Periodontal DiseasesNCT07397884
Markers of Bone Destruction and Oxidative Stress in Peri-implantitis
An observational study of Periodontal Diseases and Periimplant Diseases, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate and compare the levels of bone resorption (RANKL, OPG) and oxidative stress (Nitrotyrosine, NQO1) markers, along with pro-inflammatory cytokines (IL-1β), in the saliva and peri-implant sulcular fluid (PISF) of patients with peri-implantitis, periodontitis, and healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Periimplant Diseases
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2026to 20 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who apply to the University of Health Sciences, Gulhane Faculty of Dentistry, Department of Periodontology, and meet the specific clinical and radiographic criteria for peri-implantitis, periodontitis, or health.
Who may be able to join
- Systemically healthy volunteers aged 18-65. For Peri-implantitis group: Implants in function for ≥1 year, radiographic bone loss ≥ 2 mm, probing depth (PD) ≥ 5 mm, and presence of bleeding on probing (BOP) or suppuration.
- For Periodontitis group: At least one tooth with PD ≥ 4 mm, presence of BOP, and radiographic bone loss.For Healthy groups: PD ≤ 3 mm, no clinical inflammation (BOP-), and no radiographic bone loss.
- (According to the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases) -
- Exclusion Criteria:Presence of systemic diseases (e.g., diabetes, rheumatoid arthritis, osteoporosis).
- Use of antibiotics, anti-inflammatory, or immunosuppressive drugs within the last 3 months.
- Pregnancy or breastfeeding.
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- Smoking (current smokers).
- History of periodontal or peri-implant surgical treatment within the last 6 months.
- Implant failure (mobility).
- Signs of acute infection (fever, systemic symptoms).
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gülhane Faculty of Dentistry, University of Health Sciences
Keçiören, Ankara, 06010
Nurullah Yurdakul, 05340757662, yurdakul.nurullah@gmail.com
About this study
Official title: Evaluation of Bone Destruction and Oxidative Stress Markers in Saliva and Peri-implant Sulcus Fluid in Peri-implantitis
The aim of this study is to evaluate and compare the levels of bone resorption (RANKL, OPG) and oxidative stress (Nitrotyrosine, NQO1) markers, along with pro-inflammatory cytokines (IL-1β), in the saliva and peri-implant sulcular fluid (PISF) of patients with peri-implantitis, periodontitis, and healthy individuals. The study seeks to determine the diagnostic value of these biomarkers in the early detection and progression of peri-implant diseases.
Read the detailed description
Patients applying to the University of Health Sciences, Gulhane Faculty of Dentistry, Department of Periodontology, will be screened according to the inclusion and exclusion criteria. Following clinical and radiographic examinations, participants will be categorized into four groups (n=20 per group): Periodontitis, Peri-implantitis, Periodontal Health, and Peri-implant Health. All clinical parameters, including Plaque Index (PI), Gingival Index (GI), Bleeding on Probing (BOP), Probing Depth (PD), and Clinical Attachment Loss (CAL), will be recorded at six sites per tooth/implant using a Williams periodontal probe.
The biological sample collection protocol will be conducted as follows:
Saliva Collection: To minimize circadian rhythm variations, unstimulated whole saliva samples (3 ml) will be collected between 9:00 AM and 10:00 AM. Patients will be instructed to refrain from eating, drinking, or oral hygiene procedures for at least one hour prior to collection. Samples will be centrifuged at 1,000g for 10 minutes to remove cellular debris, and the supernatant will be stored at -80°C until laboratory analysis.
Peri-implant Sulcular Fluid (PISF) and Gingival Crevicular Fluid (GCF) Collection: Samples will be obtained from the site with the deepest probing depth in each participant. The area will be isolated with cotton rolls and gently dried with an air syringe to prevent salivary contamination. Periopaper strips will be inserted into the sulcus/pocket for 30 seconds. Strips contaminated with blood or visible saliva will be discarded.
Laboratory Analysis: The concentrations of Interleukin-1 beta (IL-1β), Nitrotyrosine, Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL), Osteoprotegerin (OPG), and NAD(P)H: Quinone Oxidoreductase 1 (NQO1) will be quantified in both saliva and PISF/GCF samples using commercially available Enzyme-Linked Immunosorbent Assay (ELISA) kits according to the manufacturer's instructions.
