Efficacy of Arnica Montana for evaluation of pain , swelling and trismus followed by extraction of impacted mandibular third molar surgery
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To measure the decrease in pain, swelling and trismus
研究概览
简要总结
Aim of this study is to evaluate the clinical efficacy of Arnica Montana (AM) in reduction following extraction of impacted mandibular 3rd molars
To evaluate swelling, pain and trismus post extraction after receiving Arnica montana tablets orally post surgical extraction of impacted third molar
Duration of study : 18 months
Each patient will undergo surgical removal of mandibular third molar under local anaesthesia.
Group A : Control group – Will be recieving Antibiotics- Amoxicillin 500mg/3 times a day, Analgesic- Paracetamol 500mg/ 3 times a day , Antacid -Pantoprazole 40 mg / once a day before breakfast
Group B: Study group – Arnica Montana tablets (sublingually)
(1) 4 tablets 1 hour before the procedure (Day 0);
(2) 4 tablets×4 times/day starting 1 hour following extraction of mandibular 3rd molar ( Day 0 -total 16 tablets)
(3) 4 tablets×4 times/day on Day 1 (total of 16 tablets)
(4) 4 tablets×4 times/day on Day 2 (total of 16 tablets)
(5) 4 tablets×4 times/day on Day 3 (total of 16 tablets)
Along with Arnica Montana they will also be prescribed antibiotics- amoxicillin 500mg/3 times a day, analgesic- paracetamol 500mg/ 3 times a day , antacid -pantoprazole 40 mg / once a day before breakfast
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients in between the age group 18 to 45 years.
- •Impacted mandibular 3rd molar with classes I and II surgical difficulty and depth level of A or B indicated for extraction based on Pell-Gregory classification
- •Patient willing for participation in study.
- •No recent history of using NSAIDs or corticosteroids in last 2 weeks.
- •No known underlying medical condition which may affect the outcome.
排除标准
- •Patient with contraindication to Arnica Montana therapy such as pregnant and breastfeeding women.
- •No active smoking of any type
- •Known allergy to Arnica Montana
- •Medically compromised patients.
结局指标
主要结局
To measure the decrease in pain, swelling and trismus
时间窗: day 1, day 3 day 7
次要结局
- faster reduction of pain ,swelling and trismus after giving Arnica Montana along with NSAID(day 1, day 3 day 7)
研究者
Dr. Revati Naidu
School of Dental Sciences ,Krishna Vishwa Vidyapeeth