Periodontal HealthNCT06986044
EVALUATION OF SALIVA AND SERUM HEME OXYGENASE, ARYLESTERASE AND NUCLEAR FACTOR ERYTHROID 2-RELATED FACTOR 2 LEVELS IN PATIENTS WITH STAGE III PERIODONTITIS
An observational study of Periodontal Health and Periodontitis Stage III, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Periodontal disease is a chronic and progressive inflammatory disease in which the hard and soft tissues that support the teeth are damaged. It is caused by the interaction between harmful bacteria and the body's immune responses, and most periodontal tissues are damaged by the body's abnormal response to these… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Health, Periodontitis Stage III
- What is being tested?
- Serum Total Oxidant Status, Salivary Total Oxidant Status and Serum Total Antioxidant Status
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 15 Sep 2024
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: periodontally healthy 19 female and 18 male subjects with a mean age of 39.48 years. periodontitis state III individuals, 20 females and 17 males with a mean age of 39.05 years.
Who may be able to join
- systemically healthy
- between the ages of 18-65
Who cannot join
- Patients with systemic diseases and/or conditions that may affect periodontal tissues (cardiovascular diseases, immune system diseases, rheumatoid arthritis, diabetes mellitus, chemotherapy/radiotherapy).
- taking any medication that may have an effect on periodontal tissues,
- less than 20 natural teeth excluding third molars
- used antibiotics, anti-inflammatory or immunosuppressive drugs
- periodontal treatment in the last 6 months
- smokers
- pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi
Ankara, Keçiören, 06010
About this study
Periodontal disease is a chronic and progressive inflammatory disease in which the hard and soft tissues that support the teeth are damaged. It is caused by the interaction between harmful bacteria and the body's immune responses, and most periodontal tissues are damaged by the body's abnormal response to these microorganisms and their products. When bacteria enter the body, immune cells (neutrophils) produce reactive oxygen species (ROS) in a process called the "respiratory burst". These ROS damage cells, causing tissue destruction through a variety of mechanisms, including DNA damage, fat oxidation and protein damage. Studies have shown that neutrophils from individuals with periodontal disease produce more ROS than neutrophils from healthy individuals. High amounts of ROS lead to oxidative damage to gum tissue, periodontal ligament and alveolar bone. Oxidative stress occurs when antioxidants in the body are insufficient or when high levels of ROS are present. Therefore, disruption of the balance between oxidant and antioxidant activities is considered an important cause of oxidative damage in periodontal tissues. Parameters such as total antioxidant status (TAS), total oxidant status (TOS) and oxidative stress index (OSI) are used to determine oxidative stress.
Furthermore, some enzymes such as arylesterase (ARE), heme oxygenase (HO) and nuclear factor erythroid 2-related factor 2 (NRF-2) are involved in defense mechanisms against oxidative stress. Many recent studies have shown a strong association between oxidative stress and periodontal disease.
Read the detailed description
This study was divided into 2 groups, 37 systemically and periodontally health individuals and 37 systemically healthy individuals with stage III grade B periodontitis were included. Clinical periodontal parameters plaque index (PI), gingival index (GI), probing pocket depth (SCD), bleeding on probing (BOP) and clinical attachment level (CAL) were recorded and saliva and serum samples were collected. ELISA method was used for analyses of TOS, TAS, OSI, ARE, HO-1, NRF-2 levels.
