Boron Levels, Oxidative Stress, and Inflammation in Periodontitis
16. August 2026 aktualisiert von: Marmara University
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.
Studienübersicht
Status
Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Geschätzt)
60
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: LEYLA KURU
- Telefonnummer: +905363791443
- E-Mail: lkuru@marmara.edu.tr
Studienorte
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Maltepe
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Istanbul, Maltepe, Türkei (türkiye), 34854
- Rekrutierung
- : Department of Periodontology, Faculty of Dentistry, Marmara University, Istanbul,
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Kontakt:
- ECMEL BERİL ÖNER
- Telefonnummer: +905399734949
- E-Mail: beril_yusuf@hotmail.com
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Ja
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
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.
Beschreibung
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
Periodontitis Group
Systemically healthy, non-smoking individuals diagnosed with Stage III-IV periodontitis who are scheduled for clinically indicated periodontal surgical treatment.
|
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.
|
|
Periodontally Healthy Group
Systemically healthy, non-smoking individuals with periodontal health who are scheduled for clinically indicated crown-lengthening surgery.
|
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Boron Levels in Saliva and Gingival Tissue
Zeitfenster: At the time of the clinically indicated periodontal surgical procedure
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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.
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At the time of the clinically indicated periodontal surgical procedure
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Oxidative Stress Markers
Zeitfenster: At the time of the clinically indicated periodontal surgical procedure
|
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.
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At the time of the clinically indicated periodontal surgical procedure
|
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Antioxidant Defense Markers
Zeitfenster: At the time of the clinically indicated periodontal surgical procedure
|
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.
|
At the time of the clinically indicated periodontal surgical procedure
|
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Inflammatory Marker
Zeitfenster: At the time of the clinically indicated periodontal surgical procedure
|
Inflammation will be assessed by measuring interleukin-1 beta (IL-1β) levels in samples obtained from the periodontitis and periodontally healthy groups.
|
At the time of the clinically indicated periodontal surgical procedure
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
26. Februar 2026
Primärer Abschluss (Geschätzt)
1. November 2026
Studienabschluss (Geschätzt)
1. März 2027
Studienanmeldedaten
Zuerst eingereicht
16. August 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
16. August 2026
Zuerst gepostet (Tatsächlich)
20. August 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
20. August 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
16. August 2026
Zuletzt verifiziert
1. August 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2026-9
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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