Comparison of Peri-Implant Tissue Health and Biomarker Outcomes Between Short and Standard Dental Implants: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Peri-Implant Crevicular Fluid RANKL Level
研究概览
简要总结
This study compares two types of dental implants, short implants (6 millimeters or less in length) and standard implants (longer than 8 millimeters), to evaluate their effect on the health of the gum and bone tissue surrounding the implant. Approximately 40 patients receiving a total of 80 dental implants will be followed. Researchers will assess clinical signs of gum health around the implants, measure specific protein levels (biomarkers) in the fluid surrounding the implants associated with gum disease. The goal of this study is to determine whether implant length affects the risk of inflammation or infection around dental implants, which may help guide treatment decisions in the future.
详细描述
This is a prospective study enrolling approximately 40 patients who will receive a total of 80 dental implants, categorized as short (≤6 mm) or standard (>8 mm) in length. Peri-implant crevicular fluid (PICF) samples will be collected at baseline from all patients. In patients who develop peri-implant mucositis, an additional PICF sample will be collected at 1 and 3 months. PICF samples will be analyzed by ELISA for RANKL, OPG, cathepsin-K, and cytokine levels. Implant diameter and length will be recorded for each patient. Clinical parameters of peri-implant tissue health will also be assessed at each visit. The study aims to compare biochemical and clinical outcomes between short and standard implants to determine whether implant length influences peri-implant tissue health.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy adults aged 18-70 years.
- •Presence of at least one short (≤6 mm) and/or standard (>8 mm) dental implant in function for at least 2 years.
- •Patients presenting to the Department of Periodontology, Faculty of Dentistry, Inonu University, for routine dental examination.
- •For the peri-implant health group: absence of clinical signs of inflammation (redness, edema, or suppuration), absence of bleeding on probing (BOP), probing pocket depth (PPD) ≤5 mm, full-mouth BOP <10%, no radiographic evidence of pathological peri-implant bone loss, and no clinical implant mobility.
- •For the peri-implant mucositis group: presence of clinical signs of inflammation (redness and/or edema) without suppuration, presence of bleeding on probing (BOP), probing pocket depth (PPD) ≤5 mm, full-mouth BOP >10%, no radiographic evidence of pathological peri-implant bone loss, and no clinical implant mobility.
排除标准
- •Age younger than 18 years or older than 70 years.
- •Presence of any systemic disease.
- •Immune system disorders or use of immunosuppressive medications.
- •Requirement for antibiotic prophylaxis before dental procedures.
- •Bisphosphonate therapy for osteoporosis.
- •Pregnancy or lactation.
- •Alcohol consumption.
- •Antibiotic treatment within the previous 6 months.
- •Continuous use of systemic medications.
研究组 & 干预措施
Short implant group
Patients receiving dental implants with a length of 6 mm or less. Peri-implant crevicular fluid (PICF) samples will be collected to assess RANKL, OPG, and cathepsin-K levels, along with clinical peri-implant tissue health parameters
Standard Implant Group
Patients receiving dental implants with a length greater than 8 mm. Peri-implant crevicular fluid (PICF) samples will be collected to assess RANKL, OPG, and cathepsin-K levels, along with clinical peri-implant tissue health parameters.
结局指标
主要结局
Change in Peri-Implant Crevicular Fluid RANKL Level
时间窗: Baseline; 1 and 3 months after non-surgical peri-implant therapy in participants who develop peri-implant mucositis.
Receptor activator of nuclear factor kappa-B ligand (RANKL) levels in peri-implant crevicular fluid (PICF) will be measured using enzyme-linked immunosorbent assay (ELISA) and compared between short and standard implant groups.
Change in Peri-Implant Crevicular Fluid OPG Level
时间窗: Baseline; 1 and 3 months after non-surgical peri-implant therapy in participants who develop peri-implant mucositis.
Osteoprotegerin (OPG) levels in peri-implant crevicular fluid (PICF) will be measured using enzyme-linked immunosorbent assay (ELISA) and compared between short and standard implant groups.
Change in Peri-Implant Crevicular Fluid Cathepsin K Level
时间窗: Baseline; 1 and 3 months after non-surgical peri-implant therapy in participants who develop peri-implant mucositis.
Cathepsin K levels in peri-implant crevicular fluid (PICF) will be measured using enzyme-linked immunosorbent assay (ELISA) and compared between short and standard implant groups.
次要结局
- Change in Peri-Implant Probing Depth(Baseline; 1 and 3 months after non-surgical peri-implant therapy in participants who develop peri-implant mucositis.)
- Change in Peri-Implant Bleeding on Probing(Baseline; 1 and 3 months after non-surgical peri-implant therapy in participants who develop peri-implant mucositis.)
- Change in Peri-Implant Plaque Index(Baseline; 1 and 3 months after non-surgical peri-implant therapy in participants who develop peri-implant mucositis.)
- Change in Gingival Index(Baseline; 1 and 3 months after non-surgical peri-implant therapy in participants who develop peri-implant mucositis.)
研究者
Kubra Aral
Associate Professor, Department of Periodontology, Faculty of Dentistry
Inonu University