The Use of Topical Subgingival Application of Simvastatin Gel in the Treatment of Peri-Implant Mucositis: A Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Change in Interleukin 8 at Base to 24 Hours
研究概览
简要总结
This study seeks to test the recently discovered anti-inflammatory action of statins on inflamed mucosa surrounding dental implants.
Hypothesis: The application of 1.2% simvastatin gel will decrease peri-implant inflammation.
The pilot study will involve 44 subjects divided into a test and control group. The test group shall receive topical simvastatin gel administered around the implant with a blunt tipped needle. The control group will receive a placebo.
Inflammatory state shall be determined at baseline as well as follow up visits at 24 hours, 1 week, and 1 month by clinical indices of inflammation as well as biochemical markers of inflammation gathered from around the implants.
详细描述
Following signing the consent document the following will occur:
- Screening Patients will complete standard medical and dental health history forms, followed by a study specific screening questionnaire. if the patient is deemed eligible, the patient will be examined clinically. The clinical examination will include diagnostic procedures typical of an implant recall visit. Initially, the sulcus will be probed with a periodontal probe; if bleeding on probing is elicited, then a radiograph will be made.
The following shall be done to screen the patients:
- Periapical radiographs of the implant to determine bone loss, if bone loss is found the patient will be excluded from the study.
- Bleeding on probing will be assessed by using a periodontal probe passed along the gingival crevice, and bleeding scores will be assessed passing the probe with a force of 0.25 N.
- If a woman is of childbearing age and suspected of being pregnant, a urine pregnancy test shall be made at this time.
If the patient exhibits no bleeding on probing, or signs of mesial/distal bone loss greater than 1mm from the accepted reference point on the implant system the patient will be excluded from the study. 2. Subject allocation
Subjects will be assigned with equal allocation into the following groups:
- Test group: will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
- Control group: will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri implant gingival sulcus using a plastic syringe with a blunt cannula.
- Baseline measurements Baseline measurements will be made at least 48 hours after screening (allowing time for complete hemostasis of peri-implant crevicular mucosa after bleeding induced by probing in the screening visit).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Only the study coordinator will know whether the intervention is simvastatin or control.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Read, understand, and sign the informed consent forms
- •Have at least 1 dental implant
- •Have no evidence of peri-implantitis as evidenced by mesial and distal bone loss more than 1 mm from the accepted reference point round the implants on the periapical radiograph
- •Demonstrate peri-implant mucositis as evidenced by bleeding on probing with 0.25 N/cm
排除标准
- •Have allergic reactions to simvastatin
- •Have peri-implantitis as evidenced by more than 1 mm of mesial and distal bone loss from an accepted reference point on the implants on the periapical radiograph
- •Demonstrate no bleeding on probing with 0.25 N/ cm
- •Have uncontrolled systemic disease
- •Pregnancy or females who suspect/may be pregnant, as well as nursing and breast feeding mothers
- •Take statin / HMG-CoA reductase inhibitor medications
- •Require antibiotic prophylaxis
- •Take anti-inflammatory medication, immunosuppressive medications or immunosuppressed patients
- •Have paraben allergies
- •Have soybean allergies
研究组 & 干预措施
Simvastatin group (Treatment)
Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
干预措施: Simvastatin (Drug)
Control group
Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.
干预措施: Placebo (Other)
结局指标
主要结局
Change in Interleukin 8 at Base to 24 Hours
时间窗: Baseline - 24 hours
Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)
Change in Interleukin 1 B 24 Hours - 1 Week
时间窗: 24 hours - 1 week
Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)
Change in Interleukin 6 Baseline to 1 Week
时间窗: Baseline - 1 week
Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)
Change in Tumor Necrosis Factor Alpha at Base to 1 Week
时间窗: Baseline - 1 week
Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)
Change in Interleukin 1 B at Base to 24 Hours
时间窗: Baseline- 24hrs
Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)
Change in Interleukin 6 at Base to 24 Hours
时间窗: Baseline - 24 hours
Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)
Change in Interleukin 1 B at Base to 1 Week
时间窗: Baseline - 1 week
Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)
Change in Interleukin 8 24 Hours to 1 Week
时间窗: 24 hours - 1 week
Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)
Change in Tumor Necrosis Factor Alpha at Base to 24 Hours
时间窗: Baseline- 24hrs
Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)
Change in Tumor Necrosis Factor Alpha 24 Hours to 1 Week
时间窗: 24hrs - 1 week
Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)
Change in Interleukin 6 24 Hours - 1 Week
时间窗: 24 hours - 1 week
Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)
Change in Interleukin 8 at Base to 1 Week
时间窗: Baseline - 1 week
Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)
次要结局
- Gingival Index Level (Derived From an Average Over the 4 Implant Sites) at Baseline(Baseline)
- Gingival Index Level (Derived From an Average Over the 4 Implant Sites) at 24 Hours(24 hours)
- Gingival Index Level (Derived From an Average Over the 4 Implant Sites) at 1 Week(1 week)
- Probing Depth Level (Averaged Over 6 Sites) at 1 Week(1 week)
- Probing Depth Level (Averaged Over 6 Sites) at Baseline(Baseline)
- Probing Depth Level (Averaged Over 6 Sites) at 24 Hours(24 hours)
研究者
Ahmed Mohamed Mahrous
Clinical Assistant Professor
University of Iowa