Impact of Smoking on Macrophage-Related Chemokines During Initial Peri-implantitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Biochemical Outcomes
研究概览
简要总结
Peri-implantitis is a condition affecting tissues around dental implants, leading to inflammation and bone loss. Smoking is a known risk factor that increases the risk of developing peri-implantitis and reduces treatment success. Smokers often have worse outcomes after treatment compared to non-smokers.
Macrophage activity is crucial for fighting infections, but smoking can impair their function, leading to tissue damage. Smoking reduces blood flow and oxygen levels in tissues, hindering healing. Specific chemokines (CCL-2, CCL-8, CXCL-9, and CCL-3) help direct immune responses by recruiting macrophages and other immune cells to infection sites. Understanding how smoking affects these chemokines is essential for improving peri-implantitis treatment outcomes. Peri-implantitis is a complex condition caused by various factors, which makes it challenging to study how smoking affects the immune response in advanced stages of the disease. This study aims to investigate how smoking influences specific chemical signals associated with the immune response (CCL-2, CCL-8, CCL-3, and CXCL-9) in the fluid around dental implants, both before and after non-surgical treatment. The research will compare smokers to non-smokers during the early stages of peri-implantitis.
详细描述
- Ethics Approval and Determination of Sample Size
The study was approved by the Clinical Research Ethics Committee of Başkent University, Ankara, Türkiye (Study protocol number: D-KD24/01) in accordance with the Helsinki Declaration of 1975, as revised in 2013.
The power analysis was conducted using GPower software. Based on previous research comparing pre- and post-treatment MIP-1α levels in PICF samples, the required minimum sample size was calculated to be 52 participants, with 26 participants in each group in order to achieve a power of 80% (effect size f = 0.2; α error = 0.05). Estimating a drop-out rate of 20%, the present study aimed to recruit 63 patients. 2. Study Design
Study planning, patient recruitment, treatments, and sample collection were performed at the clinics of the Department of Periodontology, Faculty of Dentistry, Gazi University, Türkiye, between January 2024 and October 2024. All individuals who were diagnosed with peri-implantitis (peri-implant bleeding on probing (BOP+) and/or suppuration, PPD of ≥ 6 mm, and radiographic crestal bone loss of ≥ 3 mm apical of the most coronal portion of the intraosseous part of the dental implant at their initial visit at the periodontology clinics of Gazi University Faculty of Dentistry, were invited to take part in the study. 3. Inclusion and Exclusion Criteria
Inclusion criteria were: 1) willingness to participate in the study, 2) having a dental implant that was loaded at least one year before the initiation of the study, that was diagnosed with peri-implantitis, and that has PD of 6-7 mm, 3) the implants had been in function for at least 1 years. Exclusion criteria were: 1) having received periodontal therapy or any oral decontamination treatment or received antibiotics or steroids in the last six months before the initiation of the study, 2) being pregnant or breastfeeding, 3) being diagnosed with rheumatoid arthritis, lupus erythematosus, poorly controlled systemic diseases (such as diabetes or hypertension), 4) having a medical history of radiation or cancer therapy. 4. Study population
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •willingness to participate in the study
- •having a dental implant that was loaded at least one year before the initiation of the study, that was diagnosed with peri-implantitis, and that has PD of 6-7 mm, 3) the implants had been in function for at least 1 year.
排除标准
- •having received periodontal therapy or any oral decontamination treatment or received antibiotics or steroids in the last six months before the initiation of the study,
- •being pregnant or breastfeeding,
- •being diagnosed with rheumatoid arthritis, lupus erythematosus, poorly controlled systemic diseases (such as diabetes or hypertension),
- •having a medical history of radiation or cancer therapy.
研究组 & 干预措施
Peri-implantitis patients
All peri-implantitis patients in both smoking and non-smoking groups received full-mouth non-surgical periodontal treatment using sterile ultrasonic scalers (Woodpecker Piezo Cavitron Ultrasonic Scaler Handpiece (HW-5L), EMS, Switzerland)), currets (Lsh6-h7, Osung MND, Korea), and sterile saline irrigations. Non-surgical treatment of peri-implantitis involves the debridement of hard- and soft accumulations on implant surfaces using titanium curettes (Titanium Implant Scaler 204SD, Hu-Friedy) for 15 minutes, followed by irrigation with sterile saline solution
干预措施: Debridement of implant surface with titanium curettes and irrigation with sterile saline solution (Procedure)
结局指标
主要结局
Biochemical Outcomes
时间窗: Assessment and comparison of peri-implant crevicular fluid chemokine levels before and four months after non-surgical treatment of initial peri-implantitis in smoking and non-smoking individuals
Analysis and comparison of peri-implant crevicular fluid levels of CCL-2, CCL-3, and CXCL-9 before and after non-surgical treatment of initial peri-implantitis in smokers and non-smokers.
次要结局
- Probing Pocket Depth (mm)(Assessment and comparison of clinical outcomes for non-surgical treatment of peri-implantitis before and after four months.)
- Bleeding on Probing(Assessment and comparison of clinical outcomes for non-surgical treatment of peri-implantitis before and after four months.)
- Visible Plaque Score(Assessment and comparison of clinical outcomes for non-surgical treatment of peri-implantitis before and after four months.)
研究者
Buse Naz BÜYÜKAKÇALI ALTAY
Principal Investigator, Research Assistant
Gazi University