Clinical Outcomes Following Non-Surgical Treatment of Chronic Periodontitis, Using Scaling and Root Planing (SRP) in Conjunction With PerioWave, Compared to SRP Alone
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Decrease in Periodontal Pocket Depth
研究概览
简要总结
This study is to determine whether scaling and root planning (SRP) followed by photodynamic disinfection results in improved outcomes that persist over time in adults with chronic periodontitis when compared with subjects with SRP alone.
详细描述
Extensive research has shown that lethal photosensitization with low levels of laser light is an effective method of killing numerous types of organisms. This therapy avoids the use of antibiotics along with their potential side effects. The initial application of this therapy to the oral cavity is particularly appropriate since the therapy can be applied topically either in a specific or general fashion, killing is immediate and resistance is unlikely as it is free radical-mediated. In addition, the disease states being treated (gingivitis & periodontitis) are highly prevalent and associated with significant morbidity. The equipment and costs of this therapy are simple, easily applied and relatively inexpensive compared with current therapies. Based on the scientific data to date this therapy has the potential of significantly improving the oral health of those affected.
This is a pivotal, prospective, randomized, examiner blinded, multicenter study to evaluate the effect of a single treatment of photodynamic disinfection in adults with chronic periodontal disease.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is capable of giving informed consent
- •Subject is willing to sign a consent form
- •Adult male or female ≥ the age of 18
- •Having been diagnosed with chronic periodontitis
- •>18 fully erupted teeth
- •Has had no periodontal instrumentation in the four months prior to the initiation of study treatment
- •Subject has at least 4 sites with pocket depth of 6-9 mm in at least two quadrants of the mouth.
- •Subject is willing and able to return for treatment and evaluation procedures scheduled throughout the course of this clinical study
排除标准
- •Is pregnant or nursing or who plans to become pregnant in the next 4 months
- •Having significant liver disease by subject report
- •Having an active malignancy of any type by subject report
- •Having chronic disease or diminished mental capacity that would mitigate the ability to comply with the protocol
- •Having any significant chronic disease (either acute or chronic) with concomitant oral manifestations that in the opinion of the investigator would interfere with evaluation of safety or efficacy of PerioWave®
- •Having an active periapical abscess or periodontal abscess
- •Treatment with antibiotics with in the 1-month period prior to beginning the study or any systemic condition which requires antibiotic coverage for routine periodontal procedures (e.g. heart conditions, joint replacements, etc) by report of the subject
- •History of acute necrotizing ulcerative gingivitis
- •Known allergy to Methylene Blue
- •Has glucose-6-phosphate dehydrogenase (G6PD) deficiency by subject report
- •Currently uses anti-coagulant therapy at therapeutic doses
- •Currently uses photosensitizing medications
- •Participated in investigational treatment in the last 30 days or expectation for using a separate investigational treatment during the time of the study
结局指标
主要结局
Decrease in Periodontal Pocket Depth
时间窗: 6, 12, 24, 36, 48 weeks
次要结局
- Reduction in Bleeding on Probing(6, 12, 24, 36, 48 weeks)
- Increase in Clinical Attachment Level(6, 12, 24, 36, 48 weeks)