Assessment of Healing Properties Using Hyaluronic Acid Topical Application in Parasymphyseal Fracture Fixation: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 22
- 主要终点
- Patient satisfaction(score)
研究概览
简要总结
HA is favorable for osteogenesis, enhancing bone growth, acting a vector for osteoinductive compounds and promoting even distribution and increased density of newly formed bone, thereby altering the scaffold morphology and improving mineralization. In this study 22 volunteers will be included in this study, the volunteers will be randomly distributed into two groups each containing 11 volunteers, one group will be treated by hyaluronic acid before fixation and the other group will be treated by fixation only without placement of hyaluronic acid, to compensate for drop out 13 volunteers per group
详细描述
Patients of both groups will be subjected to:
- Clinical assessment including case history including personal data,medical,surgical history and family history
- Radiographic assessment includes preoperative digital panomora to evaluate fracture and to conclude presence or absence of any foreign body or pathological pathosis.
- Signing the informed consent will be done after explaining surgical procedure. All the patients will be nasally intubated, scrubbed and draped in the standard manner, followed by intra-oral and extra-oral povidone-iodine (Betadine)swabbing.
Local anesthesia containing vasoconstrictor will be injected in the vestibule Incision at lower anteriors will be done in the mucosa in a curvilinear fashion 10-15mm away from the attached gingiva, the incision distal to the canine will be 5 mm from the attached gingival to be superior to the mental nerve.
Submucosal dissection will be done to expose the mentalis muscle, followed by mucoperiosteal flap elevation till inferior border exposing the fracture line.
The fracture segments will be reduced after curettage and removal of any debris.
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)
盲法说明
Double(Participant, Outcome Assessor)
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with unilateral Para symphyseal fracture
- •Systemically healthy patients (American Society of Anesthesiologists -ASA I and II)
- •Age of the patient above 16 years to 60 years old
- •Patient of both sexes
- •Patients willing for the surgical procedure and follow up with an informed consent.
排除标准
- •Bad oral hygiene
- •smokers (>10cigarettes/day)
- •Existence of a bone metabolic disease; currently taking drugs that might influence bone metabolism
- •Radiotherapy or chemotherapy form malignancy
- •Patients who refused to sign consent form
结局指标
主要结局
Patient satisfaction(score)
时间窗: at one week and three months intervals
Patient satisfaction survey through score
次要结局
- Fracture gap distance(mm)(immediate postoperative and four months intervals)
研究者
aisha khaled mansour
principal investigator
Cairo University