Evaluation of the Effect of Intra-ligamentary Injection of Diclofenac Potassium Versus Articaine on Anaesthetic Efficacy in Mandibular Molars With Symptomatic Irreversible Pulpitis:A Randomized Controlled Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Efficacy of local anesthesia
研究概览
简要总结
This study aims to assess the effect the intraligamentary injection of Diclofenac Potassium versus Articaine 4% on the anaesthetic efficacy & intensity of intraoperative & postoperative pain during single visit root canal treatment in patients with symptomatic irreversible pulpitis in mandibular molar teeth
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy patient (ASA I or II).
- •Mandibular Posterior teeth with:
- •Preoperative sharp pain, Absence or slight widening in the periodontal ligament (PDL), Vital response of pulp tissue to cold pulp test.
- •patients who agree to provide written consent and the patients able to understand the pain scale and attend for recall appointments
排除标准
- •Patients allergic to anesthetic solutions & other NSAIDs.
- •Pregnant or nursing females.
- •Patients having significant systemic disorder (ASA III or IV).
- •Gastrointestinal disorders.
- •If the initial diagnosis revealed pain in more than one tooth.
- •Hemostatic disorders or anti-coagulant therapy during the last month.
- •Consumption of opioid or non-opioid analgesics or NSAIDs during the last 12 hours before treatment.
- •Teeth that have:
- •i. Periodontal involvement (with pocket depth greater than 5mm, associated with swelling or fistulous tract, or greater than grade I mobility).
- •ii. No possible restorability. iii.Signs of pulpal necrosis; associated sinus tract or swelling.
研究组 & 干预措施
Diclofenac Potassium
0.4 ml diclofena potassium injection 75mg/3ml drug used as Supplemental intraligamentary injection
干预措施: Diclofenac Potassium (Drug)
Articaine Anaesthetic solution
Articaine 4% with (1:100,000 Epinephrine) local anesthetic solution will be used as intraligamentary injection,
干预措施: Diclofenac Potassium (Drug)
结局指标
主要结局
Efficacy of local anesthesia
时间窗: intraoperative ( access cavity preparation & instrumentation ) during root canal treatment
using Heft parker Visual Analogue scale Binary where success is defined as no pain or faint/weak /mild pain\<55 mm). if \>55 defined as failure
次要结局
- Post-operative pain(6, 12, 24 and 48 hours post-operatively)
- Number of needed analgesic tablets in case of intolerable pain(Up to 2 days post operatively)
- Intensity of intraoperative pain(intraoperative ( access cavity preparation & instrumentation ) during root canal treatment)
研究者
Mai Abdou Ibraheem
Resident at faculty of dentistry
Cairo University