Evaluation of Combined Effect of Oral Premedications on Enhancing the Effectiveness of Inferior Alveolar Nerve Block in Mandibular Teeth With Symptomatic Irreversible Pulpitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Effectiveness of Inferior Alveolar Nerve Block (IANB
研究概览
简要总结
This clinical study investigates whether the combination of ibuprofen and serratiopeptidase as oral premedication can enhance the effectiveness of the inferior alveolar nerve block (IANB) in patients with symptomatic irreversible pulpitis in mandibular teeth. Due to the inflammatory nature of the condition, standard IANB often fails, possibly due to prostaglandin-induced nerve sensitization.
A total of 96 patients meeting specific inclusion criteria will be divided into four groups:
Placebo
Ibuprofen alone
Serratiopeptidase alone
Combination of ibuprofen and serratiopeptidase
Pain levels will be measured using the Verbal Numerical Scale (VNS) at various treatment stages. The success of anesthesia will be determined by the absence or presence of pain during access cavity preparation and initial root canal instrumentation. Statistical analysis will compare the effectiveness between groups, with the goal of determining whether combined premedication significantly improves IANB success.
The study is conducted at the Department of Operative Dentistry & Endodontics, HITEC-IMS Taxila, over a period of six months.
详细描述
Detailed Description of the Study Title Evaluation of Combined Effect of Oral Premedication on Enhancing the Effectiveness of Inferior Alveolar Nerve Block in Mandibular Teeth with Symptomatic Irreversible Pulpitis
Background and Rationale Achieving effective local anesthesia is a cornerstone of pain-free endodontic treatment. The inferior alveolar nerve block (IANB) is commonly used to anesthetize mandibular teeth. However, its success rate significantly drops in cases of symptomatic irreversible pulpitis, primarily due to inflammatory changes, nerve sensitization, and increased prostaglandin production. Prostaglandins, synthesized via the cyclooxygenase (COX-1 and COX-2) pathway, lower the pain threshold and reduce anesthetic efficacy.
Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen are widely used to reduce inflammation by inhibiting COX enzymes, thereby decreasing prostaglandin production. Several studies have shown that preoperative ibuprofen can enhance the effectiveness of IANB. However, other studies report conflicting results.
On the other hand, serratiopeptidase is a proteolytic enzyme known for its anti-inflammatory, mucolytic, fibrinolytic, and analgesic properties. It also acts on the COX pathway and reduces prostaglandin levels, offering a potentially synergistic effect with NSAIDs.
This study aims to evaluate the combined effect of ibuprofen and serratiopeptidase as premedication on improving the effectiveness of IANB in mandibular teeth with symptomatic irreversible pulpitis. To date, no published research has explored the combined preoperative use of these two agents for this purpose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group I - Placebo Group (Control)
Group I - Placebo:
Participants will receive an oral placebo capsule identical in appearance to the active medications, administered one hour before IANB, to serve as the control group for comparison of anesthetic effectiveness
干预措施: Patients in this group will receive an oral placebo (e.g., sugar tablet or inert capsule) 1 hour before the IANB (Dietary Supplement)
Group II - Ibuprofen Group
Group II - Ibuprofen:
Participants will receive a single oral dose of ibuprofen (400 mg) administered one hour prior to IANB to evaluate its effect on improving anesthetic success in symptomatic irreversible pulpitis
干预措施: Patients will receive ibuprofen (400-600 mg, standard therapeutic dose) orally, 1 hour prior to IANB (Drug)
Group III - Serratiopeptidase Group
Group III - Serratiopeptidase:
Participants will receive a single oral dose of serratiopeptidase (10 mg) one hour before IANB to assess its effect on enhancing anesthetic efficacy in symptomatic irreversible pulpitis
干预措施: Group III - Serratiopeptidase Group (Drug)
Group IV - Combination Group (Ibuprofen and Serratiopeptidase)
Group IV - Combination (Ibuprofen and Serratiopeptidase):
Participants will receive a single oral dose of ibuprofen (400 mg) and serratiopeptidase (10 mg) one hour before IANB to assess the combined effect on enhancing anesthetic success in symptomatic irreversible pulpitis
干预措施: Group IV - Combination Group (Ibuprofen and Serratiopeptidase) (Combination Product)
结局指标
主要结局
Effectiveness of Inferior Alveolar Nerve Block (IANB
时间窗: Time Frame: Perioperative
Effectiveness of Inferior Alveolar Nerve Block (IANB) Measured by the success rate of IANB in mandibular teeth with symptomatic irreversible pulpitis. Success is defined as: No pain or mild pain (VNS score 0-3) during: Access cavity preparation First file placement in the root canal Failure is defined as: Moderate to severe pain (VNS score 4-10) during the same stages. This will be compared among the four study groups (Placebo, Ibuprofen, Serratiopeptidase, and Combination therapy).
次要结局
未报告次要终点
研究者
Zahoor khan
Dr Zahoor khan BDS FCPS
HITEC-Institute of Medical Sciences