Periodontal DiseasesNCT04268381
Oral and Systemic aMMP-8 in Periodontal Disease
An observational study of Periodontal Diseases and Periodontal Inflammation, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
Periodontal disease is an inflammatory process that can result in tooth loss and also is considered a modifying factor for systemic health. Matrix metalloproteinase (MMP)-8 is the major collagenase of periodontal tissue breakdown. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Periodontal Inflammation
- What is being tested?
- Biochemical analysis
- How many people
- 83 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2020to 20 Mar 2020
- 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 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy controls (n=23) includes volunteers with clinically healthy periodontium who had BOP < 10% and PD ≤ 3 mm, no sites with > 1 mm attachment loss, no radiographic sign of alveolar bone destruction and no history of periodontitis. Gingivitis patients (n=20) shows PD ≤ 3 mm with BOP > 50% in the entire mouth as well as no clinical attachment loss or alveolar bone loss. Periodontitis patients (Generalized Stage 3) have interdental CAL ≥ 5 mm at least 2 non-adjacent teeth, PD ≥ 6 mm and radiographic bone loss affecting 30% of the teeth or more.They show also no more than 4 teeth loss due to periodontitis.
Who may be able to join
- systemically healthy and non-smoker individuals aged 25 to 50 years
- having ≥20 teeth present (except third molars)
- individuals with periodontally healthy, gingivitis and stage 3 periodontitis diagnoses
Who cannot join
- having any systemic disease
- smoking
- pregnancy or lactation
- using antibiotic or any anti-inflammatory drug or any periodontal treatment within the past 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Local And Systemic Levels of aMMP-8 in Gingivitis and Stage 3 Periodontitis
Periodontal disease is an inflammatory process that can result in tooth loss and also is considered a modifying factor for systemic health. Matrix metalloproteinase (MMP)-8 is the major collagenase of periodontal tissue breakdown. The aim of the present study is to analyze active (aMMP-8) levels in gingival crevicular fluid (GCF), saliva and serum in the context of new criteria of gingivitis and stage 3 grade C periodontitis.
- Conditions
- Periodontal Diseases, Periodontal Inflammation
- Being tested
- Biochemical analysis
- Keywords
- periodontitis, gingivitis, matrix metalloproteinases
- Medical subject headings
- Periodontal Diseases, Periodontitis, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biochemical analysisOther
aMMP-8 is measured by immunofluorometric assay (IFMA).
| Study group | Role | What they receive |
|---|---|---|
| Healthy (n=23) | Not described Receives: Other: Biochemical analysis | |
| Gingivitis (n=20) | Not described Receives: Other: Biochemical analysis | |
| Periodontitis (n=40) | Not described Receives: Other: Biochemical analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral (GCF and saliva) and serum levels of aMMP-8 in periodontitis and gingivitis
aMMP-8 levels
Measured: through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start20 Jan 2020
- Primary completion20 Mar 2020
- Study completion20 Mar 2020
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 Aydin Adnan Menderes UniversityThe 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Collaborators
- Giresun University
- Responsible party
- Principal investigator, Zeynep Pinar KELES YUCEL, Giresun University
- Investigators
- Zeynep Pinar Keles Yucel, Principal investigator, Department of Periodontology, School of Dentistry, Giresun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04268381
- Sponsor's protocol ID
- 20-2T/39
- Status last verified
- Jul 2020
- First submitted
- 10 Feb 2020
- Last updated
- 14 Jul 2020
- Results posted
- 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 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local And Systemic Levels of aMMP-8 in Gingivitis and Stage 3 Periodontitis
- ClinicalTrials.gov ID
- NCT04268381
- Acronym / sponsor ID
- 20-2T/39
- Conditions
- Periodontal Diseases, Periodontal Inflammation
- Keywords
- periodontitis, gingivitis, matrix metalloproteinases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Collaborators
- Giresun University
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 13 Feb 2020 (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.
Periodontal disease is an inflammatory process that can result in tooth loss and also is considered a modifying factor for systemic health. Matrix metalloproteinase (MMP)-8 is the major collagenase of periodontal tissue breakdown. The aim of the present study is to analyze active (aMMP-8) levels in gingival crevicular fluid (GCF), saliva and serum in the context of new criteria of gingivitis and stage 3 grade C periodontitis.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy (n=23) | – | Other: Biochemical analysis |
| Gingivitis (n=20) | – | Other: Biochemical analysis |
| Periodontitis (n=40) | – | Other: Biochemical analysis |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy controls (n=23) includes volunteers with clinically healthy periodontium who had BOP < 10% and PD ≤ 3 mm, no sites with > 1 mm attachment loss, no radiographic sign of alveolar bone destruction and no history of periodontitis. Gingivitis patients (n=20) shows PD ≤ 3 mm with BOP > 50% in the entire mouth as well as no clinical attachment loss or alveolar bone loss. Periodontitis patients (Generalized Stage 3) have interdental CAL ≥ 5 mm at least 2 non-adjacent teeth, PD ≥ 6 mm and radiographic bone loss affecting 30% of the teeth or more.They show also no more than 4 teeth loss due to periodontitis.
Key inclusion criteria (3 listed)
- systemically healthy and non-smoker individuals aged 25 to 50 years
- having ≥20 teeth present (except third molars)
- individuals with periodontally healthy, gingivitis and stage 3 periodontitis diagnoses
Key exclusion criteria (4 listed)
- having any systemic disease
- smoking
- pregnancy or lactation
- using antibiotic or any anti-inflammatory drug or any periodontal treatment within the past 6 months.
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 |
|---|---|---|
| Biochemical analysisaMMP-8 is measured by immunofluorometric assay (IFMA). | Other | Gingivitis (n=20), Healthy (n=23), Periodontitis (n=40) |
Primary outcome
Oral (GCF and saliva) and serum levels of aMMP-8 in periodontitis and gingivitis
Time frame: through study completion, an average of 4 months
aMMP-8 levels
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 14 Jul 2020.
- 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.
Zeynep Pinar Keles Yucel principal investigator
Department of Periodontology, School of Dentistry, Giresun University
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 Periodontal Diseases and Periodontal Inflammation, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 14 Jul 2020. 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 Turkey (Türkiye). 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 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?
Oral (GCF and saliva) and serum levels of aMMP-8 in periodontitis and gingivitis (time frame: through study completion, an average of 4 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 14 Jul 2020.