Postmenopausal Peri-implant HealthNCT07785817
Evaluation of aMMP-8 and IL-1β Levels and Marginal Bone Loss Associated With Peri-Implant Mucositis and Peri-Implantitis in Postmenopausal Women
An observational study of Postmenopausal Peri-implant Health and Postmenopausal Peri-mucositis, run by Medipol University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 45 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Peri-implant Health, Postmenopausal Peri-mucositis, Postmenopausal Peri-implantitis
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Mar 2026to 1 Feb 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-1B levels
Saliva and Peri-implant Sulcular Fluid Interleukin-1B (IL-1b) Levels measured by ELISA
Measured: baseline
aMMP-8 levels
Saliva and Peri-implant Sulcular Fluid active-Matrix Metalloproteinase-8 (aMMP-8) Levels measured by ELISA
Measured: baseline
Marginal bone loss
Marginal bone levels will be measured mesially and distally on standardized periapical radiographs using a fixed implant reference point.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start19 Mar 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal Peri-implant HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emrah Turkmen, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07785817
- Sponsor's protocol ID
- 335
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No