The role of triamcinolone acetonide and hyaluronidase injection in minimizing labial scarring and improving peri-oral function following intraoral vestibular incisions.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 2)Tissue fibrosis, by biochemical evaluation of serum lactate Dehydrogenase
研究概览
简要总结
Surgical procedures involving the maxillofacial skeleton require various incisions for exposure of surgical site. The most preferred approach is intra-oral, using a vestibular incision, for cosmetic reasons. However, this incision is associated with multiple complications such as infection, wound dehiscence, swelling, trismus and scarring. The fibrosis associated with vestibular incision specifically presents the following clinical problems; (1) impairment of normal lip movements (2) obliteration of vestibular depth which compromises prosthetic rehabilitationand (3) fibrotic bands especially in the anterior region, compromising the lower facial esthetics. Numerous methods have been employed to facilitate intraoral wound healing namely, cyano-acrylate based tissue adhesive, hyaluronic acid film, Pentoxifylline and injection of corticosteroids, hyaluronidase, & placentrix. However, there is a lacuna in literature regarding measures which prevent or minimize scarring associated with vestibular incision. The investigators of the study hypothesize that injection of triamcinolone acetonide & hyaluronic acid in the surgical site would reduce scarring associated with vestibular incision and improve lip function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients aged 20 to 50 years 2)Patients indicated for surgical procedures (orthognathic, trauma and pathology) requiring exposure of anterior maxilla or mandible by vestibular incision.
- •Patients categorized under ASA status I & II.
排除标准
- •Patients with lacerations or pathological changes in the lip 2)Patients with infection in the surgical site 3)Patients categorized under ASA status III, IV 4)Patients lesser then 20years and greater than 50years.
结局指标
主要结局
2)Tissue fibrosis, by biochemical evaluation of serum lactate Dehydrogenase
时间窗: 1)1st 3rd & 7th preoperative day & 2nd to 8th postoperative week | 2)Tissue fibrosis, by biochemical evaluation of serum lactate Dehydrogenase -preoperative and 8th postoperative week | 3)Tissue fibrosis by Ultrasonographic evaluation- preoperative and 8th postoperative week
3)Tissue fibrosis by Ultrasonographic evaluation
时间窗: 1)1st 3rd & 7th preoperative day & 2nd to 8th postoperative week | 2)Tissue fibrosis, by biochemical evaluation of serum lactate Dehydrogenase -preoperative and 8th postoperative week | 3)Tissue fibrosis by Ultrasonographic evaluation- preoperative and 8th postoperative week
1)Pain by clinical evaluation, using Numerical pain rating scale
时间窗: 1)1st 3rd & 7th preoperative day & 2nd to 8th postoperative week | 2)Tissue fibrosis, by biochemical evaluation of serum lactate Dehydrogenase -preoperative and 8th postoperative week | 3)Tissue fibrosis by Ultrasonographic evaluation- preoperative and 8th postoperative week
次要结局
- 1.Mouth opening in mm(2.Inter commissural distance (at rest, pursing & wide grin))