- Conditions
- Periodontal Health, Periodontitis Stage III
- Being tested
- Serum Total Oxidant Status, Salivary Total Oxidant Status, Serum Total Antioxidant Status, Salivary Total Antioxidant Status, Serum Oxidative Stress Index
- Keywords
- total antioxidan status, total oxidan status, oxidative stress index, arylesterase, heme oxygenase, nuclear factor erythroid 2 related factor 2, saliva, serum, stage III periodontitis
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum Total Oxidant StatusDiagnostic test
Serum total oxidant status
Salivary Total Oxidant StatusDiagnostic test
Salivary Total Oxidant Status
Serum Total Antioxidant StatusDiagnostic test
Serum Total Antioxidant Status
Salivary Total Antioxidant StatusDiagnostic test
Salivary Total Antioxidant Status
Serum Oxidative Stress IndexDiagnostic test
Serum Oxidative Stress Index
Salivary Oxidative Stress IndexDiagnostic test
Salivary Oxidative Stress Index
Serum ArylesteraseDiagnostic test
Serum Arylesterase
Salivary ArylesteraseDiagnostic test
Salivary Arylesterase
Serum Heme OxygenaseDiagnostic test
Serum Heme Oxygenase
Salivary Heme OxygenaseDiagnostic test
Salivary Heme Oxygenase
Serum Nuclear Factor Erythroid 2 Related Factor 2Diagnostic test
Serum Nuclear Factor Erythroid 2 Related Factor 2
Salivary Nuclear Factor Erythroid 2 Related Factor 2Diagnostic test
Salivary Nuclear Factor Erythroid 2 Related Factor 2
Gingival IndexDiagnostic test
Gingival Index
Plaque IndexDiagnostic test
Plaque Index
Bleeding on Probing IndexDiagnostic test
Bleeding on Probing Index
Clinical Attachment LossDiagnostic test
Clinical Attachment Loss
Pocket DeepDiagnostic test
Pocket Deep
| Study group | Role | What they receive |
|---|---|---|
| stage III grade B periodontitis | Pocket deep ≤ 6 mm, clinical attachment loss ≥ 5 mm, tooth loss related to periodontitis ≤ 4, radiographic bone loss/age between 0.25-1 and periodontal tissue destruction compatible with biofilm accumulation. Receives: Diagnostic Test: Serum Total Oxidant Status; Diagnostic Test: Salivary Total Oxidant Status; Diagnostic Test: Serum Total Antioxidant Status; Diagnostic Test: Salivary Total Antioxidant Status; Diagnostic Test: Serum Oxidative Stress Index; Diagnostic Test: Salivary Oxidative Stress Index; Diagnostic Test: Serum Arylesterase; Diagnostic Test: Salivary Arylesterase; Diagnostic Test: Serum Heme Oxygenase; Diagnostic Test: Salivary Heme Oxygenase; Diagnostic Test: Serum Nuclear Factor Erythroid 2 Related Factor 2; Diagnostic Test: Salivary Nuclear Factor Erythroid 2 Related Factor 2; Diagnostic Test: Gingival Index; Diagnostic Test: Plaque Index; Diagnostic Test: Bleeding on Probing Index; Diagnostic Test: Clinical Attachment Loss; Diagnostic Test: Pocket Deep | |
| periodontally health | Pocket deep ≤ 3 mm, bleeding on probing index ≤ %10 and gingival index ≤ 1 Receives: Diagnostic Test: Serum Total Oxidant Status; Diagnostic Test: Salivary Total Oxidant Status; Diagnostic Test: Serum Total Antioxidant Status; Diagnostic Test: Salivary Total Antioxidant Status; Diagnostic Test: Serum Oxidative Stress Index; Diagnostic Test: Salivary Oxidative Stress Index; Diagnostic Test: Serum Arylesterase; Diagnostic Test: Salivary Arylesterase; Diagnostic Test: Serum Heme Oxygenase; Diagnostic Test: Salivary Heme Oxygenase; Diagnostic Test: Serum Nuclear Factor Erythroid 2 Related Factor 2; Diagnostic Test: Salivary Nuclear Factor Erythroid 2 Related Factor 2; Diagnostic Test: Gingival Index; Diagnostic Test: Plaque Index; Diagnostic Test: Bleeding on Probing Index; Diagnostic Test: Clinical Attachment Loss; Diagnostic Test: Pocket Deep |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum and saliva TAS (mmol Trolox Eq/L) levels
TAS concentrations were evaluated utilizing an innovative automated colorimetric assay, originally developed by Erel. The outcomes were reported as millimoles of Trolox equivalent per liter (mmol Trolox Eq/L).
Total antioxidant levels are significantly lower in periodontitis patients compared to healthy individuals, suggesting increased oxidative stress associated with periodontal inflammation.
Measured: 6 months
serum and saliva TOS (µmol H₂O₂ Eq/L) levels
TOS concentrations were determined through a distinct automated colorimetric technique, also described by Erel. Results were expressed as micromoles of hydrogen peroxide equivalent per liter (µmol H₂O₂ Eq/L). Compared to healthy controls, periodontitis patients show higher total oxidant levels, which may contribute to tissue destruction and disease progression.
