Periodontal DiseasesNCT03527901
Active Matrix Metalloproteinase-8 (aMMP-8) Chair-side Test in Different Periodontal Disease
An observational study of Periodontal Diseases, run by Aydin Adnan Menderes University.
Trial summary
The aim of this study to evaluate the diagnostic accuracy of a new qualitative aMMP-8 POC test in different periodontal health and disease and as compared to the established quantitative laboratory method (ELISA) Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- GCF collection with aMMP-8 chair side test and Saliva collection
- How many people
- 103 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2015to 1 Jun 2016
- How long will I take part?
- 12 Months
- 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 20 to 60 years
- All sexes
- Adult
Study population: All participants have minimum 20 teeth
Who may be able to join
- Systemically healthy
- Nonsmokers
Who cannot join
- Participants were not included if they had systemic disease such as diabetes, cardiovascular.
- Participants who took regular medications that could affect of periodontal tissue
- Participants who received antibiotics less than 10 weeks before the study
About this study
Official title: Evaluation of Active Matrix Metalloproteinase-8 (aMMP-8) Chair-side Test in Different Periodontal Disease and Healthy Implants
The aim of this study to evaluate the diagnostic accuracy of a new qualitative aMMP-8 POC test in different periodontal health and disease and as compared to the established quantitative laboratory method (ELISA)
Read the detailed description
MMP-8 has been reported to reflect the inflammatory status in periodontal tissues and, therefore represent as potential biomarkers of periodontitis. A positive aMMP-8 test could be an early indicator of these excessive and undesired tissue reactions.
- Conditions
- Periodontal Diseases
- Being tested
- GCF collection with aMMP-8 chair side test, Saliva collection
- Keywords
- aggressive periodontitis, healthy peri-implant, chairside test, chronic periodontitis
- Medical subject headings
- Periodontal Diseases, Aggressive Periodontitis, Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GCF collection with aMMP-8 chair side testDiagnostic test
Saliva collectionOther
| Study group | Role | What they receive |
|---|---|---|
| Chronic periodontitis | This groups participant has radiographically moderate alveolar bone loss, CAL > 5 mm and PD >6 mm in several sites of each quadrant Receives: Diagnostic Test: GCF collection with aMMP-8 chair side test; Other: Saliva collection | |
| Generalized aggressive periodontitis | This demonstrated a generalized pattern of severe breakdown and CAL > 5 mm and PD > 6 mm on 8 > teeth; minimum three of those were other than first incisors or first molars Receives: Diagnostic Test: GCF collection with aMMP-8 chair side test; Other: Saliva collection | |
| Gingivitis | This group has varying degrees of gingival inflammation, with CAL < 2 mm, without any radiographical bone loss due to periodontitis Receives: Diagnostic Test: GCF collection with aMMP-8 chair side test; Other: Saliva collection | |
| Implant | Implants classified PD < 5 mm, no bleeding on probing, no suppuration and no radiographic bone loss > 0.5 mm Receives: Diagnostic Test: GCF collection with aMMP-8 chair side test; Other: Saliva collection | |
| Health | Probing depth (PD) < 3mm, no gingival recession due to periodontal disease, and clinical attachment level (CAL) < 2 mm, BOP in < 10% of full-mouth score examination Receives: Diagnostic Test: GCF collection with aMMP-8 chair side test; Other: Saliva collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
aMMP-8 levels of GCF
GCF levels measured by IFMA
Measured: 2 hours
Secondary outcomes (1)
Salivary MMP-8 levels
Saliva levels measured by IFMA
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start1 Mar 2015
- Primary completion1 Mar 2016
- Study completion1 Jun 2016
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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 103 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veli Özgen Öztürk, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527901
- Sponsor's protocol ID
- BAP-17/1
- Status last verified
- May 2016
- First submitted
- 5 May 2018
- Last updated
- 17 May 2018
- 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 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Active Matrix Metalloproteinase-8 (aMMP-8) Chair-side Test in Different Periodontal Disease and Healthy Implants
- ClinicalTrials.gov ID
- NCT03527901
- Acronym / sponsor ID
- BAP-17/1
- Conditions
- Periodontal Diseases
- Keywords
- aggressive periodontitis, healthy peri-implant, chairside test, chronic periodontitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 1 Mar 2016 (actual)
- Study completion
- 1 Jun 2016 (actual)
- First posted
- 17 May 2018 (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 aim of this study to evaluate the diagnostic accuracy of a new qualitative aMMP-8 POC test in different periodontal health and disease and as compared to the established quantitative laboratory method (ELISA)
Detailed description
MMP-8 has been reported to reflect the inflammatory status in periodontal tissues and, therefore represent as potential biomarkers of periodontitis. A positive aMMP-8 test could be an early indicator of these excessive and undesired tissue reactions.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 12 Months
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Chronic periodontitis | – | Diagnostic Test: GCF collection with aMMP-8 chair side test, Other: Saliva collectionThis groups participant has radiographically moderate alveolar bone loss, CAL > 5 mm and PD >6 mm in several sites of each quadrant |
| Generalized aggressive periodontitis | – | Diagnostic Test: GCF collection with aMMP-8 chair side test, Other: Saliva collectionThis demonstrated a generalized pattern of severe breakdown and CAL > 5 mm and PD > 6 mm on 8 > teeth; minimum three of those were other than first incisors or first molars |
| Gingivitis | – | Diagnostic Test: GCF collection with aMMP-8 chair side test, Other: Saliva collectionThis group has varying degrees of gingival inflammation, with CAL < 2 mm, without any radiographical bone loss due to periodontitis |
| Implant | – | Diagnostic Test: GCF collection with aMMP-8 chair side test, Other: Saliva collectionImplants classified PD < 5 mm, no bleeding on probing, no suppuration and no radiographic bone loss > 0.5 mm |
| Health | – | Diagnostic Test: GCF collection with aMMP-8 chair side test, Other: Saliva collectionProbing depth (PD) < 3mm, no gingival recession due to periodontal disease, and clinical attachment level (CAL) < 2 mm, BOP in < 10% of full-mouth score examination |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- All participants have minimum 20 teeth
Key inclusion criteria (2 listed)
- Systemically healthy
- Nonsmokers
Key exclusion criteria (3 listed)
- Participants were not included if they had systemic disease such as diabetes, cardiovascular.
- Participants who took regular medications that could affect of periodontal tissue
- Participants who received antibiotics less than 10 weeks before the study
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 |
|---|---|---|
| GCF collection with aMMP-8 chair side test | Diagnostic test | Chronic periodontitis, Generalized aggressive periodontitis, Gingivitis, Health, Implant |
| Saliva collection | Other | Chronic periodontitis, Generalized aggressive periodontitis, Gingivitis, Health, Implant |
Primary outcome
aMMP-8 levels of GCF
Time frame: 2 hours
GCF levels measured by IFMA
1 secondary outcome
Salivary MMP-8 levels
Time frame: 2 hours
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 17 May 2018.
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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, run by Aydin Adnan Menderes University.
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 2 inclusion and 3 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 17 May 2018. 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?
aMMP-8 levels of GCF (time frame: 2 hours). 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 May 2018.