Effect of Photodynamic Therapy on Soft Tissue Healing After Tooth Extraction at Sites of Periodontal Infection: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Wound healing rate at 7 days
研究概览
简要总结
Main Purpose: To evaluate the effect of photodynamic therapy on soft tissue healing after tooth extraction at periodontal infection site, and to compare the effect on pain degree and bone tissue remodeling after tooth extraction.
详细描述
The aim of this study is to evaluate the effect of photodynamic therapy (PDT) on soft tissue healing and bone remodeling in tooth extraction sockets after tooth extraction. The enrolled patients will be randomized into two groups. The control group used conventional tooth extraction to clean the wound, and the experimental group used photodynamic therapy to help clean the wound. Seven days and 14 days after extraction, the area of extraction socket was measured, the healing rate of extraction socket was calculated, and Landry, Turnbull and Howley soft tissue healing index was measured. The degree of pain was recorded at 6h, 1 day, 2 days and 3 days after tooth extraction. Bone remodeling indexes were measured at 1 month after tooth extraction.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range from 18 to 65 years old;
- •Patients with extensive periodontitis of the whole mouth;
- •There was a deep periodontal pocket with PD≥5mm and at least one adjacent tooth at the extraction site;
- •Periodontitis was controlled, and the extraction site and adjacent teeth were not in the acute inflammation or infection stage;
- •The extraction site has a hopeless prognosis or no preservation value, and it is the first and second molars or maxillary wisdom teeth that erupt in a positive position
排除标准
- •pregnant and lactating women;
- •patients with systemic diseases that may affect the ability of postoperative healing (such as patients with radiotherapy and chemotherapy, history of hematological diseases, and uncontrolled disease) Diabetes mellitus, etc.);
- •long-term use of drugs known to affect bone metabolism or mucosal healing such as bisphosphonates and non-steroidal anti-inflammatory drugs;
- •smoking > 10 cigarettes per day;
- •root breakage or gingival tear occurred during tooth extraction.
研究组 & 干预措施
Experimental group
Debridement of tooth extraction sockets was assisted by photodynamic equipment
干预措施: Dental diode laser device Paiwei™（Zhengzhou Gata biotechnology Co.,Ltd.,China） which was 650-670nm with a power of 160mw-220mw. (Drug)
结局指标
主要结局
Wound healing rate at 7 days
时间窗: baseline;at 7 days
（The size of the tooth extraction wound area at 7 days）/(The size of the tooth extraction wound area at baseline)
次要结局
- Changes in Bone Mineral density(baseline, at 1 month)
- Landry, Turnbull and Howley soft tissue healing index(baseline, at 7 days; at 14days)
- Degree of pain(at 6 hours; at 1 day; at 2 days; at 3 days)
- Bone height changes(baseline, at 1 month)
- Wound healing rate at 14 days(baseline;at 14 days)
研究者
Peihui Ding
Principal Investigator
The Dental Hospital of Zhejiang University School of Medicine