Peri-implantitisNCT07530211
The Effect of Systemic Factors on Peri-implant Health Status and Clinical Indices
An observational study of Peri-implantitis and Dental Implants, run by Inonu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 27 to 72 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-implantitis, Dental Implants, Peri-implant Mucositis
- What is being tested?
- Clinical and Radiographic Periodontal Assessment
- How many people
- 93 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Mar 2026to 23 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 27 to 72 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Implants in function for less than 3 years.
- Pregnancy or lactation.
- History of radiation therapy in the head and neck region
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Inonu University Faculty of Dentistry
Battalgazi, Malatya, 44300
About this study
Official title: 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.
Read the 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.
- Conditions
- Peri-implantitis, Dental Implants, Peri-implant Mucositis
- Being tested
- Clinical and Radiographic Periodontal Assessment
- Keywords
- Diabetes Mellitus, Smoking, Cardiovascular Disease, Osteoporosis, Peri-implant Health
- Medical subject headings
- Peri-Implantitis, Diabetes Mellitus, Smoking, Cardiovascular Diseases, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical and Radiographic Periodontal AssessmentOther
Clinical parameters (Plaque Index, Gingival Index, Probing Depth) and radiographic assessments were performed for each patient to determine peri-implant health status
| Study group | Role | What they receive |
|---|---|---|
| Smoking Group | Patients who are current smokers or use tobacco products Receives: Other: Clinical and Radiographic Periodontal Assessment | |
| Diabetes Mellitus Group | Patients diagnosed with diabetes mellitus Receives: Other: Clinical and Radiographic Periodontal Assessment | |
| Cardiovascular Disease Group | Patients with a history of cardiovascular diseases Receives: Other: Clinical and Radiographic Periodontal Assessment | |
| Osteoporosis Group | Patients diagnosed with osteoporosis Receives: Other: Clinical and Radiographic Periodontal Assessment | |
| Systemically Healthy Group | Individuals with no systemic diseases and no history of smoking Receives: Other: Clinical and Radiographic Periodontal Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Peri-implant Diseases
Distribution of dental implants categorized into three status groups: healthy, peri-implant mucositis, and peri-implantitis based on clinical and radiographic criteria
Measured: Minimum 3 years post-loading veya At clinical assessment, at least 3 years after implant loading
Secondary outcomes (3)
Gingival Index (GI)
Assessment of Gingival Index (GI) to evaluate the inflammatory status of peri-implant tissues.
Measured: At least 3 years after implant loading
Plaque Index (PI)
Assessment of Plaque Index (PI) to evaluate the plaque accumulation around peri-implant tissues.
Measured: At least 3 years after implant loading.
Probing Depth (PD)
Assessment of Probing Depth (PD) to evaluate the pocket depth around peri-implant tissues.
Measured: At least 3 years after implant loading.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start11 Mar 2026
- Primary completion20 Mar 2026
- Study completion23 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implantitisStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ömer Alperen Kırmızıgül, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530211
- Sponsor's protocol ID
- 2026/9630
- Status last verified
- Apr 2026
- First submitted
- 23 Mar 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified individual participant data (IPD) that support the findings of this study are available from the corresponding author upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Systemic Factors on Peri-implant Health Status and Clinical Indices: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT07530211
- Acronym / sponsor ID
- 2026/9630
- Conditions
- Peri-implantitis, Dental Implants, Peri-implant Mucositis
- Keywords
- Diabetes Mellitus, Smoking, Cardiovascular Disease, Osteoporosis, Peri-implant Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 11 Mar 2026 (actual)
- Primary completion
- 20 Mar 2026 (actual)
- Study completion
- 23 Mar 2026 (actual)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Smoking Group | – | Other: Clinical and Radiographic Periodontal AssessmentPatients who are current smokers or use tobacco products |
| Diabetes Mellitus Group | – | Other: Clinical and Radiographic Periodontal AssessmentPatients diagnosed with diabetes mellitus |
| Cardiovascular Disease Group | – | Other: Clinical and Radiographic Periodontal AssessmentPatients with a history of cardiovascular diseases |
| Osteoporosis Group | – | Other: Clinical and Radiographic Periodontal AssessmentPatients diagnosed with osteoporosis |
| Systemically Healthy Group | – | Other: Clinical and Radiographic Periodontal AssessmentIndividuals with no systemic diseases and no history of smoking |
Who may qualify
- Ages
- 27 to 72 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Implants in function for less than 3 years.
- Pregnancy or lactation.
- History of radiation therapy in the head and neck region
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical and Radiographic Periodontal AssessmentClinical parameters (Plaque Index, Gingival Index, Probing Depth) and radiographic assessments were performed for each patient to determine peri-implant health status | Other | Cardiovascular Disease Group, Diabetes Mellitus Group, Osteoporosis Group, Smoking Group, Systemically Healthy Group |
Primary outcome
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
3 secondary outcomes
Gingival Index (GI)
Time frame: At least 3 years after implant loading
Plaque Index (PI)
Time frame: At least 3 years after implant loading.
Probing Depth (PD)
Time frame: At least 3 years after implant loading.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: Yes. The de-identified individual participant data (IPD) that support the findings of this study are available from the corresponding author upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peri-implantitis and Dental Implants, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Peri-implant Diseases (time frame: Minimum 3 years post-loading veya At clinical assessment, at least 3 years after implant loading). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.