跳至主要内容
临床试验/CTRI/2021/05/033359
CTRI/2021/05/033359尚未招募不适用

Comparative assessment of post operative sequelae following surgical removal of mandibular third molar with and without extra-oral application of kinesiologic tape.

Sharad Pawar Dental College1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2021年10月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
15
试验地点
1
主要终点
Pain

研究概览

简要总结

Background -The surgical removal of impacted mandibular third molars produces a significant degree of trauma to the soft tissue and bony structures of the oral cavity, which can initiate significant inflammatory reaction. As a consequence of this, patient may experience several problems counting pain, facial edema, haemorrhage, alveolar osteitis, neural paraesthesia, and limited mouth opening due to muscle spasm in the post operative period. The taping begin started to be used in sports and musculoskeletal conditions with the focus to assist the injured soft tissues (muscles and joints) helping to reduce pain. Some of the recent researches have advocated the usage of KT is very useful and impactful management of postoperative complications of maxillofacial surgery

Objectives- The motive behind this research is to compare post-operative pain, swelling and trismus following third molar surgery in both test and control groups, whether theoretically based findings about KT can be implemented clinically as well.

Methodology - The research will be a prospective randomized control split-mouth non-blinded clinical study model to evaluate the impact of the KT on post-operative sequalae following surgical removal of mandibular third molar. With the cumulative 15 patients to be allocated for removal of bilateral involved mandibular third molar. The study will be done under two groups, Group A – Test group (KT) one side of patient’s face, subjected to beige tape application. Group B – Control group (No KT) other side of patient’s face, will be the controlled group without application of KT. Each patient will undergo 2 operative surgeries at 2 week-interval conducted by the same surgeon. Immediately after extraction extra-oral application of KT will be done for test group. The KT will be applied into 5 equal strips with approx. 1cm of width and will be applied between the tragus-commissure line and the clavicle. The patients will be evaluated for post-operative pain, swelling and trismus.

Expected Results - The use of kinesiologic tape will be effective in improvement of post-operative discomfort of the patient in the conditions of reduction of swelling, pain and trismus.

Conclusion- As kinesiologic taping originates from sports medicine, currently there are very limited evidence- based scientific studies for exploring KT application for treatment of post-operative edema in head and neck surgeries. This study will help to evaluate the use of KT enabling patients to experience a more comfortable postoperative period and helps them improving their quality of life. It may also reduce postoperative need for NSAID and analgesics, thus reducing the side effects associated with these drugs.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Age 18 years and above.
  • Impacted mandibular third molar indicated for extraction A medical history free of any systemic or pathological condition A medical history free of any pharmacological therapy able to introduce variables into the experiment.

排除标准

  • Patients not willing to be a part of the study Patients with uncontrolled systemic diseases Patients with incidence of skin lesions.
  • Patients reluctant to shave facial hair (for men).

结局指标

主要结局

Pain

时间窗: Day 1 | Day 2 | Day 3 | Day 7

Edema

时间窗: Day 1 | Day 2 | Day 3 | Day 7

Trismus

时间窗: Day 1 | Day 2 | Day 3 | Day 7

次要结局

  • Trismus(Day 1)

研究者

发起方
Sharad Pawar Dental College
申办方类型
Research institution and hospital

研究点 (1)

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