Measured: 6 months
serum and saliva OSI levels
TAS values (initially in mmol Trolox Eq/L) were converted to µmol Trolox Eq/L. OSI was then computed using the following formula: OSI = [(TOS, µmol/L) / (TAS, µmol Trolox Eq/L)] × 100.
The oxidative stress index is significantly higher in periodontitis patients compared to healthy individuals, reflecting an imbalance between oxidants and antioxidants.
Measured: 6 months
serum and saliva ARE (U/L) levels
Arylesterase activity was assessed using commercially available assay kits (Rel Assay Diagnostics, Turkey). For the measurement of arylesterase activity, phenylacetate was used as the substrate. The enzymatic activity was calculated based on the molar extinction coefficient of the phenol formed (1,310 M-¹cm-¹). One unit of arylesterase activity was defined as the amount of enzyme required to hydrolyze 1 µmol of phenol per minute under the assay conditions and was also expressed as U/L. Arylesterase activity is significantly decreased in periodontitis patients compared to healthy controls, suggesting impaired antioxidant enzyme function.
Measured: 6 months
serum and saliva NRF-2 (ng/ml) levels
The level of NRF-2 was quantified using an enzyme-linked immunosorbent assay (ELISA) kit (BT lab.). In this assay, wells were pre-coated with human NRF-2-specific antibodies. Samples containing NRF2 were added to the wells, allowing target binding. Subsequently, a biotin-conjugated anti-NRF-2 antibody was applied, followed by streptavidin-horseradish peroxidase (HRP) conjugate. After washing to remove unbound components, a substrate solution was added, producing a colorimetric reaction proportional to the amount of NRF-2 present. The reaction was terminated by adding an acidic stop solution, and absorbance was measured at 450 nm. It is suggested that the reduced expression of NRF-2 in periodontitis patients, relative to healthy controls, contributes to increased oxidative stress and tissue damage.
Measured: 6 months
serum and saliva HO-1(ng/ml) levels
The concentration of HO-1 was measured using an ELISA kit (BT Lab.) Wells were pre-coated with human HO-1-specific antibodies. Following the addition of samples, human HO-1 proteins bound to the immobilized antibodies. A biotinylated anti-HO-1 antibody and subsequently streptavidin-HRP conjugate were introduced. After removal of unbound components via washing, a substrate solution was added to initiate color development, which was proportional to the HO-1 concentration. The reaction was stopped using an acidic solution, and absorbance was recorded at 450 nm. Compared to healthy subjects, HO-1 is considered to be less expressed in periodontitis patients, potentially compromising antioxidant and anti-inflammatory defenses
Measured: 6 months
Secondary outcomes (5)
Gingival Index (GI)
Gingival Index (GI) (Löe ve Silness) : The presence of gingival inflammation was determined on 4 surfaces of all teeth using the GI score defined by Löe and Silness. The periodontal probe was moved over the tooth and index values between 0-3 were determined for each tooth. Compared to healthy individuals, a high gingival index score is frequently observed in periodontitis patients, indicating greater gingival inflammation.
Measured: 6 months
Plaque Index (PI)
The presence of plaque and the Silness and Löe plaque index (PI) were obtained from 4 surfaces of the teeth after drying the teeth and index values between 0-3 were given. Plaque accumulation, as reflected by higher plaque index scores, is more prominent in periodontitis patients than in healthy controls.
Measured: 6 months
Bleeding on Probing Index (BoP)
Bleeding in probing was evaluated as (+) if there was bleeding in the relevant area within 30 seconds after applying pressure to the gingival sulcus with the periodontal probe in 4 regions of all teeth with the weight of the probe itself, and as (-) if there was no bleeding. Compared to healthy controls, periodontitis patients demonstrate a higher incidence of bleeding on probing, indicating active inflammation and compromised periodontal tissue integrity.
Measured: 6 months
Clinical Attachment Loss (CAL) (millimeter)
The distance between the cementoenamel junction of the tooth and the base of the periodontal pocket is calibrated millimetrically, with the clinical attachment level on 6 surfaces of all teeth. using a Williams periodontal probe. Clinical attachment level is significantly increased in periodontitis patients compared to healthy individuals, indicating the extent of periodontal tissue destruction.