- Conditions
- Periodontal Diseases, Periimplant Diseases
- Keywords
- Periodontal Diseases, periimplant diseases, Oxidative Stress, Alveolar Bone Loss
- Medical subject headings
- Periodontal Diseases, Alveolar Bone Loss
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 |
|---|---|---|
| Peri-implantitis Group | Patients with at least one dental implant in function for at least 1 year, showing signs of inflammation (BOP/suppuration), probing depth (PD) ≥ 5 mm, and radiographic bone loss ≥ 2 mm. | |
| Periodontitis Group | Patients with at least one tooth having clinical probing depth ≥ 4 mm, presence of bleeding on probing (BOP), and evidence of radiographic alveolar bone loss. | |
| Peri-implant Health Group | Patients with implants in function for at least 1 year, showing no signs of inflammation (no BOP), probing depth ≤ 3 mm, and no radiographic bone loss. | |
| Periodontal Health Group | Systemically healthy individuals with clinical probing depths ≤ 3 mm, minimal plaque and bleeding scores, and no radiographic evidence of bone loss. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary and Peri-implant Sulcular Fluid (PISF) IL-1β Levels.
The concentration of Interleukin-1 beta (IL-1β), a pro-inflammatory cytokine, will be measured in picograms per milliliter (pg/mL) using ELISA kits to evaluate the severity of inflammation and bone destruction.
Measured: At the baseline clinical examination (Day 0).
Secondary outcomes (6)
Salivary and Peri-implant Sulcular Fluid (PISF) Nitrotyrosine Levels
Concentration of Nitrotyrosine will be measured in saliva and PISF samples using ELISA kits. Nitrotyrosine serves as a biochemical marker of nitrosative stress to evaluate oxidative damage.
Measured: Baseline (at the time of clinical examination)
Salivary and Peri-implant Sulcular Fluid (PISF) NQO1 Levels
NAD(P)H: Quinone Oxidoreductase 1 (NQO1) levels will be measured using ELISA kits to assess the local and systemic antioxidant defense response.
Measured: Baseline (at the time of clinical examination)
Salivary and Peri-implant Sulcular Fluid (PISF) RANKL Levels
Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL) levels will be measured to evaluate osteoclast activation and bone destruction potential.
Measured: Baseline (at the time of clinical examination)
Salivary and Peri-implant Sulcular Fluid (PISF) OPG Levels
Osteoprotegerin (OPG) levels will be measured. OPG acts as a decoy receptor for RANKL, and its level indicates the body's attempt to inhibit bone resorption.
Measured: Baseline (at the time of clinical examination)
Clinical Attachment Loss (CAL) and Probing Depth (PD)
CAL and PD will be measured in millimeters (mm) at six sites per tooth/implant using a Williams periodontal probe to assess the severity of tissue destruction.
Measured: Baseline (at the time of clinical examination)
Plaque Index (PI) and Gingival Index (GI)
PI and GI will be recorded using Silness-Löe and Löe-Silness indices (scored 0-3) to evaluate oral hygiene status and gingival inflammation.
Measured: Baseline (at the time of clinical examination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start15 Feb 2026
- Primary completion15 Nov 2026 (estimated)
- Study completion20 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülbahar Ustaoğlu, Saglik Bilimleri Universitesi
- Investigators
- Gülbahar Ustaoğlu, Professor, Principal investigator, University of Health Sciences, Gulhane Faculty of Dentistry, Department of Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07397884
- Sponsor's protocol ID
- 2025-403
- Status last verified
- Jan 2026
- First submitted
- 2 Feb 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data will not be shared to protect participant privacy.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bone Destruction and Oxidative Stress Markers in Saliva and Peri-implant Sulcus Fluid in Peri-implantitis
- ClinicalTrials.gov ID
- NCT07397884
- Acronym / sponsor ID
- 2025-403
- Conditions
- Periodontal Diseases, Periimplant Diseases
- Keywords
- Periodontal Diseases, periimplant diseases, Oxidative Stress, Alveolar Bone Loss
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 15 Feb 2026 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 20 Nov 2026 (estimated)
- First posted
- 9 Feb 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.
The aim of this study is to evaluate and compare the levels of bone resorption (RANKL, OPG) and oxidative stress (Nitrotyrosine, NQO1) markers, along with pro-inflammatory cytokines (IL-1β), in the saliva and peri-implant sulcular fluid (PISF) of patients with peri-implantitis, periodontitis, and healthy individuals. The study seeks to determine the diagnostic value of these biomarkers in the early detection and progression of peri-implant diseases.
Detailed description
Patients applying to the University of Health Sciences, Gulhane Faculty of Dentistry, Department of Periodontology, will be screened according to the inclusion and exclusion criteria. Following clinical and radiographic examinations, participants will be categorized into four groups (n=20 per group): Periodontitis, Peri-implantitis, Periodontal Health, and Peri-implant Health. All clinical parameters, including Plaque Index (PI), Gingival Index (GI), Bleeding on Probing (BOP), Probing Depth (PD), and Clinical Attachment Loss (CAL), will be recorded at six sites per tooth/implant using a Williams periodontal probe.
