Prevention of Dental Implant Diseases: Early Diagnosis and Monitoring in Clinical Work and Enhanced Oral Health Maintenance at Home
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Active matrix metalloproteinase 8 (aMMP-8)
研究概览
简要总结
The aim of this study is to determine the effect of regular antibacterial photodynamic Lumoral® treatment on gingival health and plaque volume, and anti-inflammatory effect of daily double light therapy on implant teeth. The study will use a medical device containing a light-activated Lumorinse® mouthwash and a Lumoral® light activator.
详细描述
The hypothesis is that antibacterial photodynamic therapy improves tissue health by reducing inflammation without any side effect.
Study participants will be invited from a dental clinic in Tampere, Finland, from the patients of an oral hygienist's office. Participants will be randomized to the treatment and control groups using the closed envelope method. Participants in the treatment group will receive Lumoral® treatment according to the manufacturer's protocol, once daily for 10 min for 15 days and then twice daily for 15 days.
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
- Double (Participant, Investigator)
盲法说明
Participants will be randomized at the end of baseline visit
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •One or more dental implants
- •Diagnosis of peri-implantitis
- •Challenges in keeping high self-care oral care standards
- •Over 25 years of age
排除标准
- •Any antibiotic medication within 6 months prior to study participation
结局指标
主要结局
Active matrix metalloproteinase 8 (aMMP-8)
时间窗: 30 days
Change in periodontal inflammation marker aMMP-8
次要结局
- Bleeding on probing (BOP)(30 days)
- Visible plaque index (VPI)(30 days)
研究者
Hanna Lähteenmäki
PhD, Dental Hygienist
Koite Health Oy