Boron Levels, Oxidative Stress, and Inflammation in Periodontitis
16 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Estimé)
60
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: LEYLA KURU
- Numéro de téléphone: +905363791443
- E-mail: lkuru@marmara.edu.tr
Lieux d'étude
-
-
Maltepe
-
Istanbul, Maltepe, Turquie (Türkiye), 34854
- Recrutement
- : Department of Periodontology, Faculty of Dentistry, Marmara University, Istanbul,
-
Contact:
- ECMEL BERİL ÖNER
- Numéro de téléphone: +905399734949
- E-mail: beril_yusuf@hotmail.com
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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.
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Boron Levels in Saliva and Gingival Tissue
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Oxidative Stress Markers
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
26 février 2026
Achèvement primaire (Estimé)
1 novembre 2026
Achèvement de l'étude (Estimé)
1 mars 2027
Dates d'inscription aux études
Première soumission
16 août 2026
Première soumission répondant aux critères de contrôle qualité
16 août 2026
Première publication (Réel)
20 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
20 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
16 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2026-9
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime 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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .