PeriodontitisNCT07628803
Relationship Between Periodontal Inflammation Severity and Pan-Immune System Inflammation Value
An observational study of Periodontitis and Gingivitis, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
This cross-sectional observational study aims to evaluate the relationship between periodontal inflammation severity and the Pan-Immune-Inflammation Value (PIV) in systemically healthy adults. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Gingivitis, Periodontal Health
- Type of treatment
- Injection or infusion
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2025to 15 May 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Systemically healthy adults aged 18 years and older who present to the Department of Periodontology, Faculty of Dentistry, Bolu Abant Izzet Baysal University, and who are diagnosed as periodontally healthy, having gingivitis, or having Stage III-IV periodontitis according to the 2017 World Workshop Classification of Periodontal and Peri-Implant Diseases and Conditions.
Who may be able to join
- Age 18 years and older
- Systemically healthy individuals
- Complete blood count performed within the previous 3 months
- Diagnosis of periodontal health, gingivitis, or Stage III-IV periodontitis according to the 2017 World Workshop Classification of Periodontal and Peri-Implant Diseases and Conditions
- Willingness to provide written informed consent
Who cannot join
- Pregnancy or lactation- History of systemic diseases that may affect periodontal tissues
- Use of antibiotics or anti-inflammatory drugs within the previous 3 months
- Periodontal treatment within the previous 6 months
- Presence of infectious diseases such as HIV, hepatitis B, or tuberculosis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Dentistry, Bolu Abant İzzet Baysal University, Department of Periodontics
Bolu, Central, 14100
About this study
Official title: Evaluatıon Of The Relatıonshıp Between Perıodontal Inflammatıon Severıty And Pan-Immune System Inflammatıon Value
This cross-sectional observational study aims to evaluate the relationship between periodontal inflammation severity and the Pan-Immune-Inflammation Value (PIV) in systemically healthy adults. A total of 160 participants will be recruited from the Department of Periodontology, Faculty of Dentistry, Bolu Abant Izzet Baysal University. Clinical periodontal parameters and Periodontal Inflamed Surface Area (PISA) will be recorded, and their association with PIV calculated from complete blood count parameters will be analyzed.
Read the detailed description
Periodontitis is a chronic inflammatory disease that leads to progressive destruction of the tooth-supporting tissues and contributes to systemic inflammatory burden. Periodontal Inflamed Surface Area (PISA) is a validated quantitative measure that estimates the total inflamed periodontal surface area and reflects the inflammatory burden associated with periodontal disease.
The Pan-Immune-Inflammation Value (PIV) is a novel composite biomarker calculated from complete blood count parameters using the following formula: neutrophil count × platelet count × monocyte count / lymphocyte count. PIV has been proposed as a comprehensive indicator of systemic inflammation.
This cross-sectional observational study aims to investigate the relationship between PISA and PIV in systemically healthy adults.
A total of 160 participants aged 18 years and older will be recruited from the Department of Periodontology, Faculty of Dentistry, Bolu Abant Izzet Baysal University. Participants will be classified as periodontally healthy, gingivitis, or periodontitis according to the 2017 World Workshop Classification of Periodontal and Peri-Implant Diseases and Conditions.
Clinical periodontal parameters, including Plaque Index, Gingival Index, Papillary Bleeding Index, Probing Pocket Depth, Clinical Attachment Loss, Bleeding on Probing, and PISA, will be recorded by a single calibrated examiner.
Complete blood count results obtained within the previous three months will be used to calculate PIV.
The primary objective is to evaluate the association between PISA and PIV. Secondary objectives include assessing the relationships between PIV and other periodontal clinical parameters.
An a priori power analysis performed using G*Power indicated that at least 84 participants were required to detect a moderate correlation (r = 0.30) with 80% power at a significance level of 0.05. To allow subgroup analyses and potential exclusions, 160 participants will be enrolled.
Statistical analyses will be conducted using SPSS software, and statistical significance will be set at p < 0.05.
