The Effect of Systemic Factors on Peri-implant Health Status and Clinical Indices

April 8, 2026 updated by: Ömer Alperen Kırmızıgül, Inonu University

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

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.

Study Overview

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 Type

Observational

Enrollment (Actual)

93

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Malatya
      • Battalgazi, Malatya, Turkey (Türkiye), 44300
        • Inonu University Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population consists of patients who visited the Department of Periodontology at Inonu University Faculty of Dentistry. The sample includes systemically healthy individuals and patients diagnosed with diabetes mellitus, cardiovascular disease, or osteoporosis, as well as current smokers.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Smoking Group
Patients who are current smokers or use tobacco products
Clinical parameters (Plaque Index, Gingival Index, Probing Depth) and radiographic assessments were performed for each patient to determine peri-implant health status
Diabetes Mellitus Group
Patients diagnosed with diabetes mellitus
Clinical parameters (Plaque Index, Gingival Index, Probing Depth) and radiographic assessments were performed for each patient to determine peri-implant health status
Cardiovascular Disease Group
Patients with a history of cardiovascular diseases
Clinical parameters (Plaque Index, Gingival Index, Probing Depth) and radiographic assessments were performed for each patient to determine peri-implant health status
Osteoporosis Group
Patients diagnosed with osteoporosis
Clinical parameters (Plaque Index, Gingival Index, Probing Depth) and radiographic assessments were performed for each patient to determine peri-implant health status
Systemically Healthy Group
Individuals with no systemic diseases and no history of smoking
Clinical parameters (Plaque Index, Gingival Index, Probing Depth) and radiographic assessments were performed for each patient to determine peri-implant health status

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingival Index (GI)
Time Frame: At least 3 years after implant loading
Assessment of Gingival Index (GI) to evaluate the inflammatory status of peri-implant tissues.
At least 3 years after implant loading
Plaque Index (PI)
Time Frame: At least 3 years after implant loading.
Assessment of Plaque Index (PI) to evaluate the plaque accumulation around peri-implant tissues.
At least 3 years after implant loading.
Probing Depth (PD)
Time Frame: At least 3 years after implant loading.
Assessment of Probing Depth (PD) to evaluate the pocket depth around peri-implant tissues.
At least 3 years after implant loading.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2026

Primary Completion (Actual)

March 20, 2026

Study Completion (Actual)

March 23, 2026

Study Registration Dates

First Submitted

March 23, 2026

First Submitted That Met QC Criteria

April 8, 2026

First Posted (Actual)

April 15, 2026

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The de-identified individual participant data (IPD) that support the findings of this study are available from the corresponding author upon reasonable request

IPD Sharing Time Frame

Data will be available beginning 6 months and ending 36 months following publication

IPD Sharing Access Criteria

Requests for data should be directed to the corresponding author via email. To gain access, data requestors will need to provide a methodologically sound proposal

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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