跳至主要内容
临床试验/CTRI/2024/04/065696
CTRI/2024/04/065696尚未招募4 期

The role of triamcinolone acetonide and hyaluronidase injection in minimizing labial scarring and improving peri-oral function following intraoral vestibular incisions.

Dr Shipra Bharti1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年4月28日最近更新:

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))

研究者

发起方
Dr Shipra Bharti
申办方类型
Other [self]

研究点 (1)

Loading locations...

相似试验