- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07530211
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
Completed
Intervention / Treatment
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.
Sponsor
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
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Bone Diseases
- Musculoskeletal Diseases
- Periodontal Diseases
- Mouth Diseases
- Stomatognathic Diseases
- Metabolic Diseases
- Glucose Metabolism Disorders
- Bone Diseases, Metabolic
- Behavior
- Nutritional and Metabolic Diseases
- Cardiovascular Diseases
- Osteoporosis
- Diabetes Mellitus
- Peri-Implantitis
- Smoking
Other Study ID 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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