- Conditions
- Periodontitis, Gingivitis, Periodontal Health
- Keywords
- Periodontal Inflamed Surface Area, PISA, Pan-Immune-Inflammation Value, PIV, Systemic Inflammation, Complete Blood Count, Periodontal Disease
- Medical subject headings
- Periodontitis, Gingivitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Periodontitis | Systemically healthy individuals diagnosed with Stage III or Stage IV periodontitis according to the 2017 World Workshop Classification of Periodontal and Peri-Implant Diseases and Conditions. | |
| Gingivitis | Systemically healthy individuals with gingival inflammation without clinical attachment loss consistent with periodontitis. | |
| Periodontally Healthy | Systemically healthy individuals with clinically healthy periodontal tissues and no evidence of periodontitis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between Periodontal Inflamed Surface Area and Pan-Immune-Inflammation Value
The correlation between Periodontal Inflamed Surface Area and Pan-Immune-Inflammation Value will be evaluated. Periodontal Inflamed Surface Area will be calculated using periodontal clinical measurements, including probing pocket depth, gingival recession, and bleeding on probing, and will be expressed in square millimeters. Pan-Immune-Inflammation Value will be calculated from complete blood count parameters using the formula: neutrophil count × platelet count × monocyte count / lymphocyte count.Correlation coefficient between Periodontal Inflamed Surface Area and Pan-Immune-Inflammation Value.
Measured: Baseline (single visit)
Secondary outcomes (5)
Correlation between Periodontal Inflamed Surface Area and Systemic Immune-Inflammation Index
The correlation between Periodontal Inflamed Surface Area and Systemic Immune-Inflammation Index will be evaluated. Periodontal Inflamed Surface Area will be calculated using periodontal clinical measurements, including probing pocket depth, gingival recession, and bleeding on probing, and will be expressed in square millimeters. Systemic Immune-Inflammation Index will be calculated from complete blood count parameters using the formula: platelet count × neutrophil count / lymphocyte count.
Measured: Baseline (single visit)
Correlation between Periodontal Inflamed Surface Area and Systemic Inflammation Response Index
The correlation between Periodontal Inflamed Surface Area and Systemic Inflammation Response Index will be evaluated. Periodontal Inflamed Surface Area will be calculated using periodontal clinical measurements, including probing pocket depth, gingival recession, and bleeding on probing, and will be expressed in square millimeters. Systemic Inflammation Response Index will be calculated from complete blood count parameters using the formula: neutrophil count × monocyte count / lymphocyte count.Correlation coefficient between Periodontal Inflamed Surface Area and Systemic Inflammation Response Index.
Measured: Baseline (single visit)
Periodontal Inflamed Surface Area
Periodontal Inflamed Surface Area will be calculated using periodontal clinical measurements, including probing pocket depth, gingival recession, and bleeding on probing. The value will represent the total inflamed periodontal surface area and will be expressed in square millimeters.Periodontal Inflamed Surface Area in square millimeters.
Measured: Baseline, single visit.
Systemic Immune-Inflammation Index
Systemic Immune-Inflammation Index will be calculated from complete blood count parameters using the formula: platelet count × neutrophil count / lymphocyte count. This value will be used as a systemic inflammatory index.Systemic Immune-Inflammation Index calculated from complete blood count parameters.
Measured: Baseline, single visit.
Systemic Inflammation Response Index
Systemic Inflammation Response Index will be calculated from complete blood count parameters using the formula: neutrophil count × monocyte count / lymphocyte count. This value will be used as a systemic inflammatory index.
Measured: Baseline, single visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start15 Dec 2025
- Primary completion15 May 2026
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep AKGÜL, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07628803
- Sponsor's protocol ID
- BAİBU-Perio-ZA-01
- Status last verified
- Jun 2026
- First submitted
- 22 May 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be publicly shared to protect participant confidentiality. De-identified and aggregated data may be available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluatıon Of The Relatıonshıp Between Perıodontal Inflammatıon Severıty And Pan-Immune System Inflammatıon Value
- ClinicalTrials.gov ID
- NCT07628803
- Acronym / sponsor ID
- BAİBU-Perio-ZA-01
- Conditions
- Periodontitis, Gingivitis, Periodontal Health
- Keywords
- Periodontal Inflamed Surface Area, PISA, Pan-Immune-Inflammation Value, PIV, Systemic Inflammation, Complete Blood Count, Periodontal Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 5 Jun 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 observational study aims to evaluate the relationship between periodontal inflammation severity and the Pan-Immune-Inflammation Value (PIV) in systemically healthy adults. A total of 160 participants will be recruited from the Department of Periodontology, Faculty of Dentistry, Bolu Abant Izzet Baysal University. Clinical periodontal parameters and Periodontal Inflamed Surface Area (PISA) will be recorded, and their association with PIV calculated from complete blood count parameters will be analyzed.
Detailed description
Periodontitis is a chronic inflammatory disease that leads to progressive destruction of the tooth-supporting tissues and contributes to systemic inflammatory burden. Periodontal Inflamed Surface Area (PISA) is a validated quantitative measure that estimates the total inflamed periodontal surface area and reflects the inflammatory burden associated with periodontal disease.
