Regular Home Use of Dual-light Photodynamic Therapy in the Management of Chronic Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 6
- 主要终点
- Stabilization of the periodontal disease
研究概览
简要总结
This early-stage research is designed to determine the efficacy of the Lumoral method in chronic periodontitis patients. Improved supragingival plaque control can help to also sustain the subgingival plaque management in the long term. In addition, the device might have a photobiomodulation effect on periodontal tissues.
详细描述
Periodontitis is a chronic inflammatory disease leading to a progressive loss of the tooth-supporting apparatus. The disease is strongly associated with deranged biodiversity patterns in dental plaque.
The Lumoral is a CE-marked medical device developed to provide a potent, targeted antibacterial action on dental plaque in a home environment. The device mechanism of action is antibacterial photodynamic therapy. The device is used by swishing a mouth rinse, which has a strong adherence to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple to use light applicator. The antibacterial efficacy far exceeds chlorhexidine, without side effects in a longterm use. Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction.
Ninety (90) stage I-III periodontitis patients are randomized to Lumoral treatment group or control group. Both groups shall receive mechanical plaque control by scaling and root planning (SRP) and standard oral hygiene instructions for electric toothbrush, interdental brush, and dental floss use. All the patients shall be assessed for the clinical periodontitis status. These assessment and analyses shall be performed at baseline, at 3 months and at 6 months after the treatment.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
The subjects will be randomized to the study group and the control group by using a sealed envelope system.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Periodontal disease stage I-III, according to criteria the American Academy of Periodontology (AAP) with at least 2 mm interdental CAL in the site of greatest loss.
- •Age of 18- 85 years
- •Presence of ≥20 teeth, including implants
- •Agreement to participate in the study and to sign a written consent form
- •Able to co-operate with the treatment protocol and avoid any other oral hygiene measures outside of the study protocol
排除标准
- •Presence of major physical limitation or restriction that prohibit the hygiene procedures used in the study protocol
- •Removable major prosthesis or major orthodontic appliance
- •Pregnancy or lactation
- •Use of antibiotics within 2 weeks prior the study
- •A need for immediate antimicrobial treatment for periodontitis
结局指标
主要结局
Stabilization of the periodontal disease
时间窗: 6 months
Possible changes in the periodontal disease, measured by total probing pocket depth (PPD) progression in the patient mouth at 6 months compared to baseline
Reduction in dental inflammation
时间窗: 6 months
Possible changes in dental inflammation measured by bleeding on probing (BoP) when compared to control group at 6 months compared to baseline
次要结局
- Improvement in clinical attachment level (CAL) reflecting the clinical periodontitis status(6 months)
- Improvement in probing pocket depth (PPD) reflecting the clinical periodontitis status(6 months)
- Change in periodontal microbiological pathogens.(6 months)
- Reduction in aMMP-8 measurement(6 months)
- Improvement in oral-related quality of life.(6 months)