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

NCT03527901 | Completed

• 1 other identifier: BAP-17/1
• Study Type: observational
• Target: 103
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Periodontal Diseases

Keywords

aggressive periodontitis; healthy peri-implant; chairside test; chronic periodontitis

Outcome Measures

Primary Outcomes (1)

• aMMP-8 levels of GCF

  GCF levels measured by IFMA

  2 hours

Secondary Outcomes (1)

• Salivary MMP-8 levels

  2 hours

Study Arms (5)

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

Interventions

GCF collection with aMMP-8 chair side test DIAGNOSTIC_TEST

Chronic periodontitis; Generalized aggressive periodontitis; Gingivitis; Health; Implant

Saliva collection OTHER

Chronic periodontitis; Generalized aggressive periodontitis; Gingivitis; Health; Implant

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All participants have minimum 20 teeth

You may qualify if:

• Systemically healthy
• Nonsmokers

You may not qualify if:

• 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

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

MeSH Terms

Conditions

Periodontal Diseases; Aggressive Periodontitis; Chronic Periodontitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Periodontitis; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 5, 2018
• First Posted: May 17, 2018
• Study Start: March 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: June 1, 2016
• Last Updated: May 17, 2018

Record last verified: 2016-05