Effect of Boswellia Sacra Versus Calcium Hydroxide as an Intracanal Medicament on Postoperative Pain Intensity and Bacterial Load Reduction in Necrotic Mandibular Premolars: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Postoperative pain measured using numerical rating scale
研究概览
简要总结
This research will study the effect of Boswellia Sacra versus calcium hydroxide as an intracanal medicament on postoperative pain intensity measured using numerical rating scale (NRS) and bacterial load reduction reduction determined by bacterial counting using agar culture technique after root canal preparation (CFU/ml) in mandibular premolars with necrotic pulp.
详细描述
Primary outcome Postoperative pain measured using numerical rating scale (NRS)
- After placement of intracanal medicament at 6, 12, 24 and 48 hours.
- After root canal obturation at 6, 12, 24 and 48 hours.
Secondary outcomes Bacterial load reduction determined by bacterial counting using agar culture technique after root canal preparation (CFU/ml) .
- Sample 1 (S1): after access preparation and pre-instrumentation.
- Sample 2 (S2): post-instrumentation.
- Sample 3 (S3): post-intracanal medicament removal at 3 or 7 days according to the group.
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)
盲法说明
Outcome assessors (patients, microbiologist and statistician) will not know Which group the participants will be related to?
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 25-45 years old.
- •Males or females.
- •Healthy patients whom are categorized as I or II according to The American Society of Anesthesiologists. (ASA I or II)
- •Patients' accepting to participate in the trial.
- •Patients who can understand pain scale and can sign the informed consent.
- •Mandibular Single rooted premolars, having single root canal:
- •Diagnosed clinically with pulp necrosis.
- •Absence of spontaneous pulpal pain.
- •Positive pain on percussion denoting apical periodontitis.
- •Periapical radiolucency not exceeding 2*2 mm radiographically.
- •Normal occlusal contact with opposing teeth.
排除标准
- •Medically compromised patients having significant systemic disorders (ASA III or IV).
- •If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively as it might alter their pain perception.
- •Pregnant women: to avoid radiation exposure, anesthesia, medication and hormonal Fluctuation that might increase pain prevalence.
- •Patients reporting bruxism, clenching, TMJ problems or traumatic occlusion: to avoid further pressure on inflamed tooth which induce subsequent irritation and inflammation.
- •Patients with two or more adjacent teeth requiring endodontic treatment.
- •Teeth that requires further procedural steps or multidisciplinary approach, which is out of this experiment's scope:
- •i. Association with swelling or fistulous tract. ii. Acute periapical abscess. iii. Mobility Grade II or III. iv. Pocket depth more than 5mm. v. Previous root canal treatment. vi. Non -restorable vii. Immature roots viii. Radiographic evidence of external or internal root resorption, vertical root fracture, perforation, calcification.
- •Inability to perceive the given instructions.
结局指标
主要结局
Postoperative pain measured using numerical rating scale
时间窗: 48 hours.
postoperative pain will be recorded after placement of intracanal medicament and after root canal obturation using numerical rating scale ,An 11-point scale from 0-10 representing pain intensity ,"10" being the most intense pain conceivable.
次要结局
- Incidence of analgesic intake after root canal treatment(Up to 48 hours post- operatively)
- Incidence of inter-appointment swelling(Up to 48 hours post- operatively)
- Bacterial load reduction(T0=Baseline immediate after access preparation . T1=Post-instrumentation. T3=post-intracanal medicament removal at 3 or 7 days according to the group.)
研究者
Aya Helmy Abd-Elghafar Abo Kashwa
Principal investigator
Cairo University