An Evaluation of the Effect of the Erchonia Corporation FX-405 Laser as an Adjunctive Treatment of Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- Number of participants with a change in Clinical Attachment Loss of ≥-2mm at the primary tooth assessment site
研究概览
简要总结
The purpose of this clinical study is to determine the effectiveness of the Erchonia® FX-405 (manufactured by Erchonia Corporation (the Company) in providing a noninvasive adjunctive treatment in combination with periodontal scaling and root planing for improving the treatment of periodontal disease.
详细描述
The purpose of this clinical study is to determine the effectiveness of the Erchonia® FX-405 (manufactured by Erchonia Corporation (the Company) in providing a noninvasive adjunctive treatment in combination with periodontal scaling and root planing for improving the treatment of periodontal disease. This clinical study is a double-blind design, such that neither the subject, nor the investigators - the investigator administering the treatment with the Erchonia® FX-405™ device (administration investigator) or the investigator recording the outcome measures (assessment investigator) - will be aware of whether the subject has been assigned to the active treatment test group or to the sham treatment control group until after the study is complete. All study subjects, regardless of treatment group assignment will receive active scaling and root planing standard of care therapy in addition to the active or sham therapy with the Erchonia® FX-405™ device.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has voluntarily signed a written informed consent form.
- •Male or female 22 to 75 years of age, inclusive.
- •Subject has no evidence of Localized Aggressive Periodontitis.
- •Tooth loss due to periodontitis of ≤ 4 teeth.
- •Two or more teeth with the following characteristics: Non 3rd molar, Periodontitis: Stage III (Severity) according to the Interdental CAL (at site of greatest loss) and RBL, as classified by the American Academy of Periodontology (AAP), No evidence of caries, No abscess infection, No previous periodontal surgery within the prior 12 months
- •Subject agrees to adhere to study provided home care instructions to maintain adequate oral hygiene during the study duration.
- •Subject agrees to refrain from the use of smokeless chewing tobacco for the study duration.
- •Subject agrees to refrain from exceeding 40 milligrams per day of inhaled nicotine, encompassing cigarettes, electronic cigarettes, and cigars.
- •Subject agrees to refrain from engaging in any other treatments for his or her periodontitis that is outside the scope of this study during his or her participation in this study
排除标准
- •Gingival recession which may be genetic, induced secondary to orthodontic treatment, induced secondary to frenulum attachments, or present as a result of dental malocclusion.
- •History of oral cancer or HIV in the last 6 months
- •Pregnant or intending to become pregnant in the next 8 months.
- •Sensitivity to, or contraindication for, light therapy.
- •Currently enrolled in a clinical study of an investigational drug or device.
研究组 & 干预措施
Erchonia® FX405
The Erchonia® FX405 is made up of (3) 6405 nanometers red laser diodes and (1) 405 nanometers violet laser diode mounted in a robotic scanner device.
干预措施: Erchonia® FX405 (Device)
Placebo Laser
The Placebo Laser has the same appearance as the Erchonia® FX405 but does not emit any therapeutic light.
干预措施: Placebo Laser (Device)
结局指标
主要结局
Number of participants with a change in Clinical Attachment Loss of ≥-2mm at the primary tooth assessment site
时间窗: Baseline and 8 months
The Clinical Attachment Loss (CAL) from baseline to endpoint (8 months) measurement is calculated for each subject. Individual subject success is defined as a 2mm or greater change in CAL at the primary tooth assessment site across the evaluation period. A negative (-) change indicates a reduction in periodontitis and is positive for individual subject success. A lower CAL score from baseline to study endpoint represents a better outcome, whereas a higher score from baseline to study endpoint represents a worse outcome.
次要结局
未报告次要终点