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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

Tracking Information
First Submitted Date May 5, 2018
First Posted Date May 17, 2018
Last Update Posted Date May 17, 2018
Actual Study Start Date March 1, 2015
Actual Primary Completion Date March 1, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 16, 2018)
aMMP-8 levels of GCF [ Time Frame: 2 hours ]
GCF levels measured by IFMA
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 16, 2018)
Salivary MMP-8 levels [ Time Frame: 2 hours ]
Saliva levels measured by IFMA
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Active Matrix Metalloproteinase-8 (aMMP-8) Chair-side Test in Different Periodontal Disease
Official Title Evaluation of Active Matrix Metalloproteinase-8 (aMMP-8) Chair-side Test in Different Periodontal Disease and Healthy Implants
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)
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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration 12 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All participants have minimum 20 teeth
Condition Periodontal Diseases
Intervention
  • Diagnostic Test: GCF collection with aMMP-8 chair side test
  • Other: Saliva collection
Study Groups/Cohorts
  • Chronic periodontitis
    This groups participant has radiographically moderate alveolar bone loss, CAL > 5 mm and PD >6 mm in several sites of each quadrant
    Interventions:
    • 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
    Interventions:
    • 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
    Interventions:
    • 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
    Interventions:
    • 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
    Interventions:
    • Diagnostic Test: GCF collection with aMMP-8 chair side test
    • Other: Saliva collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 16, 2018)
103
Original Actual Enrollment Same as current
Actual Study Completion Date June 1, 2016
Actual Primary Completion Date March 1, 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03527901
Other Study ID Numbers BAP-17/1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Veli Özgen Öztürk, Aydin Adnan Menderes University
Study Sponsor Aydin Adnan Menderes University
Collaborators Not Provided
Investigators Not Provided
PRS Account Aydin Adnan Menderes University
Verification Date May 2016