Regular Home-use of Dual-light Photodynamic Therapy in the Management of Chronic Stage III-IV Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Bleeding on probing (BOP)
研究概览
简要总结
This study is designed to determine the efficacy of the Lumoral method in chronic periodontitis with a targeted group of stage III and IV periodontitis.
Improved supragingival plaque control can help to also sustain the subgingival plaque management in the long term.
In addition, the method might have a photobiomodulation effect on periodontal tissues.
详细描述
The 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 (aPDT). The device is used by swishing a specially designed mouth rinse that strongly adheres to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple-to-use light applicator. Preliminary results have shown promising anti-inflammatory responses in addition to plaque reduction.
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
- Single (Outcomes Assessor)
盲法说明
All clinical assessments at baseline and at 6 months shall be performed by one calibrated examiner who is blinded for the subjects' allocation to the study and control groups.
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 III-IV, according to criteria the American Academy of Periodontology (AAP) with at least 3 mm interdental clinical attachment level (CAL) in the site of greatest loss.
- •≥ 18 years old
- •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
- •Grade A or C periodontitis
- •Presence of any physical limitation or restriction that might restrict Lumoral use
- •Pregnancy or lactation
- •Active smoking
- •Medicated diabetes mellitus (DM)
- •Any systemic disease (e.g., wound healing dysfunctions) that could alter the progression of periodontal disease
- •Use of antibiotics within 4 weeks week prior study
- •Periodontal treatment within 3 months prior study
- •Removable major prosthesis or major orthodontic appliance
- •A need for a hopeless teeth extraction, or open cavities in need for immediate endodontic treatment
研究组 & 干预措施
Study group
A complete clinical intraoral examination shall be performed for all subjects. Same demographic and clinical data will be obtained from subjects in both arms. The study group shall receive the Lumoral treatment -device, Lumorinse -tablets and instructions for their use.
All subjects shall receive standard oral hygiene instructions for the use of an electric toothbrush, interdental brush, and dental floss.
干预措施: Lumoral Treatment (Device)
Control group
A complete clinical intraoral examination shall be performed for all subjects. Same demographic and clinical data will be obtained from subjects in both arms. All subjects shall receive standard oral hygiene instructions for the use of an electric toothbrush, interdental brush, and dental floss.
结局指标
主要结局
Bleeding on probing (BOP)
时间窗: 6 months
Improvement in bleeding on probing (BOP) * 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
- Active matrix metalloproteinase 8 (aMMP-8)(6 months)
- Visible plaque index (VPI)(6 months)
- Deep periodontal pockets (over 4 mm)(6 months)
- Probing pocket depth (PPD)(6 months)
- Clinical attachment level (CAL)(6 months)
- Additional visits(6 months)
- OHIP-14(6 months)
- Periodontal microbiological flora(6 months)