Effect of Diclofenac Sodium Versus Calcium Hydroxide as Intracanal Medication on the Intensity of Postoperative Pain, Bacterial Load Reduction and MMP-9 Levels in Patients With Necrotic Pulp: A Randomized Clinical Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- change in Intensity of postoperative pain
研究概览
简要总结
the aim of this study is to compare the effect of using Diclofenac Sodium Versus Calcium Hydroxide as Intracanal medication on intensity of postoperative pain, bacterial load reduction after root canal preparation and periapical matrix metalloproteinase 9 level (MMP-9) post-instrumentation and pre-obturation in teeth with necrotic pulp
详细描述
To compare the effect of diclofenac sodium versus calcium hydroxide as intra canal medication on:
- Primary Outcome Intensity of postoperative pain will be measured using numerical rating scale (NRS) at 6, 12, 24 and 48- hours post-instrumentation and at 6, 12, 24 and 48 hours post-obturation.
Secondary Outcome 1 Bacterial load reduction will be determined by bacterial counting using agar culture technique after root canal preparation (CFU/ml).
Secondary Outcome 2 Periapical MMP-9 level will be determined post-instrumentation and pre-obturation by ELISA.
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, Investigator)
盲法说明
- In this proposed study, both the participant and assessor will be blinded. This is achieved where the outcome assessor will not be informed of the group in which the participant is enrolled for subjective outcomes. The participants will be blinded to the study hypothesis as to which intervention is expected to be better.
- The patients who already do not know their treatment group will assess the level of their post-operative pain.
- The laboratory technician at the microbiological department will not know the treatment group of the patients.
- The treatment groups will remain anonymous at the end of the study during assessment by the statistician.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria:
- •Patients who are free from any physical or mental handicapping condition with no underlying systemic disease.
- •Age between 18-50 years.
- •Males & Females.
- •Mandibular single rooted permanent premolar teeth:
- •Diagnosed clinically with pulp necrosis.
- •Absence of spontaneous pain.
- •Positive pain on percussion denoting apical periodontitis.
- •Slight widening in the periodontal membrane space or with periapical radiolucency not exceeding 2*2 mm radiographically.
- •Patients' acceptance to participate in the trial.
- •Patients who can understand pain scale and can sign the informed consent
排除标准
- •Medically compromised patients
- •Pregnant women.
- •If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively.
- •Patients reporting bruxism or clenching.
- •Teeth that show association with acute periapical abscess and swelling.
- •Greater than grade I mobility or pocket depth greater than 5mm.
- •Non-restorable teeth
- •Teeth with vital pulp.
- •Immature teeth.
- •Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.
研究组 & 干预措施
calcium hydroxide
calcium hydroxide will be placed as intracanal medication between visits.
干预措施: Diclofenac Sodium (Drug)
diclofenac sodium
diclofenac sodium will be placed as intracanal medication between visits
干预措施: Diclofenac Sodium (Drug)
结局指标
主要结局
change in Intensity of postoperative pain
时间窗: 6,12.24.48 hours
measured using numerical rating scale (NRS) at 6, 12, 24 and 48- hours post-instrumentation and at 6, 12, 24 and 48 hours post-obturation.
次要结局
- Bacterial load reduction(7 days)
研究者
mohammed awadd
assistant lecturer
Cairo University