Peri-implantitis and MMP-8

NCT05711407 | Completed DMC

• 1 other identifier: Frag3
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Peri-implantitis is defined as the pathological condition around dental implants characterized by inflammation in the peri-implant mucosa and progressive bone loss, eventually leading to implant loss. Peri-implantitis is thought to be a disease analogous to periodontitis with a prevalence reaching 22%. Though peri-implantitis is readily recognized as a part of modern dentistry, the exact etiology or an effective treatment regimen hasn't been established yet. Thus, contemporary research is orientating toward acknowledging the aetiologic and risk factors of the disease and of course establishing prognostic markers for disease prevention. Microbiota residing in the subgingival plaque are considered the main etiologic factor of the disease, however, current literature has not concluded on the exact microbial composition of peri-implant lesions. In addition, genetic predisposition has been recognized as a risk factor for disease initiation and progression and several observational studies have addressed the potential association between various gene polymorphisms and the occurrence of peri-implantitis. Lastly, to establish effective preventive measures, several biomarkers have been evaluated as potential diagnostic and prognostic markers of disease progression. Objectives:

1. 1.To identify the relationship of peri-implantitis with Cycloxygenase-2 (COX-2) and MMP-8 gene polymorphisms. Cyclooxygenase catalyzes the production of prostaglandins (PGs) which are an important inflammatory mediator participating in the pathogenesis of peri-implantitis. In addition, PGE2 expression in the peri-implant crevicular fluid will be assessed.
2. 2.To characterize the microbiota associated with peri-implantitis lesions, using novel identification techniques enabling the identification of specific opportunistic bacteria associated with the disease.
3. 3.To test the diagnostic accuracy of a modern chairside test, using metalloproteinase-8 (MMP-8), an enzyme implicated in the pathogenesis of the disease, as a biomarker of disease progression.

Conditions

Peri-Implantitis

Outcome Measures

Primary Outcomes (1)

• Gene polymorphisms of MMP-8

  3 years

Study Arms (2)

Peri-implantitis

Group Case

Genetic: Gene Polymorphisms of MMP-8

Healthy

Group Control

Genetic: Gene Polymorphisms of MMP-8

Interventions

Gene Polymorphisms of MMP-8 GENETIC

Saliva Samples

Healthy; Peri-implantitis

Eligibility Criteria

• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A study sample of minimum 100 patients attending the Postgraduate Clinic of Periodontology and Implant Biology of Dental School Aristotle University of Thessaloniki for periodontal or peri-implant treatment, will be recruited. Patients should be diagnosed with peri-implantitis according the latest (2017)(4) criteria.

You may qualify if:

• Screw Retained implant restorations
• Loaded for \> 12 months
• Patients Treated for Periodontal Disease

You may not qualify if:

• months patients should have not received antibiotics
• Diabetes and immunosuppressant diseases
• Periodontal maintenance in the previous 3 months

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Aristotle Un

Thessaloniki, 54124, Greece

Location

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Dimitra Sakellari

  Aristotle University Of Thessaloniki

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 3, 2023
• Study Start: March 3, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)