Clinical Evaluation of WaterLase (iPlus) Laser Therapy Used as an Adjunct to Non-Surgical Treatment of Chronic Periodontitis: A Randomized, Controlled, Split-Mouth Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 主要终点
- Probing Pocket Depth
研究概览
简要总结
The use of lasers to treat various problems in dentistry is growing as it has in medicine. One application is the use of lasers to treat periodontal disease. It has been suggested that the laser may reduce the need for surgical treatment by reducing pockets. The goal of this study is to evaluate the effectiveness of laser treatment for periodontal disease. Laser therapy will be used in addition to traditional non-surgical scaling and root planing (deep cleaning). The information obtained from this study will provide an objective assessment of adjunctive laser therapy compared to conventional periodontal therapy and will attempt to show the benefits, if any, lasers can provide in the treatment of 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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 years old or older (male or female)
- •Healthy without systemic diseases that may adversely effect healing
- •Not pregnant and no current plans to become pregnant
- •No periodontal treatment in the previous 12 months
- •No systemic antibiotic therapy in the previous 6 months
- •At least two quadrants with periodontitis (ideally opposite side same jaw)
- •Each quadrant must have two or more sites with probing pocket depths ≥ 5mm
- •Each quadrant should include interproximal intrabony defect(s)
- •Exclusion criteria:
- •Any systemic disease, medication, or habit known to adversely influence bone metabolism and/or wound healing:
- •Poorly controlled diabetes (HbA1c > 7%)
- •History of bisphosphonate medications
- •History of radiation therapy affecting the proposed treatment site(s)
- •History of immunosuppressive medications (e.g. corticosteroids)
- •History of tobacco use (current or past tobacco use within the past 1 year)
- •Immune compromise caused by disease, treatment or other condition
- •Recent history of periodontal surgery (within the previous 2 years)
- •Recent history of scaling and root planing (within the previous 12 months)
- •Any condition that contraindicates periodontal therapy including surgery
排除标准
- 未提供
结局指标
主要结局
Probing Pocket Depth
时间窗: 12 months
This is a measure from base of pocket to gingival margin.
Sites That Bleed on Probing
时间窗: 12 months
Percentage of sites that bleed in response to probing. Bleeding observed within 30 seconds from pocket/sulcus following periodontal probe measurement.
Gingival Recession
时间窗: 12 months
Measure of gingival recession following treatment. This is a measure of the gingival margin from the cement-enamel junction.
Clinical Attachment Level
时间窗: 12 months
Periodontal clinical attachment level following treatment. This is a calculation (clinical attachment level = probing pocket depth + gingival recession).
次要结局
- Periodontal Microbiome(12 months)
- Patient Reported Outcomes: VAS Questionnaire(12 months)
研究者
Perry R Klokkevold, DDS, MS
Professor of Clinical Dentistry
University of California, Los Angeles