- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07785817
Evaluation of aMMP-8 and IL-1β Levels and Marginal Bone Loss Associated With Peri-Implant Mucositis and Peri-Implantitis in Postmenopausal Women
Peri-implant mucositis and peri-implantitis are among the major biological complications threatening the long-term success of dental implants. Current diagnostic approaches are primarily based on clinical and radiographic assessments; however, there is still a need for reliable biomarkers that can detect biological alterations before extensive tissue destruction occurs. Hormonal changes associated with the postmenopausal period may influence bone metabolism and inflammatory responses, thereby increasing the susceptibility of peri-implant tissues to disease. Nevertheless, studies investigating local inflammatory biomarkers in peri-implant diseases among postmenopausal women remain limited.
Active matrix metalloproteinase-8 (aMMP-8) is a key enzyme involved in collagen degradation and connective tissue destruction and is considered one of the most important biomarkers of periodontal and peri-implant tissue breakdown. Interleukin-1 beta (IL-1β) is a potent pro-inflammatory cytokine associated with inflammatory responses, bone resorption, and tissue destruction. Assessment of these biomarkers in peri-implant crevicular fluid may contribute to the early diagnosis and risk assessment of peri-implant diseases.
The aim of this project is to evaluate the association between peri-implant health, peri-implant mucositis, peri-implantitis, and peri-implant crevicular fluid levels of aMMP-8 and IL-1β in postmenopausal women, together with clinical and radiographic parameters. Postmenopausal women with at least one functional dental implant will be recruited and classified into three groups according to their peri-implant status. Clinical peri-implant parameters will be recorded, standardized radiographic examinations will be performed, and peri-implant crevicular fluid samples will be collected using the PerioPaper method. Levels of aMMP-8 and IL-1β will be quantified using enzyme-linked immunosorbent assay (ELISA).
The obtained data will be analyzed using advanced statistical methods to investigate the relationships between biomarker levels and clinical and radiographic disease parameters. In addition, the diagnostic performance of aMMP-8 and IL-1β for distinguishing peri-implantitis will be evaluated using receiver operating characteristic (ROC) analyses, and potential threshold values will be explored. The project is expected to provide novel insights into the role of local inflammatory biomarkers in peri-implant diseases among postmenopausal women, contribute to the identification of high-risk individuals, and support the development of personalized preventive and therapeutic strategies.
Visão geral do estudo
Status
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Locais de estudo
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Istanbul, Turquia (Türkiye), 34200
- Istanbul Medipol University
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Postmenopausal status, defined as amenorrhea for at least 12 months
- Aged 45-70 years
- Presence of at least one functional dental implant
- Completed and functional implant-supported prosthetic restoration
- Implant in function for at least 1 year after prosthetic loading
- No systemic or local condition preventing clinical or radiographic assessment
- Provision of written informed consent
Exclusion Criteria:
- Current smoking
- Presence of uncontrolled systemic disease
- Use of antibiotics or anti-inflammatory medications within the past 3 months
- Periodontal or peri-implant surgical treatment within the past 6 months
- History of radiotherapy to the head and neck region or chemotherapy
- Any condition preventing reliable clinical, radiographic, or biochemical assessment
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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Postmenopausal Peri-implant Health
Postmenopausal women with healthy peri-implant tissues, without clinical signs of inflammation or pathological bone loss.
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Postmenopausal Peri-implant mucositis
Postmenopausal women with peri-implant soft tissue inflammation without progressive bone loss.
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Postmenopausal Peri-implantitis
Postmenopausal women with peri-implant inflammation and progressive supporting bone loss.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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IL-1B levels
Prazo: baseline
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Saliva and Peri-implant Sulcular Fluid Interleukin-1B (IL-1b) Levels measured by ELISA
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baseline
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aMMP-8 levels
Prazo: baseline
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Saliva and Peri-implant Sulcular Fluid active-Matrix Metalloproteinase-8 (aMMP-8) Levels measured by ELISA
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baseline
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Marginal bone loss
Prazo: baseline
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Marginal bone levels will be measured mesially and distally on standardized periapical radiographs using a fixed implant reference point.
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baseline
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
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Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
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Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
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- 335
Plano para dados de participantes individuais (IPD)
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