Regular Home Use of Dual-light Photodynamic Therapy as an Adjunct to Non-surgical Periodontal Treatment in Smokers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes in bleeding on probing (BOP)
研究概览
简要总结
The goal of this controlled clinical trial is to investigate the impact of regular home use of Lumoral device as an adjunct treatment compared to non-surgical periodontitis treatment (NSPT) alone on biofilm removal and host response in Stage III and Grade C smoking periodontitis patients at 6 months.The main question aims to answer is:
• Does regular use of dual-light photodynamic therapy benefit NSPT in Stage III and Grade C smoking periodontitis patients?
30 participants will be asked to use Lumoral device every night before performing oral hygiene for 10 minutes, while the other 30 patients will be asked to perform only oral hygiene. Both of these groups will receive NSPT and will be followed for 6 months from baseline.
详细描述
The objective of this study is to investigate the impact of regular home use of Lumoral device® as an adjunct treatment compared to non-surgical periodontal treatment alone on biofilm removal and host response in Stage III and Grade C smoking periodontitis patients at 6 months.
Lumoral® is based on a dual-wavelength LED light that activates Lumorinse® (exocellular) and bacteria porphyrins (endocellular), resulting in the formation of reactive oxygen species (ROS). ROS and heat induce a series of photochemical and biological events that cause irreversible inactivation leading to the death of undesired bacteria. This device is designed for home use.
Therefore it is hypothesized that its adjunct use in the treatment of periodontitis could lead to better outcomes compared to traditional periodontal treatment. In order to investigate this impact, clinical and microbiological measurements will be compared between patients who will be treated with conventional non-surgical periodontal treatment and patients who will receive the Lumoral device® as an adjunct to the periodontal treatment. The patients who receive the device will use it every day for four months. Both groups will be followed for 6 months.
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
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Periodontal disease Stage III and Grade C with at least 6 sites with probing depth (PD) and clinical attachment loss (CAL) ≥5 mm and bleeding on probing (BoP) ≥15 teeth
- •Smokers smoking ≥10 cigarettes per day
排除标准
- •Patients allergic to indocyanine
- •Patients with active carious lesions
- •Need for prophylactic antimicrobial coverage
- •Scaling and root planing in the previous 6 months
- •Non-smoking status or smoking less than 10 cigarettes per day
- •Antimicrobial therapy in the previous 6 months
- •Immunomodifying conditions/ diseases (e.g. diabetes mellitus, rheumatoid arthritis, osteoporosis)
- •Long-term use of medication that could interfere with periodontal response (e.g. biphosphonates)
- •Pregnancy or lactation
结局指标
主要结局
Changes in bleeding on probing (BOP)
时间窗: baseline, 2 weeks, 2 months, 6 months
Changes in the presence of bleeding when probing at 6 sites per tooth. It is evaluated dichotomously.
次要结局
- a-MMP8 saliva concentration(baseline, 2 weeks, 2 months, 6 months)
- Changes of pocket depths(baseline, 2 months, 6 months)
- Oral health-related quality of life questionnaire (OHQL)(2 months, 6 months)
- Changes in clinical attachment level(baseline, 2 months, 6 months)
- Difference in the number of "closed" pockets(baseline, 2 months, 6 months)
- Changes in Turetsky Modified Quigley-Hein Plaque Index (TMQHPI)(baseline, 2 weeks, 2 months, 6 months)
- Changes in the presence of periopathogens in the deepest pocket(baseline, 2 months, 6 months)
研究者
Dimitra Sakellari
Professor
Aristotle University Of Thessaloniki