Evaluation of Hyaluronidase Vs Dexamethasone Submucosal Injections in Reducing Post Operative Sequalae after Disimpaction of Bilateral Impacted Mandibular Third Molar - A Split Mouth Study
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Post operative pain, mouth opening and swelling
研究概览
简要总结
Aim of the proposal:
To evaluate the efficacy of submucosal Hyaluronidase vs Dexamethasone injections in reducing postoperative sequalae like Pain, Mouth opening and Swelling after disimpaction of bilateral mandibular third molar.
Specific Objectives:
To assess and compare the effectiveness of Hyaluronidase and Dexamethasone in post- operative pain control.
2) To assess and compare the effectiveness of Hyaluronidase and Dexamethasone in Mouth opening.
3) To assess and compare the effectiveness of Hyaluronidase and Dexamethasone in reducing facial swelling.
Materials &Methods:
Source & Selection of Samples:
The present study will be conducted in the department of oral and maxillofacial surgery. 44 patients who met with inclusion criteria will be selected from out-patient department of oral and maxillofacial surgery.
Summary :
Patients reporting to the department of oral and maxillo-Facial Surgery during the study period (Duration-18 months) for bilateral mandibular third molar surgery are included based on inclusion criteria,.Study will be explained & written informed consent will be taken, Randomization is done alternatively into two groups, Group-1 Administration of submucosal Hyaluronidase inj(1500 IU) at surgical site(mesial,distal and buccal) 1ml after Surgical procedure is done under local Anaesthesia and flap closure with silk sutures. Group-2 Administration of submucosal Dexamethasone inj (4mg) at surgical site site(mesial,distal and buccal) 1ml after Surgical procedure is done under local Anaesthesia and flap closure with silk sutures. Pain, Mouth opening and Facial swelling will be measured Pre-operative and compared with post-operative day 3 & day 7 & day 14. 1) The Pain score will be assessed using Visual Analog scale 2) Mouth opening measured with Digital Vernier calipers. 3) Facial swelling measured with measuring thread as three linear measurements.a) Tragus – Oral commissure b) Tragus – Pogonion c) Lateral Canthus - Gonion. All the 3 linear measurements are summed up and calculated.
**Statistical test:**1) Repeated measures of ANOVA at different time intervals : To calculate the outcome variables in the two groups and comparison between the groups. 2) Mann Whitney test for measuring Pain with Visual Analog scale.3) Independent sample T test for comparing differences between Pre-operative, Post-operative day-3 ,day-7 and day-14. Results and interpretation of data is done.
OUTCOME: post-operative complications like pain, mouth opening and swelling will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 44.00 Year(s)（—）
- 性别
- All
入选标准
- •Age group 18-40 years Healthy and Non-Diabetic patients.
- •Patients falling under physical status classification (American society of Anesthesiologists) ASA 1 and ASA 2 individuals Compliance with the study following voluntary participation.
- •Patients with similar class of Bilateral Impacted Mandibular molar teeth (mesioangular, class-1,position A or B).
排除标准
- •History of adverse effects to any drugs to be administered during the study period.
- •Pregnant or lactating woman.
- •Long-term use of drugs that affect systemic inflammatory response.
- •Patients who are not willing to be involved in the study.
结局指标
主要结局
Post operative pain, mouth opening and swelling
时间窗: Pre operative day 1, post operative days 3rd, 7th ,14th day
次要结局
- No Secondary outcome measured .Any adverse events will be noted(Pre operative day 1, post operative days 3rd, 7th ,14th day)
研究者
Edara Samuel
Dr.Ntr university of health sciences