NCT05289843Unknown不适用
Effect of Rosmarinus Officinalis Versus 2.5%Sodium Hypochlorite as Root Canal Irrigants on the Intensity of Post-operative Pain and Bacterial Reduction in Asymptomatic Necrotic Mandibular Premolars
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 26
- 主要终点
- Postoperative pain after root canal treatment.
研究概览
简要总结
To measure the Effect of Rosmarinus Officinalis versus 2.5%Sodium Hypochlorite as Root canal Irrigants on the Intensity of post-operative pain and Bacterial Reduction in asymptomatic necrotic Mandibular premolars.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Triple (Participant , Investigator, Outcomes assessor
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systematically healthy patient (ASA I and II).
- •Age between 20 and 45 years with no sex predilection
- •Mandibular permanent premolar teeth:
- •Diagnosed clinically with pulp necrosis.
- •Absence of spontaneous pain.
- •Radiographic evidence of root and root canal.
- •Slight widening in the periodontal membrane space or with periapical radiolucency.
- •No response to cold pulp tester (ethyl chloride spray)
- •Patients who can understand and interpret Numerical rating scale (NRS).
- •Patients' acceptance to participate in the trial
排除标准
- •1- Medically compromised patients having significant systemic disorders. (ASA III or IV).
- •2- History of intolerance to NSAIDS. 3- If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively as it might alter their pain perception.
- •4- Pregnant women: Avoid radiation exposure, anesthesia, and medication. 5- Teeth with: i. Vital teeth. ii. Double canal mandibular premolar teeth iii. Association with swelling or fistulous tract. iv. Acute peri-apical abscess and swelling: Need special treatment steps which could involve additional visits with incision and drainage. Also, it could influence initiation and progression of postoperative pain.
- •v. Mobility Grade II or III. vi. Pocket depth more than 5mm. vii. Previous root canal therapy. viii. Non-restorable teeth: Hopeless tooth
- •Immature teeth.
- •Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.
结局指标
主要结局
Postoperative pain after root canal treatment.
时间窗: Up to 48 hours postoperative.
The patient is asked to grade his degree of pain on the Numerical Rating Scale (NRS) chart which is an 11 points scale consisting of numbers from 0 to 10, where zero reading represents no pain , 1-3 readings represent mild pain, 4-6 readings represent moderate pain. 7-10 readings represent severe pain .
次要结局
- Intracanal bacterial load change.(First as a base line and after 15 minutes ( End of the chemo-mechanical preparation).)
研究者
Ayah Tarek El Sayed Abudlaah
Principal investigator and Master degree student at faculty of dentistry , Cairo university
Cairo University
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