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

Completed

• Conditions: Periodontal Diseases
• Interventions: Diagnostic Test: GCF collection with aMMP-8 chair side test; Other: Saliva collection

• Registration Number: NCT03527901
• Lead Sponsor: Aydin Adnan Menderes University

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 Timeline

• Study Start: 2015-03-01
• Primary Completion: 2016-03-01
• Status Verified: 2016-05
• Study Completion: 2016-06-01
• Study First Submitted: 2018-05-05
• Study First Submitted QC: 2018-05-16
• Last Update Submitted: 2018-05-16
• Study First Posted: 2018-05-17
• Last Update Posted: 2018-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic periodontitis	Saliva collection	This groups participant has radiographically moderate alveolar bone loss, CAL \> 5 mm and PD \>6 mm in several sites of each quadrant
Chronic periodontitis	GCF collection with aMMP-8 chair side test	This groups participant has radiographically moderate alveolar bone loss, CAL \> 5 mm and PD \>6 mm in several sites of each quadrant
Generalized aggressive periodontitis	Saliva collection	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
Generalized aggressive periodontitis	GCF collection with aMMP-8 chair side test	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
Gingivitis	GCF collection with aMMP-8 chair side test	This group has varying degrees of gingival inflammation, with CAL \< 2 mm, without any radiographical bone loss due to periodontitis
Implant	GCF collection with aMMP-8 chair side test	Implants classified PD \< 5 mm, no bleeding on probing, no suppuration and no radiographic bone loss \> 0.5 mm
Health	Saliva collection	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
Implant	Saliva collection	Implants classified PD \< 5 mm, no bleeding on probing, no suppuration and no radiographic bone loss \> 0.5 mm
Gingivitis	Saliva collection	This group has varying degrees of gingival inflammation, with CAL \< 2 mm, without any radiographical bone loss due to periodontitis
Health	GCF collection with aMMP-8 chair side test	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

Primary Outcome Measures

Name	Time	Method
aMMP-8 levels of GCF	2 hours	GCF levels measured by IFMA

Secondary Outcome Measures

Name	Time	Method
Salivary MMP-8 levels	2 hours	Saliva levels measured by IFMA