- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní místa
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Istanbul, Turecko (Türkiye), 34200
- Istanbul Medipol University
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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IL-1B levels
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
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