Evaluation of Postoperative Pain After Using 3MIX-TATIN Versus Calcium Hydroxide Iodoform Paste In Necrotic Primary Molars Treated by Lesion Sterilization and Tissue Repair Therapy: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- pain
研究概览
简要总结
The aim of the current study is to compare a newly introduced material which is a combination of triple mix antibiotics paste and anti-hyperlipidemia drug simvastatin, the new material is named 3MIX-TATIN & will be compared to triple antibiotic paste for management of necrotic primary molars by using lesion sterilization and tissue repair LSTR technique.
详细描述
3Mix-tatin will prepared by mixing three commercially available antibiotics with simvastatin. After removing the coating materials, 3 types of antibiotics are pulverized by porcelain mortars and pestles to achieve fine powders. A total of 100 mg ciprofloxacin, 100 mg metronidazole, and 100 mg cefixime will be mixed in a ratio of 1: 1: 1. Two milligrams of simvastatin will be added to the drugs blend to form 3-Mix-tatin. Preparation of 3Mixtatin will be trained and supervised by an expert pharmacist. 3Mixtatin will be stored in a tightly capped porcelain container, adding a small amount of silica gel in a bag inside the container to maintain low humidity. This powder will be mixed with normal saline to form a creamy paste of 3Mixtatin at the time of application.
Local anesthesia using mepivicaine hydrochloride 3% (septodont, saint-maurdesFosses, France) will be administered.
Rubber dam isolation.
Access cavity will be prepared with a fissure bur in a high-speed handpiece, necrotic pulp tissue will be removed using a sterile sharp spoon excavator.
The canal orifices will be enlarged with a round bur (one mm diameter and two mm depth) to create medication receptacles.
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, Care Provider)
入排标准
- 年龄范围
- 5 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children age range from 5-8 years.
- •Children free from any systemic diseases or medical problems.
- •Primary molar with necrotic pulp, with pain, gingival abscess, fistula openings, or clinical mobility not exceeding grade two.
- •Radiographic evidence of non-perforating internal resorption, external resorption not exceeding 1\3 of the root, furcation or periapical radiolucency.
- •Exclusion criteria:
- •Non-restorable molars or beyond repair, for example: decay reaches to bifurcation, a hard gingival margin cannot be established or infection cannot be eradicated by other mean (Balaji, 2007).
- •Patient with known allergy to any type of antibiotics or anti-hyperlipidemia drugs.
- •Patient with facial cellulitis or lymphadenopathy
- •Lack of patient/parent compliance and cooperation.
- •Refusal of participation or failure to obtain an informed consent.
排除标准
- 未提供
研究组 & 干预措施
calcium hydroxide iodoform paste
intervention administered to control group is a combination of drugs as follow: ciprofloxacin 500mg, cefixime 500 mg, metronidazole 500 mg, simvastain 40mg. all are mixed, placed in pulp chamber only one time and tooth is restored
干预措施: 3-mixtatin (Drug)
3-mixtatin
intervention administered to experimental group is a ready made mixture of calcium hydroxide and iodoform, placed in pulp chamber only one time and tooth is restored
干预措施: Calcium Hydroxide, Iodoform, paste (Drug)
结局指标
主要结局
pain
时间窗: at 3rd months
measurment of post-operative pain by a questionnaire either present or absent
次要结局
- mobility(at 9th month)
- swelling(at 9th month)
研究者
Mahmoud M Saadoon
resident dr, department of pedodontics, cairo University
Cairo University