Clinical and Microbiologic Outcomes of Adjunctive Antimicrobial Photodynamic Therapy in the Non-surgical and Surgical Treatment of Teeth With Periodontal Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Number of Bleeding Sites (Bleeding On Probing)
研究概览
简要总结
The purpose of this study is to compare clinical outcomes after mechanical debridement of at sites exhibiting plaque induced inflammation with or without adjunctive Antimicrobial photodynamic therapy (aPDT) and to assess the the microbiologic profile before and after treatment with or without aPDT
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 (Participant)
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
- •One pocket on each side of the mouth (split design)
- •Single rooted tooth
- •Pocket depths measured greater than 4mm with bleeding on probing
- •Horizontal bone loss
- •No furcation involvement
排除标准
- •current heavy smokers (>10 cigarettes/day)
- •have uncontrolled diabetes (HbA1c ≥ 6.5%)
- •other uncontrolled systemic diseases that may comprise healing, such as Vitamin C deficiency, any neutrophil deficiencies, immunodeficiency syndromes, or leukemia
- •taking antibiotics within 3 months before the procedure
- •vertical bone defects that requires surgical regenerative treatment.
- •Pregnancy
研究组 & 干预措施
mechanical debridement and adjunctive aPDT
干预措施: mechanical debridement (Device)
mechanical debridement and adjunctive aPDT
干预措施: adjunctive aPDT (Device)
mechanical debridement and sham aPDT
干预措施: mechanical debridement (Device)
mechanical debridement and sham aPDT
干预措施: sham aPDT (Device)
结局指标
主要结局
Change in Number of Bleeding Sites (Bleeding On Probing)
时间窗: baseline, at the re-evaluation appointment(4 to 6 weeks after baseline)
Bleeding on probing will be evaluated by gently sweeping the periodontal probe just within the gingival sulcus of the tooth and the presence or absence of bleeding will be recorded .The change is reported as \[(number of bleeding sites (bleeding on probing) at the re-evaluation appointment(4 to 6 weeks after baseline) - (number of bleeding sites (bleeding on probing) at baseline)\] - a negative value indicated less bleeding sites.
Change in Number of Bleeding Sites (Bleeding On Probing)
时间窗: baseline, 3 months after baseline
Bleeding on probing will be evaluated by gently sweeping the periodontal probe just within the gingival sulcus of the tooth and the presence or absence of bleeding will be recorded. The change is reported as \[(number of bleeding sites (bleeding on probing) at 3 months after baseline) - (number of bleeding sites (bleeding on probing) at baseline)\] - a negative value indicated less bleeding sites.
Change in Probing Depth (Periodontal Pocket Depth )
时间窗: baseline, at the re-evaluation appointment (4 to 6 weeks after baseline)
Periodontal pocket depth is measured from the free gingival margin to the base of the pocket, with a UNC periodontal probe with 1mm measurement units. The change is reported as \[Periodontal pocket depth at the re-evaluation appointment(4 to 6 weeks after baseline) - (Periodontal pocket depth at baseline)\] - a negative value indicates a reduction in pocket depth
Change in Probing Depth (Periodontal Pocket Depth )
时间窗: baseline, 3 months after baseline
Periodontal pocket depth is measured from the free gingival margin to the base of the pocket, with a UNC periodontal probe with 1mm measurement units. The change is reported as \[(Periodontal pocket depth at 3 months after baseline) - (Periodontal pocket depth at baseline)\] - a negative value indicates a reduction in pocket depth
次要结局
- Microbiologic Profile of Plaque as Indicated by Percent of Total Abundance of 4 Oral Bacterial Complexes(baseline)
- Microbiologic Profile of Plaque as Indicated by Percent of Total Abundance of 4 Oral Bacterial Complexes(at the re-evaluation appointment (4 to 6 weeks after baseline))
- Microbiologic Profile of Plaque as Indicated by Percent of Total Abundance of 4 Oral Bacterial Complexes(3 months after the debridement (3 months after baseline))
- Change in Microbiologic Profile of Gingival Crevicular Fluid(GCF)(baseline, at the re-evaluation appointment (4 to 6 weeks after baseline), and 3 months after baseline)
研究者
Jennifer Chang
Associate Professor
The University of Texas Health Science Center, Houston