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Active Matrix Metalloproteinase-8 (aMMP-8) Chair-side Test in Different Periodontal Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03527901
Recruitment Status : Completed
First Posted : May 17, 2018
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
Veli Özgen Öztürk, Aydin Adnan Menderes University

Study Description
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Brief 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)

Condition or disease Intervention/treatment
Periodontal Diseases Diagnostic Test: GCF collection with aMMP-8 chair side test Other: Saliva collection

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
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Study Type : Observational [Patient Registry]
Actual Enrollment : 103 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 12 Months
Official Title: Evaluation of Active Matrix Metalloproteinase-8 (aMMP-8) Chair-side Test in Different Periodontal Disease and Healthy Implants
Actual Study Start Date : March 1, 2015
Actual Primary Completion Date : March 1, 2016
Actual Study Completion Date : June 1, 2016
Groups and Cohorts
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Group/Cohort Intervention/treatment
Chronic periodontitis
This groups participant has radiographically moderate alveolar bone loss, CAL > 5 mm and PD >6 mm in several sites of each quadrant
 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
 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
 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
 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
 Diagnostic Test: GCF collection with aMMP-8 chair side test
Other: Saliva collection


Outcome Measures
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Primary Outcome Measures :
  1. aMMP-8 levels of GCF [ Time Frame: 2 hours ]
    GCF levels measured by IFMA


Secondary Outcome Measures :
  1. Salivary MMP-8 levels [ Time Frame: 2 hours ]
    Saliva levels measured by IFMA


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
All participants have minimum 20 teeth
Criteria

Inclusion Criteria:

  • Systemically healthy
  • Nonsmokers

Exclusion Criteria:

  • 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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Additional Information:

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Responsible Party: Veli Özgen Öztürk, Principal Investigator, Aydin Adnan Menderes University
ClinicalTrials.gov Identifier: NCT03527901    
Other Study ID Numbers: BAP-17/1
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2016

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Veli Özgen Öztürk, Aydin Adnan Menderes University:
aggressive periodontitis
healthy peri-implant
chairside test
chronic periodontitis
Additional relevant MeSH terms:
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Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases