PeriodontitisNCT07775378
Boron Levels, Oxidative Stress, and Inflammation in Periodontitis
An observational study of Periodontitis, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This cross-sectional observational study aims to evaluate the relationship between boron levels and oxidative stress, antioxidant defense, and inflammatory markers in individuals with periodontitis. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Biochemical Assessment of Saliva and Gingival Tissue
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Feb 2026to Mar 2027
- 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: The study population will consist of 60 systemically healthy individuals aged 18-65 years attending the Department of Periodontology, Faculty of Dentistry, Marmara University. Participants will be divided into two groups: 30 individuals with Stage III-IV periodontitis with an indication for periodontal flap surgery and 30 periodontally healthy individuals with an indication for crown-lengthening surgery.
Who may be able to join
- Volunteering to participate in the study and signing the informed consent form
- Being between 18 and 65 years of age
- Being systemically healthy
- No antibiotic use within the last 3 months
- No periodontal treatment within the last 6 months
- Being a non-smoker or having quit smoking at least 5 years ago
Show all 12Show fewer
- Not being pregnant or breastfeeding
- No current use of steroids, immunosuppressive drugs, or non-steroidal anti-inflammatory drugs
- No current use of medications associated with gingival enlargement, such as calcium channel blockers, phenytoin, or cyclosporine
- No regular use of boron-containing supplements or multivitamin complexes
- For the periodontally healthy group: no clinical attachment loss, bleeding on probing <10%, probing depth ≤3 mm, no radiographic bone loss, and an indication for crown-lengthening surgery
- For the periodontitis group: diagnosis of Stage III or IV periodontitis according to the 2017 World Workshop classification and an indication for periodontal flap surgery
Who cannot join
- Incomplete or unreliable clinical measurements
- Insufficient saliva or gingival tissue sample for biochemical analyses
- Regular use of boron-containing oral care products within the last 3 months
- Regular consumption of boron-rich supplements or mineral waters
- Failure to comply with the study protocol
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
: Department of Periodontology, Faculty of Dentistry, Marmara University, Istanbul,
Istanbul, Maltepe, 34854
ECMEL BERİL ÖNER, +905399734949, beril_yusuf@hotmail.com
About this study
Official title: Evaluation of the Relationship Between Boron Levels and Oxidative Stress, Antioxidant Defense, and Inflammatory Markers in Individuals With Periodontitis
This cross-sectional observational study aims to evaluate the relationship between boron levels and oxidative stress, antioxidant defense, and inflammatory markers in individuals with periodontitis. The study will include systemically healthy, non-smoking individuals divided into two groups: periodontally healthy controls and patients with Stage III-IV periodontitis. Boron levels and selected oxidative stress, antioxidant, and inflammatory biomarkers will be evaluated in saliva and gingival tissue samples. The findings will be compared between the groups to investigate the potential relationship between boron levels and periodontal inflammation and oxidative stress.
Read the detailed description
Periodontitis is a chronic inflammatory disease characterized by the destruction of the tooth-supporting tissues and is associated with an imbalance between oxidative stress and antioxidant defense mechanisms. Boron is a trace element that has been suggested to have potential roles in antioxidant and inflammatory processes; however, its relationship with periodontal disease remains unclear.
This cross-sectional observational study will include 60 systemically healthy, non-smoking participants: 30 periodontally healthy individuals and 30 patients diagnosed with Stage III-IV periodontitis. Periodontal clinical parameters will be recorded for all participants.
Unstimulated saliva samples will be collected before periodontal surgical procedures. Gingival tissue samples will be obtained during clinically indicated periodontal surgical procedures, including crown-lengthening procedures in periodontally healthy participants and periodontal surgery in participants with periodontitis.
Boron levels will be determined in saliva and gingival tissue samples. Oxidative stress and antioxidant defense will be evaluated using selected biomarkers, including reactive oxygen species, total oxidant status, malondialdehyde, total antioxidant status, glutathione, superoxide dismutase, and catalase. Interleukin-1 beta will be evaluated as an inflammatory marker.
Boron levels and biochemical parameters will be compared between periodontally healthy individuals and participants with periodontitis, and their relationships with periodontal clinical parameters, oxidative stress, antioxidant defense, and inflammation will be investigated.
- Conditions
- Periodontitis
- Being tested
- Biochemical Assessment of Saliva and Gingival Tissue
- Keywords
- Boron, Oxidative Stress, Antioxidant Defense, Inflammation, Saliva, Gingival Tissue
- Medical subject headings
- Periodontitis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biochemical Assessment of Saliva and Gingival TissueOther
Unstimulated saliva and gingival tissue samples will be collected from participants. Gingival tissue samples will be obtained during clinically indicated periodontal surgical procedures. The samples will be biochemically analyzed to determine boron levels and markers of oxidative stress, antioxidant defense, and inflammation. No experimental treatment or therapeutic intervention will be administered as part of the study.
| Study group | Role | What they receive |
|---|---|---|
| Periodontitis Group | Systemically healthy, non-smoking individuals diagnosed with Stage III-IV periodontitis who are scheduled for clinically indicated periodontal surgical treatment. Receives: Other: Biochemical Assessment of Saliva and Gingival Tissue | |
| Periodontally Healthy Group | Systemically healthy, non-smoking individuals with periodontal health who are scheduled for clinically indicated crown-lengthening surgery. Receives: Other: Biochemical Assessment of Saliva and Gingival Tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boron Levels in Saliva and Gingival Tissue
Boron levels will be measured in unstimulated saliva and gingival tissue samples obtained from participants in the periodontitis and periodontally healthy groups. Salivary boron levels will be expressed as µg/mL and gingival tissue boron levels as µg/g.
Measured: At the time of the clinically indicated periodontal surgical procedure
Secondary outcomes (3)
Oxidative Stress Markers
Oxidative stress will be assessed by measuring reactive oxygen species (ROS), total oxidant status (TOS), and malondialdehyde (MDA) levels in samples obtained from the periodontitis and periodontally healthy groups.
Measured: At the time of the clinically indicated periodontal surgical procedure
Antioxidant Defense Markers
Antioxidant defense will be assessed by measuring total antioxidant status (TAS), glutathione (GSH), superoxide dismutase (SOD), and catalase (CAT) levels in samples obtained from the periodontitis and periodontally healthy groups.
Measured: At the time of the clinically indicated periodontal surgical procedure
Inflammatory Marker
Inflammation will be assessed by measuring interleukin-1 beta (IL-1β) levels in samples obtained from the periodontitis and periodontally healthy groups.
Measured: At the time of the clinically indicated periodontal surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start26 Feb 2026
- Primary completionNov 2026 (estimated)
- Study completionMar 2027 (estimated)
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 Marmara 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07775378
- Sponsor's protocol ID
- 2026-9
- Status last verified
- Aug 2026
- First submitted
- 16 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared, as data sharing beyond the scope of the present study was not included in the approved study protocol and informed consent process.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Boron Levels and Oxidative Stress, Antioxidant Defense, and Inflammatory Markers in Individuals With Periodontitis
- ClinicalTrials.gov ID
- NCT07775378
- Acronym / sponsor ID
- 2026-9
- Conditions
- Periodontitis
- Keywords
- Boron, Oxidative Stress, Antioxidant Defense, Inflammation, Saliva, Gingival Tissue
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 26 Feb 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 20 Aug 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 boron levels and oxidative stress, antioxidant defense, and inflammatory markers in individuals with periodontitis. The study will include systemically healthy, non-smoking individuals divided into two groups: periodontally healthy controls and patients with Stage III-IV periodontitis. Boron levels and selected oxidative stress, antioxidant, and inflammatory biomarkers will be evaluated in saliva and gingival tissue samples. The findings will be compared between the groups to investigate the potential relationship between boron levels and periodontal inflammation and oxidative stress.
Detailed description
Periodontitis is a chronic inflammatory disease characterized by the destruction of the tooth-supporting tissues and is associated with an imbalance between oxidative stress and antioxidant defense mechanisms. Boron is a trace element that has been suggested to have potential roles in antioxidant and inflammatory processes; however, its relationship with periodontal disease remains unclear.
This cross-sectional observational study will include 60 systemically healthy, non-smoking participants: 30 periodontally healthy individuals and 30 patients diagnosed with Stage III-IV periodontitis. Periodontal clinical parameters will be recorded for all participants.
Unstimulated saliva samples will be collected before periodontal surgical procedures. Gingival tissue samples will be obtained during clinically indicated periodontal surgical procedures, including crown-lengthening procedures in periodontally healthy participants and periodontal surgery in participants with periodontitis.
Boron levels will be determined in saliva and gingival tissue samples. Oxidative stress and antioxidant defense will be evaluated using selected biomarkers, including reactive oxygen species, total oxidant status, malondialdehyde, total antioxidant status, glutathione, superoxide dismutase, and catalase. Interleukin-1 beta will be evaluated as an inflammatory marker.
Boron levels and biochemical parameters will be compared between periodontally healthy individuals and participants with periodontitis, and their relationships with periodontal clinical parameters, oxidative stress, antioxidant defense, and inflammation will be investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periodontitis Group | – | Other: Biochemical Assessment of Saliva and Gingival TissueSystemically healthy, non-smoking individuals diagnosed with Stage III-IV periodontitis who are scheduled for clinically indicated periodontal surgical treatment. |
| Periodontally Healthy Group | – | Other: Biochemical Assessment of Saliva and Gingival TissueSystemically healthy, non-smoking individuals with periodontal health who are scheduled for clinically indicated crown-lengthening surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of 60 systemically healthy individuals aged 18-65 years attending the Department of Periodontology, Faculty of Dentistry, Marmara University. Participants will be divided into two groups: 30 individuals with Stage III-IV periodontitis with an indication for periodontal flap surgery and 30 periodontally healthy individuals with an indication for crown-lengthening surgery.
Key inclusion criteria (12 listed)
- Volunteering to participate in the study and signing the informed consent form
- Being between 18 and 65 years of age
- Being systemically healthy
- No antibiotic use within the last 3 months
- No periodontal treatment within the last 6 months
Key exclusion criteria (5 listed)
- Incomplete or unreliable clinical measurements
- Insufficient saliva or gingival tissue sample for biochemical analyses
- Regular use of boron-containing oral care products within the last 3 months
- Regular consumption of boron-rich supplements or mineral waters
- Failure to comply with the study protocol
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 |
|---|---|---|
| Biochemical Assessment of Saliva and Gingival TissueUnstimulated saliva and gingival tissue samples will be collected from participants. Gingival tissue samples will be obtained during clinically indicated periodontal surgical procedures. The samples will be biochemically analyzed to determine boron levels and markers of oxidative stress, antioxidant defense, and inflammation. No experimental treatment or therapeutic intervention will be administered as part of the study. | Other | Periodontally Healthy Group, Periodontitis Group |
Primary outcome
Boron Levels in Saliva and Gingival Tissue
Time frame: At the time of the clinically indicated periodontal surgical procedure
Boron levels will be measured in unstimulated saliva and gingival tissue samples obtained from participants in the periodontitis and periodontally healthy groups. Salivary boron levels will be expressed as µg/mL and gingival tissue boron levels as µg/g.
3 secondary outcomes
Oxidative Stress Markers
Time frame: At the time of the clinically indicated periodontal surgical procedure
Antioxidant Defense Markers
Time frame: At the time of the clinically indicated periodontal surgical procedure
Inflammatory Marker
Time frame: At the time of the clinically indicated periodontal surgical procedure
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 20 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared, as data sharing beyond the scope of the present study was not included in the approved study protocol and informed consent process.
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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.
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, run by Marmara 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 12 inclusion and 5 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 20 Aug 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 LEYLA KURU (+905363791443, lkuru@marmara.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boron Levels in Saliva and Gingival Tissue (time frame: At the time of the clinically indicated periodontal surgical procedure). 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 20 Aug 2026.