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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Turkey (Türkiye)
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Smoking Group
Patients who are current smokers or use tobacco products
Other: Clinical and Radiographic Periodontal Assessment
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
Other: Clinical and Radiographic Periodontal Assessment
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
Other: Clinical and Radiographic Periodontal Assessment
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
Other: Clinical and Radiographic Periodontal Assessment
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
Other: Clinical and Radiographic Periodontal Assessment
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Inonu University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 11, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 20, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 23, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026/9630

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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