Measured: 6 months
Pocket Depth (PD) (millimeter)
Probing pocket depth was performed on 6 surfaces of all teeth using a millimetrically calibrated Williams periodontal probe. The distance of the free gingival margin to the pocket bottom was measured in millimeters. The probe was held parallel to the long axis and the force applied to the probe was released when resistance was encountered during the measurement. Probing pocket depth is significantly greater in periodontitis patients compared to healthy individuals, reflecting deeper periodontal pockets due to tissue destruction.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start1 May 2023
- Primary completion1 May 2024
- Study completion15 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal HealthStudies 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
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Hazan YILDIZ, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06986044
- Sponsor's protocol ID
- GülhaneDiş
- Status last verified
- May 2025
- First submitted
- 22 Apr 2025
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF SALIVA AND SERUM HEME OXYGENASE, ARYLESTERASE AND NUCLEAR FACTOR ERYTHROID 2-RELATED FACTOR 2 LEVELS IN PATIENTS WITH STAGE III PERIODONTITIS
- ClinicalTrials.gov ID
- NCT06986044
- Acronym / sponsor ID
- GülhaneDiş
- Conditions
- Periodontal Health, Periodontitis Stage III
- Keywords
- total antioxidan status, total oxidan status, oxidative stress index, arylesterase, heme oxygenase, nuclear factor erythroid 2 related factor 2, saliva, serum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 22 May 2025 (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.
Periodontal disease is a chronic and progressive inflammatory disease in which the hard and soft tissues that support the teeth are damaged. It is caused by the interaction between harmful bacteria and the body's immune responses, and most periodontal tissues are damaged by the body's abnormal response to these microorganisms and their products. When bacteria enter the body, immune cells (neutrophils) produce reactive oxygen species (ROS) in a process called the "respiratory burst". These ROS damage cells, causing tissue destruction through a variety of mechanisms, including DNA damage, fat oxidation and protein damage. Studies have shown that neutrophils from individuals with periodontal disease produce more ROS than neutrophils from healthy individuals. High amounts of ROS lead to oxidative damage to gum tissue, periodontal ligament and alveolar bone. Oxidative stress occurs when antioxidants in the body are insufficient or when high levels of ROS are present. Therefore, disruption of the balance between oxidant and antioxidant activities is considered an important cause of oxidative damage in periodontal tissues. Parameters such as total antioxidant status (TAS), total oxidant status (TOS) and oxidative stress index (OSI) are used to determine oxidative stress.
Furthermore, some enzymes such as arylesterase (ARE), heme oxygenase (HO) and nuclear factor erythroid 2-related factor 2 (NRF-2) are involved in defense mechanisms against oxidative stress. Many recent studies have shown a strong association between oxidative stress and periodontal disease.
Detailed description
This study was divided into 2 groups, 37 systemically and periodontally health individuals and 37 systemically healthy individuals with stage III grade B periodontitis were included. Clinical periodontal parameters plaque index (PI), gingival index (GI), probing pocket depth (SCD), bleeding on probing (BOP) and clinical attachment level (CAL) were recorded and saliva and serum samples were collected. ELISA method was used for analyses of TOS, TAS, OSI, ARE, HO-1, NRF-2 levels.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stage III grade B periodontitis | – | Diagnostic Test: Serum Total Oxidant Status, Diagnostic Test: Salivary Total Oxidant Status, Diagnostic Test: Serum Total Antioxidant Status, Diagnostic Test: Salivary Total Antioxidant Status, Diagnostic Test: Serum Oxidative Stress Index, Diagnostic Test: Salivary Oxidative Stress Index, Diagnostic Test: Serum Arylesterase, Diagnostic Test: Salivary Arylesterase, Diagnostic Test: Serum Heme Oxygenase, Diagnostic Test: Salivary Heme Oxygenase, Diagnostic Test: Serum Nuclear Factor Erythroid 2 Related Factor 2, Diagnostic Test: Salivary Nuclear Factor Erythroid 2 Related Factor 2, Diagnostic Test: Gingival Index, Diagnostic Test: Plaque Index, Diagnostic Test: Bleeding on Probing Index, Diagnostic Test: Clinical Attachment Loss, Diagnostic Test: Pocket DeepPocket deep ≤ 6 mm, clinical attachment loss ≥ 5 mm, tooth loss related to periodontitis ≤ 4, radiographic bone loss/age between 0.25-1 and periodontal tissue destruction compatible with biofilm accumulation. |
