Postmenopausal Peri-implant Health, Postmenopausal Peri-implantitis, Postmenopausal Peri-mucositis
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Medipol University
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IL-1B levels | baseline | Saliva and Peri-implant Sulcular Fluid Interleukin-1B (IL-1b) Levels measured by ELISA |
| aMMP-8 levels | baseline | Saliva and Peri-implant Sulcular Fluid active-Matrix Metalloproteinase-8 (aMMP-8) Levels measured by ELISA |
| Marginal bone loss | baseline | Marginal bone levels will be measured mesially and distally on standardized periapical radiographs using a fixed implant reference point. |
Countries
Turkey (Türkiye)
Outcome results
None listed