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Clinical Trials/NCT07530211
NCT07530211
Completed
Not Applicable

The Effect of Systemic Factors on Peri-implant Health Status and Clinical Indices: A Cross-sectional Study

Inonu University1 site in 1 country93 target enrollmentStarted: March 11, 2026Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
93
Locations
1
Primary Endpoint
Prevalence of Peri-implant Diseases

Overview

Brief Summary

This cross-sectional study evaluates the impact of systemic risk factors, including diabetes mellitus, smoking, cardiovascular disease, and osteoporosis, on peri-implant health status and clinical indices. The study included 93 patients with a total of 314 implants that have been in function for at least three years. The primary goal is to determine how these systemic conditions influence the prevalence of peri-implant mucositis and peri-implantitis.

Detailed Description

Clinical parameters, including Gingival Index (GI), Plaque Index (PI), and Probing Depth (PD), were measured using a standard periodontal probe. Radiographic assessments were performed to evaluate bone loss in accordance with European Periodontology Workshop guidelines. Peri-implant health status was categorized into three groups: healthy, peri-implant mucositis, and peri-implantitis. Data analysis was conducted using chi-square and Mann-Whitney U tests to examine the associations between systemic factors and peri-implant tissues.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
27 Years to 72 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Patients with at least one dental implant in function for at least three years.
  • Patients aged between 27 and 72 years.
  • Availability of complete clinical and radiographic records.

Exclusion Criteria

  • Implants in function for less than 3 years.
  • Pregnancy or lactation.
  • History of radiation therapy in the head and neck region

Arms & Interventions

Osteoporosis Group

Patients diagnosed with osteoporosis

Intervention: Clinical and Radiographic Periodontal Assessment (Other)

Systemically Healthy Group

Individuals with no systemic diseases and no history of smoking

Intervention: Clinical and Radiographic Periodontal Assessment (Other)

Diabetes Mellitus Group

Patients diagnosed with diabetes mellitus

Intervention: Clinical and Radiographic Periodontal Assessment (Other)

Cardiovascular Disease Group

Patients with a history of cardiovascular diseases

Intervention: Clinical and Radiographic Periodontal Assessment (Other)

Smoking Group

Patients who are current smokers or use tobacco products

Intervention: Clinical and Radiographic Periodontal Assessment (Other)

Outcomes

Primary Outcomes

Prevalence of Peri-implant Diseases

Time Frame: Minimum 3 years post-loading veya At clinical assessment, at least 3 years after implant loading

Distribution of dental implants categorized into three status groups: healthy, peri-implant mucositis, and peri-implantitis based on clinical and radiographic criteria

Secondary Outcomes

  • Gingival Index (GI)(At least 3 years after implant loading)
  • Plaque Index (PI)(At least 3 years after implant loading.)
  • Probing Depth (PD)(At least 3 years after implant loading.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ömer Alperen Kırmızıgül

Assistant Professor

Inonu University

Study Sites (1)

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