Comparing Two Treatment Modalities of Peri-implantitis - Blue Laser (445 nm) and Conventional Flap Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Mean change from baseline in Pocket probing depth (PPD) at 6 months after treatment.
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 a novel blue laser (445 nm) 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 well-being 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 a novel blue laser (445 nm) 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).
研究组 & 干预措施
Scaling and root planning + Laser treatment
干预措施: Laser treatment (Device)
Mucosal flap surgery
干预措施: Mucosal flap surgery (Procedure)
结局指标
主要结局
Mean change from baseline in Pocket probing depth (PPD) at 6 months after treatment.
时间窗: At baseline and 6 months post treatment
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 from baseline in Bleeding on probing (BOP) at 6 months after treatment.(At baseline and 6 months post treatment)
- Mean change from baseline in Patient reported outcome using the VAS score directly post treatment.(At baseline and immediately post treatment.)
- Bacterial composition of the subgingival microflora(At baseline and 6 months post treatment)
- Mean change from baseline in Plaque index (PI) at 6 months after treatment.(At baseline and 6 months post treatment)
- Mean change from baseline in the inflammatory response in the inflammatory exudates at 6 months after treatment.(At baseline and 6 months post treatment)
- Mean change from baseline in Recession of the marginal mucosa at 6 months after treatment.(At baseline and 6 months post treatment)
- Mean change from baseline in Patient reported outcome using the VAS score at 10 days post treatment.(At baseline and 10 days post treatment.)
- Mean change from baseline in Presence of suppuration at 6 months after treatment.(At baseline and 6 months post treatment)
- Mean change from baseline in Marginal bone level on radiographs at 6 months after treatment.(At baseline and 6 months post treatment)
研究者
Annsofi Johannsen
Registered Dental Hygienist (RDH); Associate professor
Karolinska Institutet