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.
調査の概要
状態
研究の種類
入学 (推定)
連絡先と場所
研究場所
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Istanbul、トルコ(Türkiye)、34200
- Istanbul Medipol University
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
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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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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IL-1B levels
時間枠: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
時間枠: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
時間枠: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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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 335
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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