The biological sample collection protocol will be conducted as follows:
Saliva Collection: To minimize circadian rhythm variations, unstimulated whole saliva samples (3 ml) will be collected between 9:00 AM and 10:00 AM. Patients will be instructed to refrain from eating, drinking, or oral hygiene procedures for at least one hour prior to collection. Samples will be centrifuged at 1,000g for 10 minutes to remove cellular debris, and the supernatant will be stored at -80°C until laboratory analysis.
Peri-implant Sulcular Fluid (PISF) and Gingival Crevicular Fluid (GCF) Collection: Samples will be obtained from the site with the deepest probing depth in each participant. The area will be isolated with cotton rolls and gently dried with an air syringe to prevent salivary contamination. Periopaper strips will be inserted into the sulcus/pocket for 30 seconds. Strips contaminated with blood or visible saliva will be discarded.
Laboratory Analysis: The concentrations of Interleukin-1 beta (IL-1β), Nitrotyrosine, Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL), Osteoprotegerin (OPG), and NAD(P)H: Quinone Oxidoreductase 1 (NQO1) will be quantified in both saliva and PISF/GCF samples using commercially available Enzyme-Linked Immunosorbent Assay (ELISA) kits according to the manufacturer's instructions.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Peri-implantitis Group | – | –Patients with at least one dental implant in function for at least 1 year, showing signs of inflammation (BOP/suppuration), probing depth (PD) ≥ 5 mm, and radiographic bone loss ≥ 2 mm. |
| Periodontitis Group | – | –Patients with at least one tooth having clinical probing depth ≥ 4 mm, presence of bleeding on probing (BOP), and evidence of radiographic alveolar bone loss. |
| Peri-implant Health Group | – | –Patients with implants in function for at least 1 year, showing no signs of inflammation (no BOP), probing depth ≤ 3 mm, and no radiographic bone loss. |
| Periodontal Health Group | – | –Systemically healthy individuals with clinical probing depths ≤ 3 mm, minimal plaque and bleeding scores, and no radiographic evidence of bone loss. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who apply to the University of Health Sciences, Gulhane Faculty of Dentistry, Department of Periodontology, and meet the specific clinical and radiographic criteria for peri-implantitis, periodontitis, or health.
Key inclusion criteria (11 listed)
- Systemically healthy volunteers aged 18-65. For Peri-implantitis group: Implants in function for ≥1 year, radiographic bone loss ≥ 2 mm, probing depth (PD) ≥ 5 mm, and presence of bleeding on probing (BOP) or suppuration.
- For Periodontitis group: At least one tooth with PD ≥ 4 mm, presence of BOP, and radiographic bone loss.For Healthy groups: PD ≤ 3 mm, no clinical inflammation (BOP-), and no radiographic bone loss.
- (According to the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases) -
- Exclusion Criteria:Presence of systemic diseases (e.g., diabetes, rheumatoid arthritis, osteoporosis).
- Use of antibiotics, anti-inflammatory, or immunosuppressive drugs within the last 3 months.
Key exclusion criteria (0 listed)
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
Salivary and Peri-implant Sulcular Fluid (PISF) IL-1β Levels.
Time frame: At the baseline clinical examination (Day 0).
The concentration of Interleukin-1 beta (IL-1β), a pro-inflammatory cytokine, will be measured in picograms per milliliter (pg/mL) using ELISA kits to evaluate the severity of inflammation and bone destruction.
6 secondary outcomes
Salivary and Peri-implant Sulcular Fluid (PISF) Nitrotyrosine Levels
Time frame: Baseline (at the time of clinical examination)
Salivary and Peri-implant Sulcular Fluid (PISF) NQO1 Levels
Time frame: Baseline (at the time of clinical examination)
Salivary and Peri-implant Sulcular Fluid (PISF) RANKL Levels
Time frame: Baseline (at the time of clinical examination)
Salivary and Peri-implant Sulcular Fluid (PISF) OPG Levels
Time frame: Baseline (at the time of clinical examination)
Clinical Attachment Loss (CAL) and Probing Depth (PD)
Time frame: Baseline (at the time of clinical examination)
Plaque Index (PI) and Gingival Index (GI)
Time frame: Baseline (at the time of clinical examination)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No. The individual participant data will not be shared to protect participant privacy.
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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.
Gülbahar Ustaoğlu, Professor principal investigator
University of Health Sciences, Gulhane Faculty of Dentistry, Department of Periodontology
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 Periodontal Diseases and Periimplant Diseases, run by Saglik Bilimleri Universitesi 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 11 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 29 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nurullah Yurdakul, Dr. (+905340757662, nurullah.yurdakul@sbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary and Peri-implant Sulcular Fluid (PISF) IL-1β Levels. (time frame: At the baseline clinical examination (Day 0).). 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 29 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.