Effect of Probe Material (Metallic vs. Plastic) on Peri-implant Probing: a Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Difference in probing depth with vs. without prosthesis (ΔPS, mm)
研究概览
简要总结
Evaluate whether the type of probe (plastic vs. metallic) modifies the accuracy of peri-implant probing in single-unit implants, by comparing the probing depth recorded with the prosthesis in place versus without the prosthesis (ΔPD, mm). Secondarily, explore the influence of prosthetic design and implant position on probing values and on other clinical and radiographic parameters.
详细描述
Randomized clinical trial with two parallel groups. Eligible patients will be randomized (1:1 ratio) to one of two parallel treatment groups:
Group 1 (Metal probe): Peri-implant probing performed with a UNC-15 metallic periodontal probe (HuFriedy PCPUNC156).
Group 2 (Plastic probe): Peri-implant probing performed with a UNC-15 plastic periodontal probe (HuFriedy PCVO12PT).
Primary objective:
To evaluate whether the type of probe (plastic vs metallic) modifies the accuracy of peri-implant probing in single-unit implants, by comparing the probing depth recorded with the prosthesis in place versus without the prosthesis (ΔPS, mm).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, 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
- •Adults (≥18 years)
- •Presence of at least one single-unit bone-level implant rehabilitated with a screw-retained prosthesis directly connected to the implant (no intermediate abutment)
- •Implant in function for at least 1 year after prosthetic loading
- •No pathological bone loss on periapical radiograph (distance from the most coronal rough surface of the implant to the bone crest < 3 mm)
- •Ability to understand and sign informed consent
- •Peri-implant health or mucositis, defined according to the 2017 World Workshop criteria:
- •Health: no clinical signs of inflammation, lack of profuse (line or drop) bleeding on probing, no increase in probing depth compared to previous records, and no progressive bone loss beyond initial remodeling (<2 mm). In the absence of previous radiographs, radiographic bone level <3 mm without bleeding and/or suppuration on probing.
- •Mucositis: presence of bleeding and/or suppuration on probing, no increase in probing depth compared to previous records, and no bone loss beyond initial remodeling (<2 mm). In the absence of previous radiographs, radiographic bone level <3 mm with bleeding and/or suppuration on probing.
排除标准
- •Cement-retained restorations or prostheses that cannot be removed
- •Systemic antibiotic or anti-inflammatory treatment within the previous 3 months
- •Pregnancy or lactation
- •Peri-implant treatment within the previous 3 months
- •Participation in another clinical trial within the last 30 days
研究组 & 干预措施
Metallic probe
Metallic UNC-15 periodontal probe (HuFriedy PCPUNC156)
干预措施: Metallic UNC-15 periodontal probe (Device)
Plastic probe
Plastic UNC-15 periodontal probe (HuFriedy PCVO12PT)
干预措施: Plastic UNC-15 periodontal probe (Device)
结局指标
主要结局
Difference in probing depth with vs. without prosthesis (ΔPS, mm)
时间窗: Baseline (single clinical visit)
Difference in peri-implant probing depth (ΔPS) between plastic and metallic probes, measured by a single calibrated examiner at six sites per implant using a standardized probing force (20-25 g). Unit of Measure: millimeters (mm) This primary outcome was defined following the mandatory outcome domains recommended by the international consensus on Implant Dentistry Core Outcome Set and Measurement (ID-COSM), published in the Journal of Clinical Periodontology in 2023.
次要结局
- Patient Discomfort During Probing (VAS, 0-100 mm)(Immediately after probing, at the study visit)
研究者
Octavi Camps-Font
Associate Professor
University of Barcelona