Effects of the Application of a Hyper-oxygenated Gel After Extraction of Impacted Lower Third Molars: Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Masseteric trismus.
研究概览
简要总结
The goal of this clinical trial is to evaluate whether the topical application of Novox® Drop on surgical wounds after the extraction of lower third molars can have a clinical advantage.
The primary objective of the study is to evaluate the possible reduction of masseteric trismus (masticatory muscle spasm - primary outcome) and of post-operative pain and facial edema (swelling - secondary outcomes) after the extraction of impacted third molars compared to those who do not use it (placebo=glycerin-based gel).
详细描述
Novox drop is a medical device (CE certified, class II b, non-invasive) based on oxygen-enriched olive oil (Excipients: Mint essential oil (2%), Stevia extract (1%)). Mechanism of action: facilitate the healing process by creating, thanks to the release of reactive oxygen species (ROS), a microenvironment favorable to the activation of the microcirculation and at the same time unfavorable to the proliferation of pathogens. Furthermore, it has a film-forming, protective, barrier and soothing action thanks to its oily nature.
The placebo consists of a viscous, colorless and transparent gel, based on glycerin (Conformity:FUI).
The company producing Novox Drop will package both gels in opaque disposable syringes, identical from each other and distinguishable only by the presence of an "A" or "B" code. During the phases of the study, only the company will be aware which of the two codes will be associated with the medical device and which will be associated with the placebo. The patients to be subjected to the study will be obtained from those arriving at the maxillofacial surgery clinics for the surgical extraction of complex lower third molars, starting from July 2024 until the necessary sample size of 72 participants is reached. Each of them, who will be assigned a sequential numerical code, will be placed randomly (randomized) in one of the two arms of the study itself, group A or group B, using the Excel Microsoft 2015 system.
Patients in group A, in addition to the standard antibiotic therapy (amoxicillin + clavulanic acid 1 g x 3 times a day x 7 days) and painkiller (paracetamol 1000 mg x 2 times a day x 7 days) will be prescribed the home use of syringe A. Patients in group B, in addition to the aforementioned traditional therapy, the syringe B. The gel prescribed in both groups must be applied to the post-extraction site 3 times a day for 7 days. Furthermore, after each application of the gels, the patient cannot consume drinks and solid foods for 30 minutes.
The duration of the study will be one week, and will be divided into three visits:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •good systemic and local health conditions of the patient;
- •age between 18 and 35 years;
- •understanding of the Italian language,
- •indications for the extraction of impacted bilateral lower third molars (38 and 48) according to the criteria reported in the classifications of Winter and that of Pell and Gregory;
- •the root of the impacted third molars is completely formed.
排除标准
- •diabetes mellitus;
- •systemic arterial hypertension;
- •hyperthyroidism;
- •osteoporosis;
- •immunosuppressed;
- •osteonecrosis of the jaws;
- •pregnancy;
- •patients with mandibular third molars in position C according to "the Pell & Gregory Classification" on the radiological measurements (angles and positions) for which third molar extraction surgery is required.;
- •local alterations such as pericoronitis, odontogenic cysts and tumors in relation to the third molars;
- •allergies;
- •ordinary use of analgesics or antibiotics by the patient.
研究组 & 干预措施
Hyper-oxygenated Gel
Patients undergoing lower third molar extraction. Post-operatively, the antibiotic (amoxicillin + clavulanic acid) and the painkiller (paracetamol 1000mg x 2 times a day x 7 days) are prescribed.
Furthermore, patients will have to use the Novox drop at the post-extraction site 3 times a day for 7 days (without taking liquids for 30 minutes after use).
干预措施: Hyper-oxygenated gel (Other)
Placebo
Patients undergoing lower third molar extraction. Post-operatively, the antibiotic (amoxicillin + clavulanic acid) and the painkiller (paracetamol 1000 mg x 2 times a day x 7 days) are prescribed.
Furthermore, patients will have to use the Placebo, glycerin based gel, at the post-extraction site 3 times a day for 7 days (without taking liquids for 30 minutes after use).
干预措施: glycerin based gel (Other)
结局指标
主要结局
Masseteric trismus.
时间窗: seven days
Masseteric trismus will be assessed by measuring the width of the mouth opening. Precisely, the distance in cm between the mesial corners of the incisal edges of the upper central incisors and the lower right incisors at maximum mouth opening, before surgery and on the seventh postoperative day, using a caliper. Measurements will be taken twice to determine the average score. The difference between the average of each postoperative measurement and the preoperative one will indicate the trismus for that day.
次要结局
- Post-operative pain(seven days)
- Facial swelling(seven days)
研究者
Mitro Valeria
Principal Investigator
Azienda Ospedaliera di Perugia