Comparison of the Effects of Different Natural and Synthetic Intracanal Medicaments on the Healing of Periapical Lesion in Retreatment Cases (A Randomized Clinical Trial)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- healing of periapical lesion
研究概览
简要总结
The goal of this clinical trial is to compare the effects of different intracanal medication between endodontic retreatment visits in previously failed root canal treatment patients (single root canal anteriors or premolars teeth). The main question it aims to answer are:
- Is natural and synthetic intracanal Medicament effective in reducing or complete healing of Periapical lesions or not? the researchers will compare the effect of different intracanal dressing including:
- nanocurcumin gel
- curcumin gel
- ciprofloxacin +ibuprofen gel
- calcium hydroxide Paste as control group in between the endodontic retreatment visits to see if these medicaments work well on periapical lesion healing this outcome measured by Cone beam CT at base and after 1 year follow up period
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
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medically free Patients
- •both sex includes male and females
- •Patients age between 20-60
- •Patients agreement positively to share in the study
- •patient able to sign informed consent
- •on clinical and radiographic examinations, the included teeth maxillary and mandibular single root canal anteriors or premolars suffering from failed endodontic treatment with periapical lesion
排除标准
- •badly broken down teeth indicated for extraction or with difficult isolation
- •teeth with former procedural errors as ledge, perforation or instrument separation
- •Medically compromised patients
- •patients with history of receiving antibiotics within a month before starting study
- •periodontally affected teeth by pocket depth & > 4mm
研究组 & 干预措施
Nanocurcumin gel .
Preparation Method: Olive oil (5%), surfactant (Tween 80 (8%)) and co-surfactant (PEG 400 (2%)) were used as excipients and their selection was based on the solubility of curcumin. A high-energy ultrasonication techniquewas used to prepare the Cur-NE. Curcumin (0.3%) was dissolved in oil /surfactant/ co-surfactant mixture and stirred till obtaining clear solution. The mixture was microtitrated with distilled water (85 %) to achieve a coarse emulsion. A 20 kHz ultrasonic processor was used for the production of the desired nano-emulsion.
Gel Preparation:
0.4gm of Carboxymethyl cellulose (Loba CHIME, india) was sprinkled gently and gradually over the solution of Cur NE 0.3% under mild temperature with vigorous stirring to get homogenous gel
干预措施: nanocurcumin gel (Drug)
Curcumin gel
curcumin 250 mg powder + carboxymethyl cellulose 300mg+distilled water to 10ml
干预措施: Curcumin Gel (Drug)
Ciprofloxacin 500 mg +Ibuprofen 400 mg
Ciprofloxacin 500 mg +ibuprofen 400mg powder +carboxymethyl cellulose 300 mg +distilled water to 10 ml
干预措施: Ciprofloxacin 500 mg +ibuprofen 400mg (Drug)
calcium hydroxide
Metapaste
干预措施: Metapaste [calcium hydroxide paste (control group)] (Drug)
结局指标
主要结局
healing of periapical lesion
时间窗: 1 year
measured radiographically the periapical lesion volmetric changes by CBCT between preoperative and after1 year follow up
次要结局
- antibacterial effect (CFU)(at first visit : S1 :baseline sample, S2 : sample immediately after chemomechanical procedure , at second visit S3: sample after 7 days of placement medication)
- Interappointment Pain(6,12, 24, 48, 72 hours after 1st visit)
研究者
Rawda Baghdady
Principle investigator
Ain Shams University