| periodontally health | – | Diagnostic Test: Serum Total Oxidant Status, Diagnostic Test: Salivary Total Oxidant Status, Diagnostic Test: Serum Total Antioxidant Status, Diagnostic Test: Salivary Total Antioxidant Status, Diagnostic Test: Serum Oxidative Stress Index, Diagnostic Test: Salivary Oxidative Stress Index, Diagnostic Test: Serum Arylesterase, Diagnostic Test: Salivary Arylesterase, Diagnostic Test: Serum Heme Oxygenase, Diagnostic Test: Salivary Heme Oxygenase, Diagnostic Test: Serum Nuclear Factor Erythroid 2 Related Factor 2, Diagnostic Test: Salivary Nuclear Factor Erythroid 2 Related Factor 2, Diagnostic Test: Gingival Index, Diagnostic Test: Plaque Index, Diagnostic Test: Bleeding on Probing Index, Diagnostic Test: Clinical Attachment Loss, Diagnostic Test: Pocket DeepPocket deep ≤ 3 mm, bleeding on probing index ≤ %10 and gingival index ≤ 1 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- periodontally healthy 19 female and 18 male subjects with a mean age of 39.48 years. periodontitis state III individuals, 20 females and 17 males with a mean age of 39.05 years.
Key inclusion criteria (2 listed)
- systemically healthy
- between the ages of 18-65
Key exclusion criteria (7 listed)
- Patients with systemic diseases and/or conditions that may affect periodontal tissues (cardiovascular diseases, immune system diseases, rheumatoid arthritis, diabetes mellitus, chemotherapy/radiotherapy).
- taking any medication that may have an effect on periodontal tissues,
- less than 20 natural teeth excluding third molars
- used antibiotics, anti-inflammatory or immunosuppressive drugs
- periodontal treatment in the last 6 months
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 |
|---|---|---|
| Serum Total Oxidant StatusSerum total oxidant status | Diagnostic test | periodontally health, stage III grade B periodontitis |
| Salivary Total Oxidant StatusSalivary Total Oxidant Status | Diagnostic test | periodontally health, stage III grade B periodontitis |
| Serum Total Antioxidant StatusSerum Total Antioxidant Status | Diagnostic test | periodontally health, stage III grade B periodontitis |
| Salivary Total Antioxidant StatusSalivary Total Antioxidant Status | Diagnostic test | periodontally health, stage III grade B periodontitis |
| Serum Oxidative Stress IndexSerum Oxidative Stress Index | Diagnostic test | periodontally health, stage III grade B periodontitis |
| Salivary Oxidative Stress IndexSalivary Oxidative Stress Index | Diagnostic test | periodontally health, stage III grade B periodontitis |
| Serum ArylesteraseSerum Arylesterase | Diagnostic test | periodontally health, stage III grade B periodontitis |
| Salivary ArylesteraseSalivary Arylesterase | Diagnostic test | periodontally health, stage III grade B periodontitis |
| Serum Heme OxygenaseSerum Heme Oxygenase | Diagnostic test | periodontally health, stage III grade B periodontitis |
| Salivary Heme OxygenaseSalivary Heme Oxygenase | Diagnostic test | periodontally health, stage III grade B periodontitis |
| Serum Nuclear Factor Erythroid 2 Related Factor 2Serum Nuclear Factor Erythroid 2 Related Factor 2 | Diagnostic test | periodontally health, stage III grade B periodontitis |
| Salivary Nuclear Factor Erythroid 2 Related Factor 2Salivary Nuclear Factor Erythroid 2 Related Factor 2 | Diagnostic test | periodontally health, stage III grade B periodontitis |
| Gingival IndexGingival Index | Diagnostic test | periodontally health, stage III grade B periodontitis |
| Plaque IndexPlaque Index | Diagnostic test | periodontally health, stage III grade B periodontitis |
| Bleeding on Probing IndexBleeding on Probing Index | Diagnostic test | periodontally health, stage III grade B periodontitis |
| Clinical Attachment LossClinical Attachment Loss | Diagnostic test | periodontally health, stage III grade B periodontitis |
| Pocket DeepPocket Deep | Diagnostic test | periodontally health, stage III grade B periodontitis |
Primary outcome
serum and saliva TAS (mmol Trolox Eq/L) levels
Time frame: 6 months
TAS concentrations were evaluated utilizing an innovative automated colorimetric assay, originally developed by Erel. The outcomes were reported as millimoles of Trolox equivalent per liter (mmol Trolox Eq/L). Total antioxidant levels are significantly lower in periodontitis patients compared to healthy individuals, suggesting increased oxidative stress associated with periodontal inflammation.
