Comparative Evaluation of Intraligamentary Injection of Dexamethasone, Diclofenac Sodium, and Chymotrypsin for Enhancing the Success of 4% Articaine Buccal Infiltration in Mandibular Molars With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Anesthetic success defined as no response to thermal test, electric pulp test and lip numbness and no pain (VAS ≤ 0 or no subjective pain/stimulation response) during endodontic access and initial instrumentation without need for additional anesthesia
研究概览
简要总结
The goal of this clinical trial is to compare anesthetic success rates of intraligamentary dexamethasone, diclofenac sodium, and chymotrypsin administered prior to buccal 4% articaine infiltration in mandibular molars with symptomatic irreversible pulpitis. Do these drugs lower the number of times participants need to be administrated with more local anesthesia? Researchers compared intraligamentary dexamethasone, diclofenac sodium, and chymotrypsin to a placebo (a look-alike substance that contains no drug) to see if interventional drugs work to achieve successful anesthesia.
- Participants were intraligamentary injected by drugs or a placebo once prior to buccal infiltration anesthesia
- Participants reported pain intensity using VAS at baseline (pre-injection), during access, and at 6, 24, 48 hours post-operative (patient diary / phone follow-up).
- Participants reported the onset time to subjective numbness (time from buccal infiltration to lip/tongue numbness).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systemically healthy male patients (ASA I or II)
- •Aged 18 to 50 years
- •Presenting with symptomatic irreversible pulpitis in a restorable mandibular molar
- •Preoperative moderate to severe pain (VAS ≥45 mm)
- •Normal periapical tissue (no radiolucency, pocket depth ≤5 mm, mobility ≤ Grade I)
排除标准
- •Medically compromised patients (ASA III or higher)
- •History of allergy or intolerance to chymotrypsin, dexamethasone, diclofenac sodium, articaine.
- •Vertical root fracture
- •External or internal root resorption
- •Periodontal pocket depth >5 mm
- •Tooth mobility Grade II or III
- •Presence of periapical lesion (radiolucency)
研究组 & 干预措施
placebo
intraligamentary saline administered prior to buccal 4% articaine infiltration in mandibular molars with symptomatic irreversible pulpitis
干预措施: Dexamathsone 4mg/ml associated with experimental arm (Drug)
placebo
intraligamentary saline administered prior to buccal 4% articaine infiltration in mandibular molars with symptomatic irreversible pulpitis
干预措施: Diclofenac Sodium (DCS) (Drug)
articaine
干预措施: Dexamathsone 4mg/ml associated with experimental arm (Drug)
articaine
干预措施: Diclofenac Sodium (DCS) (Drug)
articaine
干预措施: chymotrypsin (Drug)
placebo
intraligamentary saline administered prior to buccal 4% articaine infiltration in mandibular molars with symptomatic irreversible pulpitis
干预措施: chymotrypsin (Drug)
结局指标
主要结局
Anesthetic success defined as no response to thermal test, electric pulp test and lip numbness and no pain (VAS ≤ 0 or no subjective pain/stimulation response) during endodontic access and initial instrumentation without need for additional anesthesia
时间窗: from anesthsesia administartion till 48 hours postoperative
次要结局
未报告次要终点
研究者
Mohamed Nageh
Associate professor
Fayoum University