Boron Levels, Oxidative Stress, and Inflammation in Periodontitis
16 de agosto de 2026 atualizado por: 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.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Descrição detalhada
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 de estudo
Observacional
Inscrição (Estimado)
60
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: LEYLA KURU
- Número de telefone: +905363791443
- E-mail: lkuru@marmara.edu.tr
Locais de estudo
-
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Maltepe
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Istanbul, Maltepe, Turquia (Türkiye), 34854
- Recrutamento
- : Department of Periodontology, Faculty of Dentistry, Marmara University, Istanbul,
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Contato:
- ECMEL BERİL ÖNER
- Número de telefone: +905399734949
- E-mail: beril_yusuf@hotmail.com
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Método de amostragem
Amostra Não Probabilística
População do estudo
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.
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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.
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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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Boron Levels in Saliva and Gingival Tissue
Prazo: 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.
|
At the time of the clinically indicated periodontal surgical procedure
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Oxidative Stress Markers
Prazo: 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
|
|
Antioxidant Defense Markers
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
26 de fevereiro de 2026
Conclusão Primária (Estimado)
1 de novembro de 2026
Conclusão do estudo (Estimado)
1 de março de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
16 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
16 de agosto de 2026
Primeira postagem (Real)
20 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
20 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
16 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2026-9
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano 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.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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