Comparison of clinical efficacy of Benzydamine Hydrochloride oral rinses versus normal saline rinses to satisfy analgesic requirements post orthodontic premolar extraction - A comparative split mouth study.
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- VAS score maybe lower and satisfaction level may be higher as compared to control group.
研究概览
简要总结
Oral surgeons have been most commonly using oral non-steroidal anti-inflammatory drugs (NSAIDs) to manage postoperative discomfort
However, the use of oral NSAIDs have been associated with numerous gastrointestinal, renal and hematological side effects.
Efficient, safe and topical medications with anti-inflammatory action and minimal side-effects would be a good option for controlling pain after removal of premolars for orthodontic treatments.
Benzydamine hydrochloride {1-benzyl-3-[3(dimethylamino)-propoxy]-1H-indazole hydrochloride} is a non-steroidal drug with anti-inflammatory, analgesic, and anti-microbial properties. It exerts the effect by forming thromboxanes which decreases prostaglandin production.
The aim of this study is to compare the clinical efficacy of Benzydamine Hydrochloride oral rinse with that of normal saline rinses on pain and patient satisfaction after removal of bilateral premolars for orthodontic correction of malocclusion.
Topical NSAID benzydamine hydrochloride may reduce the use of oral analgesic consumption as compared to the use of normal saline gargle. The satisfaction level after using benzydamine hydrochloride would be better as that after using normal saline gargle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Bilateral premolar extraction advised by Dept of Orthodontics.
- •2.Extraction site should be free of active infection.
- •3.Atraumatic extraction.
- •4.Patient should be free of drug reaction used in our study (allergy).
- •5.Patient should be free of any co-morbidity.
排除标准
- •1.Known mentally challenged patients and patients unable to communicate.
- •2.Patients with known systemic co-morbidity.
- •3.Fracture of tooth during extraction.
- •4.Presence of active infection.
结局指标
主要结局
VAS score maybe lower and satisfaction level may be higher as compared to control group.
时间窗: Patient will be followed up on 3rd day post extraction
次要结局
- VAS score maybe lower & satisfaction level may be higher as compared to scores on 3rd day post extraction.(Patient will be followed up on 7th day post extraction)
研究者
Dr Nupoor Sanjaykumar Meher
Bharati Vidyapeeth Dental College and Hospital, Pune