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Boron Levels, Oxidative Stress, and Inflammation in Periodontitis

16 agosto 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

60

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Turchia (Türkiye)
    • Maltepe
      • Istanbul, Maltepe, Turchia (Türkiye), 34854
        • Reclutamento
        • : Department of Periodontology, Faculty of Dentistry, Marmara University, Istanbul,
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Periodontitis Group
Systemically healthy, non-smoking individuals diagnosed with Stage III-IV periodontitis who are scheduled for clinically indicated periodontal surgical treatment.
Altro: Biochemical Assessment of Saliva and Gingival Tissue
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.
Altro: Biochemical Assessment of Saliva and Gingival Tissue
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Boron Levels in Saliva and Gingival Tissue
Lasso di tempo: 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.
At the time of the clinically indicated periodontal surgical procedure

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Oxidative Stress Markers
Lasso di tempo: 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.
At the time of the clinically indicated periodontal surgical procedure
Antioxidant Defense Markers
Lasso di tempo: 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
Inflammatory Marker
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Marmara University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

26 febbraio 2026

Completamento primario (Stimato)

1 novembre 2026

Completamento dello studio (Stimato)

1 marzo 2027

Date di iscrizione allo studio

Primo inviato

16 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

16 agosto 2026

Primo Inserito (Effettivo)

20 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

20 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2026-9

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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