Comparative Efficacy Of Pre-Emptive Use Of Enzyme & Anti-Oxidant Based NSAID Over Plain NSAID On Inferior Alveolar Nerve Blockade And Postoperative Pain Control In Endodontic Treatment Of Molars With Symptomatic Pulpitis: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- To compare and evaluate the efficacy of the Enzyme and Antioxidant based NSAID as preoperative medication on the success of Inferior Alveolar Nerve Block.
研究概览
简要总结
Pain management during and after endodontic treatment is essential for both clinicians and patients. Thus, effective anesthesia and minimal postoperative pain is always considered to be of utmost importance during an endodontic treatment.
Inferior alveolar nerve block (IANB) is preferred anesthetic technique for endodontic treatment of mandibular molars. However, success rate of IANB is quite low in patients with symptomatic irreversible pulpitis (SIP) in mandibular molars, ranging from 58% to 79%. Anesthetizing tooth with irreversible pulpitis poses a challenge as the voltage-gated sodium channels are resistant to local anesthetic relatively. Anatomical variations, pulpal inflammation, failure of anesthetic technique and even anxiety caused by preoperative pain can explain anesthetic difficulty.
In postoperative period following an endodontic procedure, approximately 47% of patients report moderate to severe pain, with a higher incidence between 6 and 24 h. The inflammatory process of the pulp involves pro-inflammatory chemical mediators, mainly prostaglandins, which have been shown to cause hyper-algesic effects in addition to inflammatory process. Although periapical inflammation has a significant influence on occurrence of postoperative pain, the presence of excruciating symptoms in preoperative period is one of the factors that can contribute to an increase in pain score.
This study is an attempt to check whether additional factors like Bromelain, Trypsin (ENZYMES) and Rutoside trihydrate (ANTIOXIDANT) provide a synergistic action to the NSAID in pain control which indirectly provides its efficacy over nerve blockade.
In the literature we have many studies proving the potency of various NSAIDs over the IANB success and postoperative pain, but there is a paucity of studies investigating an enzyme and antioxidant based NSAID’s efficacy over IANB success and pain control in endodontically treated molars, which forms the basis of this study research.
The aim of the study is to compare and evaluate the efficacy of the Enzyme and Antioxidant based NSAID (Bromelain 90mg, rutoside trihydrate 100mg, trypsin 48mg, diclofenac sodium 50mg) and plain NSAID (Diclofenac sodium 50mg) as preoperative medication which is given 60 min before initiating the endodontic treatment and to assess its effect on the success of Inferior Alveolar Nerve Block, and to evaluate the influence of these drugs on the intensity of pain during the procedure and postoperative pain at 4 intervals i.e. 6, 12, 24 and 48 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •Mandibular molars diagnosed with Symptomatic Irreversible Pulpitis and Apical Periodontitis.
- •Had not taken any type of analgesic medication within the previous 12 h.
- •The absence of periapical radiolucency on radiographs, except for a widened periodontal ligament.
排除标准
- •Patients allergic to diclofenac, bromelain, rutoside, trypsin, lidocaine or any other medication/ material used in study.
- •Diabetic, Hypertensive, Smoking, Pregnant or lactating women.
- •Any endocrine or infectious disease or had any systemic disease that contraindicate endodontic therapy.
- •Teeth with periodontal disease, necrotic tooth.
- •Radiographic images suggestive of internal or external resorptions.
- •Endodontic treatments not completed in a single session.
- •Failed to achieve adequate anesthesia (IANB).
结局指标
主要结局
To compare and evaluate the efficacy of the Enzyme and Antioxidant based NSAID as preoperative medication on the success of Inferior Alveolar Nerve Block.
时间窗: NRS pain scale scored from 0 to 10, taken 15 minutes after the Inferior Alveolar Nerve Block.
次要结局
- To compare and evaluate the influence of the Enzyme and Antioxidant based NSAID as preoperative medication on the intensity of pain during the procedure and postoperative pain at 4 intervals i.e. at 6, 12, 24 and 48 hours.
研究者
Dr S Srija Mili
MALLA REDDY DENTAL COLLEGE FOR WOMEN
