Comparing Treatment of Peri-implantitis With Either 970 nm Laser or Conventional Mucosal Flap Surgery - a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 4
- 主要终点
- Mean change in pocket probing depth (PPD)
研究概览
简要总结
A clinical trial comparing laser treatment and conventional mucosal flap surgery for treatment of peri-implantitis. The main aim of the study is to evaluate if treatment of peri-implantitis with 970 nm laser combined with scaling and root planning (SRP) is clinically comparable to conventional mucosal flap surgery in terms of pocket probing depth reduction.
详细描述
The present project aims to evaluate a novel method in treating peri-implantitis, with focus on decreasing the patient's suffering as well as disease progression. Peri-implantitis has a direct influence on both physical and psychological wellbeing and have been related to difficulty in chewing due to loss of implants, bad esthetic appearance as well as high costs. Therefore, it is of importance for the individual as well as for the society to thoroughly investigate any new treatment approaches.
The study is a prospective randomized clinical trial comparing laser treatment (test group) and conventional mucosal flap surgery (active control group). Assessment of clinical variables at baseline and after 6 months. Patient reported outcomes at baseline, directly after treatment and after 10 days.
Primary Objective:
To evaluate if treatment of peri-implantitis with 970 nm laser combined with scaling and root planning (SRP) is clinically comparable to conventional mucosal flap surgery in terms of pocket probing depth reduction.
Secondary Objectives:
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
Masking for the assessors of microbial, immunological and radiographic analyses.
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
- •Signs of peri-implantitis around one or more dental implants. All criteria below need to be fulfilled for inclusion.
- •Presence of pocket probing depth (PPD) > 5 mm
- •Bleeding on probing/suppuration (BOP/Pus)
- •At least 2 mm loss of bone, visible on radiographs, after initial osseointegration.
- •≥ 18 years old.
- •Patient able to understand Swedish.
排除标准
- •Antibiotic treatment 6 months prior to baseline.
- •Peri-implant treatment 6 months prior to baseline.
- •Myocardial infarction 6 months prior to baseline.
- •Previous radiation treatment in the affected jaw area.
- •Previous i.v. bisphosphonate treatment.
- •Moderate or severe impairment of cognitive function (e.g. dementia).
结局指标
主要结局
Mean change in pocket probing depth (PPD)
时间窗: 0-6 months
Pocket probing depth (PPD) will be measured by a 1 mm graded pocket probe from the bottom of the peri-implant pocket to the marginal mucosa and will be registered on 4 surfaces surrounding the implant.
次要结局
- Mean change in plaque index (PI)(0-6 months)
- Mean change in bleeding on probing (BOP)(0-6 months)
- Composition of the subgingival microflora(0-6 months)
- Mean change in patient reported outcome using the visual analogue scale (VAS) score(Baseline, directly after treatment, 10 days after and 6 months after treatment.)
- Mean change in inflammatory response in saliva(0-6 months)
- Mean change in presence of suppuration(0-6 months)
- Mean change in marginal bone level on radiographs(0-6 months)
- Mean change in inflammatory response in peri-implant crevicular fluid (PICF)(0-6 months)
研究者
Annsofi Johannsen
Associate professor
Karolinska Institutet