Efficacy of Air-polishing on Pain Perception and Compliance Rate to Periodontal/Peri-implant Maintenance Therapy: a 2-year Follow-up Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Patient Pain/Discomfort (VAS) reported after decontamination during SPT.
研究概览
简要总结
Implants have become a popular and widely used treatment option for treating partial and total edentulism. As the number of implants placed increases, so does the incidence of peri-implant mucositis and peri-implantitis. Placing patients under SPT/maintenance care has been shown to prevent and treat such conditions. Despite SPT's importance in prevention and infection control, adherence to scheduled SPT visits have been unsatisfactory. Understanding the reasons for non-compliance can help both the clinician and research community to address them by improving patients experience to those visits thereby increasing compliance.
详细描述
Objectives:
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General objective Evaluate the patient reported outcomes to a different implant instrumentation method during SPT visits, as well as its effect in compliance rates and clinical outcomes.
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Specific objective
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To evaluate pain/discomfort during SPT around dental implants and teeth.
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To evaluate pain/discomfort during SPT around healthy and diseased dental implants.
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To evaluate patient reported outcomes and clinical variables by decontamination during SPT with erythritol based air polishing powder (Air Flow Master, Air-Flow Plus, EMS, Nyon, Switzerland), at the first SPT, at 1 and 2 years.
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To evaluate the effect of erythritol based air polishing powder (Air Flow Master, Air-Flow Plus, EMS, Nyon, Switzerland) during SPT on the compliance rates after 1 and 2 years of follow-up.
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Hypothesis:
a) General Hypothesis The proposed protocols, focused on the prevention of peri-implantitis, will result in an increase adherence to SPT by better understanding the specific factors related to non-compliance, specifically by improving the experience of patients to SPT visits.
b) Specific Hypothesis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Partially edentulous patients, rehabilitated with at least one dental implant in the maxilla or mandible with at least 3 years of function;
- •No implant mobility;
- •Treated periodontal disease;
- •Non-smoker or light smoking status in smokers (<10 cigarettes/day).
排除标准
- •Patients with diagnosed fibromyalgia disorder or who are taking drugs that might influence the perception of pain (i.e., opioids, gabapentin) will be excluded from the study (Alcalde et al. 2017).
结局指标
主要结局
Patient Pain/Discomfort (VAS) reported after decontamination during SPT.
时间窗: immediately after the procedure
0 = no pain and 10 = extreme, unbearable pain
次要结局
- Changes in Periodontal probing depth (PPD)(24 months)
- Changes in modified Plaque Index (mPI)(24 months)
- Changes in Full mouth plaque index (FMBI)(24 months)
- Compliance to Supportive Periodontal Treatment (SPT) reported after decontamination during SPT.(24 months)
- Changes in Mucosal Recession (MR) around dental implants(24 months)
- Changes in Implants probing depth (implant PPD)(24 months)
- Changes in Full mouth plaque index (FMPI)(24 months)
- Changes in gingival recession (GR)(24 months)
- Changes in modified Bleeding Index (mBI)(24 months)
- Changes in suppuration on probing (SOP)(24 months)
研究者
Tiago Ribeiro Amaral
PhD candidate
Universitat Internacional de Catalunya