The Pan-Immune-Inflammation Value (PIV) is a novel composite biomarker calculated from complete blood count parameters using the following formula: neutrophil count × platelet count × monocyte count / lymphocyte count. PIV has been proposed as a comprehensive indicator of systemic inflammation.
This cross-sectional observational study aims to investigate the relationship between PISA and PIV in systemically healthy adults.
A total of 160 participants aged 18 years and older will be recruited from the Department of Periodontology, Faculty of Dentistry, Bolu Abant Izzet Baysal University. Participants will be classified as periodontally healthy, gingivitis, or periodontitis according to the 2017 World Workshop Classification of Periodontal and Peri-Implant Diseases and Conditions.
Clinical periodontal parameters, including Plaque Index, Gingival Index, Papillary Bleeding Index, Probing Pocket Depth, Clinical Attachment Loss, Bleeding on Probing, and PISA, will be recorded by a single calibrated examiner.
Complete blood count results obtained within the previous three months will be used to calculate PIV.
The primary objective is to evaluate the association between PISA and PIV. Secondary objectives include assessing the relationships between PIV and other periodontal clinical parameters.
An a priori power analysis performed using G*Power indicated that at least 84 participants were required to detect a moderate correlation (r = 0.30) with 80% power at a significance level of 0.05. To allow subgroup analyses and potential exclusions, 160 participants will be enrolled.
Statistical analyses will be conducted using SPSS software, and statistical significance will be set at p < 0.05.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Periodontitis | – | –Systemically healthy individuals diagnosed with Stage III or Stage IV periodontitis according to the 2017 World Workshop Classification of Periodontal and Peri-Implant Diseases and Conditions. |
| Gingivitis | – | –Systemically healthy individuals with gingival inflammation without clinical attachment loss consistent with periodontitis. |
| Periodontally Healthy | – | –Systemically healthy individuals with clinically healthy periodontal tissues and no evidence of periodontitis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Systemically healthy adults aged 18 years and older who present to the Department of Periodontology, Faculty of Dentistry, Bolu Abant Izzet Baysal University, and who are diagnosed as periodontally healthy, having gingivitis, or having Stage III-IV periodontitis according to the 2017 World Workshop Classification of Periodontal and Peri-Implant Diseases and Conditions.
Key inclusion criteria (5 listed)
- Age 18 years and older
- Systemically healthy individuals
- Complete blood count performed within the previous 3 months
- Diagnosis of periodontal health, gingivitis, or Stage III-IV periodontitis according to the 2017 World Workshop Classification of Periodontal and Peri-Implant Diseases and Conditions
- Willingness to provide written informed consent
Key exclusion criteria (4 listed)
- Pregnancy or lactation- History of systemic diseases that may affect periodontal tissues
- Use of antibiotics or anti-inflammatory drugs within the previous 3 months
- Periodontal treatment within the previous 6 months
- Presence of infectious diseases such as HIV, hepatitis B, or tuberculosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between Periodontal Inflamed Surface Area and Pan-Immune-Inflammation Value
Time frame: Baseline (single visit)
The correlation between Periodontal Inflamed Surface Area and Pan-Immune-Inflammation Value will be evaluated. Periodontal Inflamed Surface Area will be calculated using periodontal clinical measurements, including probing pocket depth, gingival recession, and bleeding on probing, and will be expressed in square millimeters. Pan-Immune-Inflammation Value will be calculated from complete blood count parameters using the formula: neutrophil count × platelet count × monocyte count / lymphocyte count.Correlation coefficient between Periodontal Inflamed Surface Area and Pan-Immune-Inflammation Value.
5 secondary outcomes
Correlation between Periodontal Inflamed Surface Area and Systemic Immune-Inflammation Index
Time frame: Baseline (single visit)
Correlation between Periodontal Inflamed Surface Area and Systemic Inflammation Response Index
Time frame: Baseline (single visit)
Periodontal Inflamed Surface Area
Time frame: Baseline, single visit.
Systemic Immune-Inflammation Index
Time frame: Baseline, single visit.
Systemic Inflammation Response Index
Time frame: Baseline, single visit.
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 5 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be publicly shared to protect participant confidentiality. De-identified and aggregated data may be 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 Periodontitis and Gingivitis, run by Abant Izzet Baysal 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 5 inclusion and 4 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 5 Jun 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?
Correlation between Periodontal Inflamed Surface Area and Pan-Immune-Inflammation Value (time frame: Baseline (single visit)). 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 5 Jun 2026.