Influence of Ozone Therapy on Postoperative Pain Relief in the Surgical Treatment of Lower Third Molars: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Reduction post operative pain
研究概览
简要总结
Patients will undergo a split-mouth protocol which includes:
a control group: in which the extraction of the lower third molar will be performed according to the standard protocols of the structure.
A study group: in which ozone will be used in addition, in two formulations: gaseous, injected into the site of the pre- and post-surgery operation, and topical, in the form of a gel, applied at the end of the operation and for home use according to therapeutic scheme prescribed at the time of discharge.
Primary objective: To evaluate whether the use of ozone in patients undergoing extraction of impacted third molars reduces post-operative pain 7 days after surgery.
Secondary objectives:
- Evaluate the functional limitation in opening the mouth (trismus) 7 days after surgery.
- Evaluate if there is a reduced intake of analgesic drugs in the 7 days following the operation.
- Evaluate the perceived quality of life in the 7 days following the intervention.
详细描述
Patients will undergo a split-mouth protocol which includes:
a control group: in which the extraction of the lower third molar will be performed according to the standard protocols of the structure.
A study group: in which ozone will be used in addition, in two formulations: gaseous, injected into the site of the pre- and post-surgery operation, and topical, in the form of a gel, applied at the end of the operation and for home use according to therapeutic scheme prescribed at the time of discharge.
Primary objective: To evaluate whether the use of ozone in patients undergoing extraction of impacted third molars reduces post-operative pain 7 days after surgery.
Secondary objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lower third molars included
- •Pell-Gregory Class II-B
- •Absence of systemic diseases
排除标准
- •Hyperthyroidism;
- •G6PHD (glucose 6 phosphate dehydrogenase) deficiency;
- •Myasthenia
- •Pregnancy and breastfeeding
- •Allergy to ozone
- •Local infections
结局指标
主要结局
Reduction post operative pain
时间窗: 7 days
Evaluate whether the use of ozone in patients undergoing extraction of impacted third molars reduces post-operative pain 7 days after surgery.
次要结局
未报告次要终点