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

NCT ID: NCT03527901

Last Updated: 2018-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

103 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-01

Study Completion Date

2016-06-01

Brief Summary

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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

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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

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Periodontal Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Chronic periodontitis

This groups participant has radiographically moderate alveolar bone loss, CAL \> 5 mm and PD \>6 mm in several sites of each quadrant

GCF collection with aMMP-8 chair side test

Intervention Type DIAGNOSTIC_TEST

Saliva collection

Intervention Type OTHER

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

GCF collection with aMMP-8 chair side test

Intervention Type DIAGNOSTIC_TEST

Saliva collection

Intervention Type OTHER

Gingivitis

This group has varying degrees of gingival inflammation, with CAL \< 2 mm, without any radiographical bone loss due to periodontitis

GCF collection with aMMP-8 chair side test

Intervention Type DIAGNOSTIC_TEST

Saliva collection

Intervention Type OTHER

Implant

Implants classified PD \< 5 mm, no bleeding on probing, no suppuration and no radiographic bone loss \> 0.5 mm

GCF collection with aMMP-8 chair side test

Intervention Type DIAGNOSTIC_TEST

Saliva collection

Intervention Type OTHER

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

GCF collection with aMMP-8 chair side test

Intervention Type DIAGNOSTIC_TEST

Saliva collection

Intervention Type OTHER

Interventions

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GCF collection with aMMP-8 chair side test

Intervention Type DIAGNOSTIC_TEST

Saliva collection

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aydin Adnan Menderes University

OTHER

Sponsor Role lead

Responsible Party

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Veli Özgen Öztürk

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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BAP-17/1

Identifier Type: -

Identifier Source: org_study_id

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