The Antimicrobial Potential of Diclofenac Sodium as an Intracanal Medicament During Root Canal Treatment: A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Bacterial count
研究概览
简要总结
The goal of this randomized clinical trial is to evaluate the capability of the material to exert bacterial reduction of diclofenac sodium versus of that calcium hydroxide paste when these materials are used as intracanal medications in permanent molar teeth with chronic apical periodontitis.
The main question[s] it aims to answer are:
• Will the diclofenac sodium (NSAIDs) possess antimicrobial efficacy to be used effectively as an intracanal medicament similar to that of calcium hydroxide in primary endodontic treatment? Participants will be allocated randomly into three equal groups by using computer generated randomization, according to the type of intracanal medication.
详细描述
The aim of the present study is to evaluate the capability of the material to exert bacterial reduction of diclofenac sodium versus of that calcium hydroxide paste when these materials are used as intracanal medications in permanent molar teeth with chronic apical periodontitis. The evaluation is to be done using quantitative microbiological assessment from samples extracted from root canals before and after intracanal medicament placement in roots of permanent molars, having PAI score ≥ 2.
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)
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
- •Patients with teeth diagnosed with apical periodontitis
- •Periapical Index (PAI) ≥ 2
- •The teeth are restorable
排除标准
- •Teeth with immature roots
- •Non restorable teeth
- •Medically compromised patients with systemic complication that would alter the treatment.
- •Teeth with internal/external root resorption
- •Patient with an allergy to diclofenac sodium
研究组 & 干预措施
High concentration of diclofenac sodium
High concentration of diclofenac sodium mixed with saline
干预措施: Diclofenac Sodium (Drug)
Low concentration of diclofenac sodium
Low concentration of diclofenac sodium mixed with saline
干预措施: Diclofenac Sodium (Drug)
Calcium hydroxide
Calcium hydroxide paste form
干预措施: Calcium hydroxide (Drug)
结局指标
主要结局
Bacterial count
时间窗: On the seventh day from of intracanal medication placement appointment
Variation in bacterial count in high concentration of Diclofenac Sodium group compared by group of low concentration of Diclofenac Sodium group and calcium hydroxide group.
次要结局
- incidence and intensity of pain(Pain intensity will be assessed at 24 hours, 48 hours and 72 hours following initial treatment using a visual analogue scale)
- Periapical healing(participants will be recalled after 6 months from the obturation for radiographic examination.)
- Incidence of flare-ups(Presence of flare-ups will be recorded each day after the intracanal medication placement visit till the next visit (after seven days).)
研究者
Summer Elsayed
Principle Investigator
British University In Egypt