Treatment of Peri-implant Mucositis Using an Er:Yag Laser or an Ultrasonic Device. A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Probing pocket depth (PPD)
研究概览
简要总结
The goal of the clinical trial is to compare laser therapy with ultrasonic therapy in patients with inflammation in the tissue surrounding single implants (peri-implant mucositis). The outcomes are bleeding on probing (BOP), pocket depth, suppuration, recession of the peri-implant mucosal margin, the treatment time and changes in bone levels before and after treatment in the test, and control group respectively. The quality of life will be measured from a standardized protocol.
The hypothesis is that treatment with laser therapy in patients with peri-implant mucositis will show less inflammation with less bleeding and a better pocket closure compared to the treatment with the ultrasound.
详细描述
Data from the clinical treatment will be registered in medical records. In parallel, clinical data will be documented in a study protocol and saved in a safe together with a code list in accordance with a standard operation procedure at the clinic.The protocol with the specific treatment procedure (test or control) will not be opened until the study is completed and only by authorized persons with access to the data in the study such as, the principal investigator and the statisticians.
Variables used in the study originates from an international world workshop on the classification of periodontal and peri-implant diseases and conditions in 2018. In accordance with the working group a diagnosis of peri-implant mucositis should include bleeding on probing and or pus and no bone loss (X-ray). In this study the primary outcomes are bleeding on probing (BOP) and or pus and pocket depth,
The aim is to assess the clinical outcome over 6 months following treatment with non-surgical debridement using an Er:Yag laser device (AdvErL EVO, Morita corporation, Japan) (Test group) or with the use of mechanical therapy using an ultrasonic device with a specially designed tip (EMS, Switzerland) (Control group). An active comparator (Control group) was compared to an experimental arm (Test group).
Patients will therefore be randomized into a test or control group. Inclusion criteria will follow a full mouth routine periodontal examination, including analysis of available radiographs.
All measurements will be performed by a dental hygienist who is blinded for the specific treatment test or control. A periodontist will perform all the treatments and is therefore not blinded. Upon the final appointment the specific arm of treatment will be registered by the periodontist in the patient journal.
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
- Single (Outcomes Assessor)
盲法说明
The outcome assessor, in this case the dental hygienist performing the registrations/measurement, is blinded during the whole study
The principal investigator, in this case the periodontologist performing all the treatments, and is therefore not blinded.
入排标准
- 年龄范围
- 23 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 1 peri-implant site with probing depth ≥ 4 mm combined with bleeding and or pus on probing
- •bone loss ≤ 2 mm measured from the implant shoulder (as a consequence of remodelling during the healing process)
排除标准
- •Subjects with uncontrolled diabetes HbA1c >6.5
- •Subjects requiring prophylactic antibiotics
- •Subjects taking prednisolone
- •Subjects taking medications known to have effects on gingival overgrowth
结局指标
主要结局
Probing pocket depth (PPD)
时间窗: 6 months
millimeter
Pus
时间窗: 6 months
Presence or abscence
Bleeding on probing (BOP)
时间窗: 6 months
millimeter
次要结局
- Implant loss(6 months)
- Treatment time(6 months)
- Quality of life (QoL)(6 months)
- Recession of the peri-implant mucosal margin(6 months)
- Bone level (peri-apical radiographs)(6 months)
研究者
Viveca Wallin Bengtsson
Principle investigator
Kristianstad University