Effect of NanoChitosan Impregnated Calcium Hydroxide Paste as an Intracanal Medication on the Intensity of Postoperative Pain and Bacterial Load Reduction in Necrotic Teeth: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 45
- 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 NanoChitosan impregnated Calcium Hydroxide versus Calcium Hydroxide as an intracanal medication on postoperative pain intensity measured using numerical rating scale (NRS) and bacterial load reduction determined by bacterial counting using agar culture technique after root canal preparation (CFU/ml) in necrotic teeth.
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 outcome: 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 7 days.
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 and statistician) will not know which group the participants are 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 who 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 the pain scale and can sign the informed consent.
- •Mandibular Single rooted premolars, having single root canal: Diagnosed clinically with pulp necrosis.
- •Positive pain on percussion denoting apical periodontitis.(20)
- •Slight widening in the periodontal membrane space
- •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.
- •Pregnant women
- •Patients reporting bruxism, clenching, TMJ problems or traumatic occlusion
- •Patients with two or more adjacent teeth requiring endodontic treatment.
- •Teeth that require further procedural steps or multidisciplinary approach.
- •Association with swelling or fistulous tract.
- •Acute periapical abscess.
- •Mobility Grade II or III.
- •Pocket depth more than 5mm.
- •Previous root canal treatment.
- •Non-restorable.
- •Immature root.
- •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 inter- appointment flare up(Up to 48 hours post- operatively)
- Bacterial load reduction(T0=Baseline immediate after access preparation . T1=Post-instrumentation. T2=post-intracanal medicament removal at 7 days.)
- Number of analgesic tablets taken by the patient after endodontic treatment(Up to 48 hours post- operatively)
研究者
Yasmine Osama ElGhannam
Principal Investigator
Cairo University