serum and saliva TOS (µmol H₂O₂ Eq/L) levels
Time frame: 6 months
TOS concentrations were determined through a distinct automated colorimetric technique, also described by Erel. Results were expressed as micromoles of hydrogen peroxide equivalent per liter (µmol H₂O₂ Eq/L). Compared to healthy controls, periodontitis patients show higher total oxidant levels, which may contribute to tissue destruction and disease progression.
serum and saliva OSI levels
Time frame: 6 months
TAS values (initially in mmol Trolox Eq/L) were converted to µmol Trolox Eq/L. OSI was then computed using the following formula: OSI = [(TOS, µmol/L) / (TAS, µmol Trolox Eq/L)] × 100. The oxidative stress index is significantly higher in periodontitis patients compared to healthy individuals, reflecting an imbalance between oxidants and antioxidants.
serum and saliva ARE (U/L) levels
Time frame: 6 months
Arylesterase activity was assessed using commercially available assay kits (Rel Assay Diagnostics, Turkey). For the measurement of arylesterase activity, phenylacetate was used as the substrate. The enzymatic activity was calculated based on the molar extinction coefficient of the phenol formed (1,310 M-¹cm-¹). One unit of arylesterase activity was defined as the amount of enzyme required to hydrolyze 1 µmol of phenol per minute under the assay conditions and was also expressed as U/L. Arylesterase activity is significantly decreased in periodontitis patients compared to healthy controls, suggesting impaired antioxidant enzyme function.
serum and saliva NRF-2 (ng/ml) levels
Time frame: 6 months
The level of NRF-2 was quantified using an enzyme-linked immunosorbent assay (ELISA) kit (BT lab.). In this assay, wells were pre-coated with human NRF-2-specific antibodies. Samples containing NRF2 were added to the wells, allowing target binding. Subsequently, a biotin-conjugated anti-NRF-2 antibody was applied, followed by streptavidin-horseradish peroxidase (HRP) conjugate. After washing to remove unbound components, a substrate solution was added, producing a colorimetric reaction proportional to the amount of NRF-2 present. The reaction was terminated by adding an acidic stop solution, and absorbance was measured at 450 nm. It is suggested that the reduced expression of NRF-2 in periodontitis patients, relative to healthy controls, contributes to increased oxidative stress and tissue damage.
serum and saliva HO-1(ng/ml) levels
Time frame: 6 months
The concentration of HO-1 was measured using an ELISA kit (BT Lab.) Wells were pre-coated with human HO-1-specific antibodies. Following the addition of samples, human HO-1 proteins bound to the immobilized antibodies. A biotinylated anti-HO-1 antibody and subsequently streptavidin-HRP conjugate were introduced. After removal of unbound components via washing, a substrate solution was added to initiate color development, which was proportional to the HO-1 concentration. The reaction was stopped using an acidic solution, and absorbance was recorded at 450 nm. Compared to healthy subjects, HO-1 is considered to be less expressed in periodontitis patients, potentially compromising antioxidant and anti-inflammatory defenses
5 secondary outcomes
Gingival Index (GI)
Time frame: 6 months
Plaque Index (PI)
Time frame: 6 months
Bleeding on Probing Index (BoP)
Time frame: 6 months
Clinical Attachment Loss (CAL) (millimeter)
Time frame: 6 months
Pocket Depth (PD) (millimeter)
Time frame: 6 months
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 22 May 2025.
- Individual participant dataSharing planned: Undecided
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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 Periodontal Health and Periodontitis Stage III, 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 2 inclusion and 7 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 22 May 2025. 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?
serum and saliva TAS (mmol Trolox Eq/L) levels (time frame: 6 months). The study lists 6 primary outcomes in all. 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 22 May 2025.