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
- 1
- 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
研究组 & 干预措施
Control Group
extraction of the lower third molar will be performed according to the standard protocols of the structure
Trial Group
In this group ozone will be used, 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 the therapeutic scheme prescribed at the time of resignation
干预措施: ozone therapy (Other)
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