- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04268381
Oral and Systemic aMMP-8 in Periodontal Disease
July 10, 2020 updated by: Zeynep Pinar KELES YUCEL, Aydin Adnan Menderes University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
83
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Aydın, Turkey
- Aydin Adnan Menderes University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- having any systemic disease
- smoking
- pregnancy or lactation
- using antibiotic or any anti-inflammatory drug or any periodontal treatment within the past 6 months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy (n=23)
|
aMMP-8 is measured by immunofluorometric assay (IFMA).
|
Gingivitis (n=20)
|
aMMP-8 is measured by immunofluorometric assay (IFMA).
|
Periodontitis (n=40)
|
aMMP-8 is measured by immunofluorometric assay (IFMA).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
through study completion, an average of 4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Zeynep Pinar Keles Yucel, Department of Periodontology, School of Dentistry, Giresun University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 20, 2020
Primary Completion (Actual)
March 20, 2020
Study Completion (Actual)
March 20, 2020
Study Registration Dates
First Submitted
February 10, 2020
First Submitted That Met QC Criteria
February 12, 2020
First Posted (Actual)
February 13, 2020
Study Record Updates
Last Update Posted (Actual)
July 14, 2020
Last Update Submitted That Met QC Criteria
July 10, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-2T/39
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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