The Efficacy of Electrolysis Decontamination with or Without Leukocyteplatelet Rich Fibrin (L-PRF) in the Surgical Treatment of Peri-implantitis Defects: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 57
- 主要终点
- Probing pocket depth
研究概览
简要总结
The aim of this study is to evaluate the efficacy of implant surface decontamination using electrolysis cleaning system. And to evaluate the adjunctive use of L-PRF in promoting soft tissue healing and long-term stability of the peri-implant marginal bone in the surgical treatment of peri-implantitis.
详细描述
Research design
- Prospective, in which participants will be recruited and then followed up throughout a specified period of time.
- Randomized, parallel designed, concurrent controlled trial with participants randomly allocated to either control or test groups.
- Single-blinded as the outcome accessors will be blinded to the intervention.
Materials and Methods:
Patients attending Dubai Dental Hospital and requiring treatment of peri-implantitis will be invited to take part in this randomized controlled trial based on the following inclusion and exclusion criteria:
Inclusion criteria:
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 or over.
- •Require treatment of peri-implantitis (defined as the presence of bleeding and/or suppuration on gentle probing, probing depths of ≥ 6 mm, presence of bone loss beyond crestal bone level changes resulting from initial bone remodeling).
- •Screw retained implant crown.
- •Good compliance and commitment to attend follow-up review appointments.
- •Willing to provide informed consent.
排除标准
- •History of surgical therapy of peri-implantitis.
- •Peri-implant defects indicated for regenerative procedure (i.e. contained bony defect).
- •Cement retained implant crown.
- •Systemic/local antibiotics during the previous 6 months.
- •Bone metabolic disease and/or taking medications that affect bone metabolism.
- •History of malignancy, radiotherapy or chemotherapy.
- •Pregnant or lactating women.
结局指标
主要结局
Probing pocket depth
时间窗: Baseline (prior to surgical intervention), 3, 6, 12 and 24 months
- Probing pocket depth: measured at baseline (prior to surgical intervention), 3, 6, 12 and 24 months using a manual periodontal probe.
次要结局
- Presence or absence of plaque, bleeding on probing and suppuration(Baseline (prior to surgical intervention), 3, 6, 12 and 24 months)
- Peri-implant marginal bone level(Baseline (prior to surgical intervention), 12 and 24 months)
- Peri-implant soft tissue level(Baseline (prior to surgical intervention), 3, 6, 12 and 24 months)
- Peri-implant soft tissue thickness (Phenotype)(Baseline (prior to surgical intervention), 3, 6, 12 and 24 months)
研究者
Abeer Hakam
Assistant professor
Mohammed Bin Rashid University of Medicine and Health Sciences