Evaluation of the Antibacterial Potential of Nano Calcium Hydroxide as an Intracanal Medication: A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- bacterial count
研究概览
简要总结
The aim of the study is to evaluate the anti-bacterial potential of Nano Calcium Hydroxide as an intracanal medication in primary endodontic treatment of permanent molars.
详细描述
This study is conducted to evaluate the bacterial reduction capability of hydrogel loaded with Nano Calcium Hydroxide and paste form of nano and conventional calcium hydroxide as an intracanal medication. The hydrogel will be synthesized in a new rapid in situ form that can turn from liquid into gel when reaching body temperature. The efficacy of bacterial reduction will be compared with Nano Calcium Hydroxide and conventional Calcium Hydroxide in paste form. The evaluation is to be done by quantitative microbiological assessment of samples which are gained from the root canal before and after intracanal medication 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
- 21 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy males and females.
- •age range between 21-
- •patients with no physical disability or psychological problems.
- •patients presenting with single permanent molar with signs and/or symptoms of apical periodontitis, and having Periapican index ≥ 2.
排除标准
- •pregnant women.
- •patients with immune-compromised disease.
- •patients with complicated systemic diseases.
- •patients who took antibiotics within a period of 1 month.
- •patients with known sensitivity to the medicaments or pharmaceuticals used in this study.
- •Non-restorable teeth including root fractures, and/or advanced periodontal involvement.
研究组 & 干预措施
Nano calcium hydroxide in hydrogel form
nano calcium hydroxide in hydrogel form is placed in the dry root canals after complete cleaning and shaping procedure.The intracanal medication will be distributed to fill the canals up to the orifice level.
干预措施: nano calcium hydroxide (Drug)
Nano calcium hydroxide in paste form
nano calcium hydroxide in paste form is placed in the dry root canals after complete cleaning and shaping procedure. The intracanal medication will be distributed to fill the canals up to the orifice level.
干预措施: nano calcium hydroxide (Drug)
Conventional calcium hydroxide in paste form
conventional calcium hydroxide in paste form is placed in the dry root canals after complete cleaning and shaping procedure.The intracanal medication will be distributed to fill the canals up to the orifice level.
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 intercanal medication placement appointment
variation in bacterial count between 'nano calcium in hydrogel form' group compared with the other groups. The evaluation will be done by quantitative microbiological assessment test. Three microbiological samples will be collected from each patient. Sterile paper points will be used for collecting intracanal content and it will be sealed in Eppendorf tube until the samples reach laboratory center. Tubes will be labelled as following: S1 - S2 - S3 according to the stage of obtaining the sample. S1: will be obtained after access cavity and patency of canals S2: will be obtained by paper point that match the size of master apical file, after complete cleaning and shaping. S3: will be obtained on the seventh day from the intracanal placement appointment. paper points will be used after complete removal of the intracanal medication from the root canals.
次要结局
- periapical healing(participants will be recalled after 6 months from the obturation for radiographic examination)
- incidence and intensity of pain(Pain intensity will be assessed each day for three days following initial treatment)
- incidence of flare up(incidence of flare up will be recorded each day after the intracanal medication placment visit until the next visit (after seven days))
研究者
Nada
official investigator
British University In Egypt