Evaluation of aMMP-8 and IL-1β Levels and Marginal Bone Loss Associated With Peri-Implant Mucositis and Peri-Implantitis in Postmenopausal Women

NCT07785817 | Active Not Recruiting

• 1 other identifier: 335
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Postmenopausal Peri-implant Health; Postmenopausal Peri-mucositis; Postmenopausal Peri-implantitis

Outcome Measures

Primary Outcomes (3)

• IL-1B levels

  Saliva and Peri-implant Sulcular Fluid Interleukin-1B (IL-1b) Levels measured by ELISA

  baseline

• aMMP-8 levels

  Saliva and Peri-implant Sulcular Fluid active-Matrix Metalloproteinase-8 (aMMP-8) Levels measured by ELISA

  baseline

• Marginal bone loss

  Marginal bone levels will be measured mesially and distally on standardized periapical radiographs using a fixed implant reference point.

  baseline

Study Arms (3)

Postmenopausal Peri-implant Health

Postmenopausal women with healthy peri-implant tissues, without clinical signs of inflammation or pathological bone loss.

Postmenopausal Peri-implant mucositis

Postmenopausal women with peri-implant soft tissue inflammation without progressive bone loss.

Postmenopausal Peri-implantitis

Postmenopausal women with peri-implant inflammation and progressive supporting bone loss.

Eligibility Criteria

• Age: 45 Years+
• Gender Eligibility Details: Women who are postmenopausal are eligible to participate.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Postmenopausal women aged 45-70 years with at least one functional dental implant will be recruited from patients attending the Periodontology Clinic. Participants will be classified according to their peri-implant clinical and radiographic status as peri-implant health, peri-implant mucositis, or peri-implantitis.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, 34200, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof.Dr.

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: August 25, 2026
• Study Start: March 19, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)