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
- 202
- 试验地点
- 1
- 主要终点
- Bleeding on Probing (BOP)
研究概览
简要总结
The study is a single site, randomized clinical trial designed to determine the efficacy of the Lumoral treatment in periodontitis patients.
详细描述
Lumoral treatment 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, strongly adhering to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple use light applicator. The antibacterial efficacy far exceeds chlorhexidine, without side effects in long-term use. Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction.
This early-stage study is designed to determine the efficacy of the Lumoral method in periodontitis patients. Improved supragingival plaque control can help to also sustain subgingival plaque management in the long term. In addition, the device might have a photobiomodulation effect on periodontal tissues.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- 是
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
- •Agreement to participate in the study and to sign a written consent form
排除标准
- •Untreated/uncontrollable diabetes mellitus (DM) with HbA1c >7%, and HbA1c > 8 if insulin treated DM
- •Any systemic disease (e.g., wound healing dysfunctions) that could alter the progression of periodontal disease
- •Use of medicine that would affect the periodontal tissue within the last 6 months (antibiotics, anti-inflammatories, anticonvulsants, immunosuppressants, or calcium channel blockers, including doxycycline, bisphosphonates and chlorhexidine)
- •Periodontal treatment during the previous 3 months
- •Allergic to the photosensitizer
- •Presence of major physical limitation or restriction that prohibit the hygiene procedures used in the study protocol
- •Removable major prosthesis or major orthodontic appliance
- •Active smoking, or habitual use of smokeless tobacco products
- •Pregnancy or lactation
- •A need for a hopeless teeth extraction, or open cavities in need for immediate endodontic treatment
结局指标
主要结局
Bleeding on Probing (BOP)
时间窗: 6 months
Clinical change concerning bleeding on probing change. A full-mouth assessment at six sites per tooth (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual). Gingival bleeding is considered as positive if bleeding occurs within 15 seconds after gentle probing with a probe at the sulcus. Dichotomous scoring to each site of the tooth as bleeding "1 present" and "0 absent". BOP is reported as the percentage (%) of sites with positive findings. Calculation formula: number of bleeding sites/ 6 times number of teeth.
次要结局
- Clinical Attachment Level (CAL)(6 months)
- Periodontal Pocket Depth (PPD)(6 months)
- Device-related adverse events(6 months)
- Inflammation marker aMMP-8 measurement(6 months)
- Visual Plaque Index (VPI)(6 months)
- OHIP-14(6 months)
- Patient-related objective: PCS questionnaire(6 months)
- Patient-related objective: OSCA questionnaire(6 months)