Clinical Investigation of the Efficacy of CGF (Concentrated Growth Factor) and Ozone in the Treatment of Alveolar Osteitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in post-operative pain assessed: visual analog (VAS) scale
研究概览
简要总结
The aim of this study is to investigate the efficacy of CGF and Ozone in the treatment of alveolitis and to develop a new treatment protocol that can enable a quick and effective solution of this clinical problem, which significantly affects patients' comfort of life.
详细描述
In the present study, 60 healthy patients > 18 years old and have alveolitis, will included. 60 patient will divided randomly into three groups as Control, Ozone and Ozone+CGF. After irrigation of the sockets alvogyl, ozone and ozone+CGF will applied to the sockets respectively. Post operative pain, will measured at 1st to 7th days. Post operative infection, and granulation tissue will measured at 1st, 3rd and 7th days. Oral hygiene will evaluated at first visit. Quality of life will evaluated at 7th day.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who have one or more of the following in addition to severe pain, which occur within and around the socket 1-3 days after extraction and do not decrease with pain killers;
- •With a partially or completely disintegrated blood clot in the socket
- •With exposed bone that gives a dark gray appearance
- •With bad odor
排除标准
- •Who does not want to be volunteer for the study,
- •During pregnancy or lactation,
- •Has a chronic systemic disorder that will affect recovery,
- •Has hematological disorder
- •Cooperation cannot be established,
- •Previously received radiotherapy or chemotherapy,
- •Patients using oral contraceptives
结局指标
主要结局
Change in post-operative pain assessed: visual analog (VAS) scale
时间窗: 6th and 24th hour, 2nd day, 3rd day, 4th day, 5th day, 6th day and 7th day
For the evaluation of the pain, the visual analog scale (VAS) will be used to express the absence of pain in the initial part on a straight line (0) and the end part to express the unbearable pain (10). 0 (no pain)--------------------------------------------------------------------------------10 (unbearable pain) Higher values of the scale represent worse outcome.
次要结局
- Inflamation severity(postoperative 1st, 3rd, 7th days)
- Granulation tissue health(postoperative 1st, 3rd, 7th days)
- Change in the quality of postoperative life after the procedures performed(postoperative 7th day)
研究者
Dr. Damla Torul
Associate Professor
T.C. ORDU ÜNİVERSİTESİ