implantitis who have been informed of the need for treatment - but have decided not to have treatment (untreated group) and (iii) individuals who received treatment for periodontitis or peri-implantitis and are now receiving regular dental hygiene care every 3 months (high risk group). By defining metabolites that can discriminate health from disease (Aim 1) and by measuring proportional changes of key metabolites relative to disease progression over time (Aim 2), the study will be able to predict in a site-specific manner, (a) the risk of disease initiation in people who do not initially have periodontitis or peri-implantitis (healthy persons), and (b) disease progression in untreated people or in people who were treated and are currently in a dental hygiene maintenance program. Accomplishing these two aims will provide a foundation from which to increase the efficacy of prevention whilst abating the morbidity and cost associated with current clinical practice.
- Conditions
- Periodontal Diseases, Periodontitis, Peri-Implantitis
- Being tested
- No intervention
- Medical subject headings
- Periodontal Diseases, Periodontitis, Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is an observational study
| Study group | Role | What they receive |
|---|---|---|
| Healthy group | individuals without periodontitis or peri-implantitis Receives: Other: No intervention | |
| untreated group | individuals with periodontitis or peri- implantitis who have been informed of the need for treatment - but have decided not to have treatment (untreated group) Receives: Other: No intervention | |
| high risk group | individuals who received treatment for periodontitis or peri-implantitis and are now receiving regular dental hygiene care every 3 months (high risk group). Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
defining metabolites that can discriminate health from disease
Gingival fluid samples using use proton nuclear magnetic resonance (H-NMR) spectroscopy, every 6 months for 24 months
Measured: 6, 12, 18, 24 months
measuring proportional changes of key metabolites relative to disease progression over time
Gingival fluid samples using use proton nuclear magnetic resonance (H-NMR) spectroscopy, every 6 months for 24 months
Measured: 6, 12, 18, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start5 Dec 2016
- Primary completion29 Jan 2024
- Study completion29 Jan 2024
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.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06784362
- Sponsor's protocol ID
- #1511M79922
- Status last verified
- Jan 2025
- First submitted
- 14 Jan 2025
- Last updated
- 20 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Prognostic Test for Periodontitis and Peri-implantitis (AHC-FRDgrant)
- ClinicalTrials.gov ID
- NCT06784362
- Acronym / sponsor ID
- #1511M79922
- Conditions
- Periodontal Diseases, Periodontitis, Peri-Implantitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 5 Dec 2016 (actual)
- Primary completion
- 29 Jan 2024 (actual)
- Study completion
- 29 Jan 2024 (actual)
- First posted
- 20 Jan 2025 (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 dental community, dental insurance companies and the public are becoming increasingly aware of the high prevalence of gum disease around teeth (periodontitis) and around dental implants (peri-implantitis). To date, it cannot be accurately predicted which individuals will develop or re-develop periodontitis or peri-implantitis, leading most dental patients to undergo unnecessary treatment and undue risks and costs. Gingival fluid is a serum-like fluid that diffuses into the oral cavity by flowing between the gum and the tooth or dental implant.
Oral bacteria that grow around teeth and dental implants induce inflammation and change the amount and composition of the gingival fluid. The study hypothesizes that the spectra of metabolites in the inflammatory transudates and exudates around teeth and dental-implants are predictors of future periodontitis or peri-implantitis. The first objective is to use proton nuclear magnetic resonance (H-NMR) spectroscopy in a cross-sectional study to map mapping the metabolites in the gingival fluid that are capable of discriminating between healthy gum tissue and gum tissue that shows signs of periodontitis or dental peri-implantitis. The second objective is to begin prospective measurement of gingival fluid metabolites every 6 months in (i) individuals without periodontitis or peri-implantitis (healthy group), (ii) individuals with periodontitis or peri- implantitis who have been informed of the need for treatment - but have decided not to have treatment (untreated group) and (iii) individuals who received treatment for periodontitis or peri-implantitis and are now receiving regular dental hygiene care every 3 months (high risk group). By defining metabolites that can discriminate health from disease (Aim 1) and by measuring proportional changes of key metabolites relative to disease progression over time (Aim 2), the study will be able to predict in a site-specific manner, (a) the risk of disease initiation in people who do not initially have periodontitis or peri-implantitis (healthy persons), and (b) disease progression in untreated people or in people who were treated and are currently in a dental hygiene maintenance program. Accomplishing these two aims will provide a foundation from which to increase the efficacy of prevention whilst abating the morbidity and cost associated with current clinical practice.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy group | – | Other: No interventionindividuals without periodontitis or peri-implantitis |
| untreated group | – | Other: No interventionindividuals with periodontitis or peri- implantitis who have been informed of the need for treatment - but have decided not to have treatment (untreated group) |
| high risk group | – | Other: No interventionindividuals who received treatment for periodontitis or peri-implantitis and are now receiving regular dental hygiene care every 3 months (high risk group). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with disease (cases) were diagnosed with generalized chronic severe periodontitis with at least five teeth having clinical evidence of disease [clinical attachment loss (CAL) ≥ 5mm and at least one site with probing depth (PD) ≥ 7 mm], and radiographic evidence of at least 30% bone loss. Control subjects exhibited a healthy periodontium (no PD \>3 mm. no site with CAL) with no radiographic evidence of bone loss. Case and control subjects were in good general health. Smoking habits were noted. Case and control exclusion criteria included: 1) uncontrolled systemic disease, such as diabetes; 2) systemic antibiotic use within the past 3 months; 3) unable to provide consent; and 4) history of periodontal treatment or local antibiotic use in the past 12 months; 5) use of NSAIDs in the past 3 weeks.
Key inclusion criteria (3 listed)
- Subjects with disease (cases) were diagnosed with generalized chronic severe periodontitis with at least five teeth having clinical evidence of disease [clinical attachment loss (CAL) ≥ 5mm, at least one site with probing depth (PD) ≥ 7 mm] and radiographic evidence of at least 30% bone loss
- Control subjects exhibited a healthy periodontium (no PD >3 mm. no site with CAL) with no radiographic evidence of bone loss.
- Case and control subjects were in good general health.
Key exclusion criteria (5 listed)
- uncontrolled systemic disease, such as diabetes;
- systemic antibiotic use within the past 3 months;
- unable to provide consent; and
- history of periodontal treatment or local antibiotic use in the past 12 months;
- use of NSAIDs in the past 3 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 |
|---|---|---|
| No interventionThis is an observational study | Other | Healthy group, high risk group, untreated group |
Primary outcome
defining metabolites that can discriminate health from disease
Time frame: 6, 12, 18, 24 months
Gingival fluid samples using use proton nuclear magnetic resonance (H-NMR) spectroscopy, every 6 months for 24 months
measuring proportional changes of key metabolites relative to disease progression over time
Time frame: 6, 12, 18, 24 months
Gingival fluid samples using use proton nuclear magnetic resonance (H-NMR) spectroscopy, every 6 months for 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Diseases and Periodontitis, run by University of Minnesota.
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 5 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: finished, as of the sponsor's last update on 20 Jan 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
defining metabolites that can discriminate health from disease (time frame: 6, 12, 18, 24 months). The study lists 2 primary outcomes in all. 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 20 Jan 2025.