Randomized, Controlled, Exploratory Study on the Treatment of Dental Implants Using the AmbiJet System for Peri-implantitis and Peri-implant Mucositis (AmbiJet-FIH)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Macroscopic tissue reaction measured via Implant Mucosal Index (IMI)
研究概览
简要总结
Inflammation of the tissue surrounding a dental implant (peri-implantitis or peri-implant mucositis) can lead to implant loss in advanced stages. The AmbiJet system utilizes cold atmospheric plasma (CAP), a physical procedure with a strong antibacterial effect. This clinical trial investigates whether the additional application of cold plasma directly on the patient following conventional mechanical cleaning of the implants is safe, well-tolerated, and resolves inflammation more quickly compared to standard treatment.
详细描述
Background:
Developments in materials, improvements in techniques, and knowledge of the influence of patient characteristics have led to the increasing use of endosseous dental implants. Initially, a bony connection to the implant surface is established, but biofilm deposits on the implant and associated inflammatory reactions of varying severity can develop, namely peri-implant mucositis and peri-implantitis.
Peri-implant mucositis is the early stage of the disease: a reaction of the soft tissue (gums) around the implant. Peri-implantitis is the advanced stage of the disease and refers to inflammation that has a negative effect on integration into the bone.
Studies from university and private clinics with at least 100 implants reported between 2005 and 2014 showed prevalence data of 43% - 46.83% for peri-implant mucositis and 19.83% - 22% for peri-implantitis. Peri-implant mucositis and periimplantitis have bacterial pathogenesis, although the spectrum of microorganisms varies. Peri-implantitis is more serious because it attacks the bony implant support apparatus and can lead to implant loss in half of all cases. Treatment of peri-implant mucositis counteracts the development of peri-implantitis.
Therefore, according to the S3 guideline, three months of follow-up care is indicated.
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
- None
盲法说明
Blinding is not possible due to the physical nature of the medical device intervention.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General criteria:
- •Men or women aged >= 18 and <= 65 years.
- •For women of childbearing age: a form of contraception recognized by conventional medicine during the study.
- •Written consent has been obtained from each patient for the study.
- •Dental criteria:
- •Current X-ray of the implant region available (<= 6 months prior to first treatment).
- •One to five implants with bone loss from the start of the part of the implant intended for osseointegration (X-ray findings).
- •Bleeding and/or suppuration after or without probing at the implant in question (peri-implant mucositis/peri-implantitis).
- •Clinical signs of inflammation (swelling, redness, soft tissue) on the implant in question (peri-implant mucositis/peri-implantitis).
- •Average oral hygiene (i.e., brushing teeth at least twice a day).
排除标准
- •General criteria:
- •Known allergies to materials used in the study (gold, copper, polyimide).
- •Diabetes (type I or type II), vasculitis, osteoporosis, osteomalacia.
- •Smokers (>1 cigarette/week).
- •Use of medications to modulate bone metabolism (e.g., bisphosphonates).
- •Eating disorders such as bulimia or anorexia nervosa.
- •Use of antibiotics within the last 2 months prior to the start of the study.
- •Application of local antibiotics in the oral cavity within the last 2 months prior to the start of the study.
- •Use of antimicrobial mouthwashes within the last month before the start of the study.
- •Anti-inflammatory medication within the last month before the start of the study.
- •Pregnancy or breastfeeding.
- •Alcoholism or drug abuse.
- •Wound healing disorders.
- •Immunosuppression.
- •Condition following insertion of an electrical, electrically active, or electronic implant.
- •Dental criteria:
- •An implant with bone loss >6 mm from the start of the part of the implant intended for osseointegration (X-ray findings) (peri-implantitis).
- •Pathological changes in the oral mucosa or gingiva, such as oral lichen planus, chronic recurrent aphthae, melanotic macula, precancerous lesions (e.g., leukoplakia), melanomas.
- •Use of medically unacceptable types of treatment, therapies, or substances (off-label use of treatments for peri-implant mucositis or peri-implantitis).
研究组 & 干预措施
Standard Mechanical Debridement (S3)
Guideline-compliant standard therapy only, consisting of mechanical, non-surgical debridement of mineralized and non-mineralized biofilm, including rinsing with saline solution and powder jet treatment.
干预措施: Standard Mechanical Debridement (S3 Guideline) (Procedure)
AmbiJet Cold Plasma + Standard Debridement
Adjuvant application of cold atmospheric pressure plasma using the AmbiJet system directly onto the affected implant surfaces, performed immediately following standard mechanical debridement according to the S3 guideline.
干预措施: AmbiJet cold plasma system (Device)
AmbiJet Cold Plasma + Standard Debridement
Adjuvant application of cold atmospheric pressure plasma using the AmbiJet system directly onto the affected implant surfaces, performed immediately following standard mechanical debridement according to the S3 guideline.
干预措施: Standard Mechanical Debridement (S3 Guideline) (Procedure)
结局指标
主要结局
Macroscopic tissue reaction measured via Implant Mucosal Index (IMI)
时间窗: Baseline, 1 week, and 4 weeks after initial treatment
Evaluation of local acute tissue reactions and toxicity (such as necrosis, severe inflammation, erosion, pigmentation changes, or burns) in the peri-implant mucosa. The IMI score ranges from 0 (healthy, no inflammation) to 3 (severe inflammation, spontaneous bleeding, or pus discharge).
Acute pain and post-interventional morbidity measured via Visual Analog Scale (VAS)
时间窗: Immediately after treatment, 1 week, and 4 weeks after initial treatment
Measurement of the intensity of the patient's pain response during and after the treatment using a standard Visual Analog Scale (VAS).
Macroscopic tissue reaction measured via Implant Mucosal Index
时间窗: Baseline, 1 week, and 4 weeks after initial treatment
Evaluation of local acute tissue reactions and toxicity in the peri-implant mucosa using the Implant Mucosal Index (IMI). The IMI scale ranges from a minimum score of 0 (healthy tissue, no signs of inflammation) to a maximum score of 3 (severe inflammation, pronounced swelling, spontaneous bleeding, or pus discharge). Higher scores indicate a worse outcome (more severe tissue inflammation).
Acute pain and post-interventional morbidity measured via Visual Analog Scale
时间窗: Immediately after treatment, 1 week, and 4 weeks after initial treatment
Measurement of the intensity of the patient's pain response during and after treatment using a Visual Analog Scale (VAS). The VAS scale ranges from a minimum score of 0 (no pain) to a maximum score of 10 (worst imaginable pain). Higher scores indicate a worse outcome (greater pain intensity).
次要结局
未报告次要终点