Oral and Systemic aMMP-8 in Periodontal Disease

NCT04268381 | Completed

• 1 other identifier: 20-2T/39
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

Periodontal disease is an inflammatory process that can result in tooth loss and also is considered a modifying factor for systemic health. Matrix metalloproteinase (MMP)-8 is the major collagenase of periodontal tissue breakdown. The aim of the present study is to analyze active (aMMP-8) levels in gingival crevicular fluid (GCF), saliva and serum in the context of new criteria of gingivitis and stage 3 grade C periodontitis.

Conditions

Periodontal Diseases; Periodontal Inflammation

Keywords

periodontitis; gingivitis; matrix metalloproteinases

Outcome Measures

Primary Outcomes (1)

• Oral (GCF and saliva) and serum levels of aMMP-8 in periodontitis and gingivitis

  aMMP-8 levels

  through study completion, an average of 4 months

Study Arms (3)

Healthy (n=23)

Other: Biochemical analysis

Gingivitis (n=20)

Other: Biochemical analysis

Periodontitis (n=40)

Other: Biochemical analysis

Interventions

Biochemical analysis OTHER

aMMP-8 is measured by immunofluorometric assay (IFMA).

Gingivitis (n=20); Healthy (n=23); Periodontitis (n=40)

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy controls (n=23) includes volunteers with clinically healthy periodontium who had BOP \< 10% and PD ≤ 3 mm, no sites with \> 1 mm attachment loss, no radiographic sign of alveolar bone destruction and no history of periodontitis. Gingivitis patients (n=20) shows PD ≤ 3 mm with BOP \> 50% in the entire mouth as well as no clinical attachment loss or alveolar bone loss. Periodontitis patients (Generalized Stage 3) have interdental CAL ≥ 5 mm at least 2 non-adjacent teeth, PD ≥ 6 mm and radiographic bone loss affecting 30% of the teeth or more.They show also no more than 4 teeth loss due to periodontitis.

You may qualify if:

• systemically healthy and non-smoker individuals aged 25 to 50 years
• having ≥20 teeth present (except third molars)
• individuals with periodontally healthy, gingivitis and stage 3 periodontitis diagnoses

You may not qualify if:

• having any systemic disease
• smoking
• pregnancy or lactation
• using antibiotic or any anti-inflammatory drug or any periodontal treatment within the past 6 months.

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead
• Giresun University: collaborator

Study Sites (1)

Aydin Adnan Menderes University

Aydin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis; Gingivitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases

Study Officials

• Zeynep Pinar Keles Yucel

  Department of Periodontology, School of Dentistry, Giresun University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Prof.

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 13, 2020
• Study Start: January 20, 2020
• Primary Completion: March 20, 2020
• Study Completion: March 20, 2020
• Last Updated: July 14, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)