Nano-based Medicaments Versus Double Antibiotic Paste in Managing Non-vital Primary Molars: A Randomized Clinical Trial and In-Vitro Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Clinical success
研究概览
简要总结
Management of non-vital primary molars is challenging due to the natural anatomy of primary teeth, patients' young age, and their behavior toward dental treatment. A simple and effective technique such as Lesion Sterilization and Tissue Repair offers a solution to cases with poor prognosis; however, the medicaments used in this technique have some limitations. This study will evaluate three different medicaments regarding the clinical success, radiographic success, and antibacterial activity.
详细描述
This randomized controlled trial will include 108 non-vital mandibular primary molars in children aged 4-8. Patients will be randomly allocated into three groups according to the studied medicaments as one positive control group and two experimental groups. The groups are as follows:
Group I (conventional double antibiotic paste) positive control group Group II (double antibiotic paste-loaded chitosan-coated silver nanoparticles) experimental group Group III (chitosan-coated silver nanoparticles) experimental group
The antibacterial activity of studied medicaments will be tested against Enterococcus Faecalis bacteria in planktonic and biofilm forms. Teeth will be evaluated clinically and radiographically to obtain baseline data. After local anesthesia administration and isolation of teeth, an access cavity will be performed, then the medicament will be placed over the floor of the pulp chamber according to the corresponding group. Afterwards, teeth will be filled with resin-modified zinc oxide and eugenol followed by stainless steel crowns. Blinded clinical evaluation will be done at baseline, 1, 6, and 12 months and blinded radiographic evaluation will be done at baseline, 6, and 12 months.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 双盲 (受试者、结局评估者)
盲法说明
The current study will be a triple-blind study. The participants will be blind to the study groups they will be assigned to. The evaluators will also be blind to the study groups during clinical and radiographic examination. The operator will not be blind to the study groups because of the difference between the used medicaments. The statistician will be unaware of the study group's allocation during statistical analysis of the data collected.
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- Healthy cooperative children of both sexes in the age range of 4-8 years old.
- Children with consenting parents who accept to participate in the study and sign the consent forms.
- Children with mandibular primary molars with clinical and radiographic signs of pulpal necrosis.
排除标准
- Children with hypersensitivity to any of the used medicaments.
- Non-restorable teeth without sufficient coronal structure for placement of rubber dam isolation and restoration with stainless steel crowns
- Non-restorable teeth with perforated pulpal floor
研究组 & 干预措施
Conventional double antibiotic paste
After local anesthesia administration and rubber dam isolation, access cavity will be performed and the studied medicament will be placed onto the floor of the pulp chamber. Teeth will be finally restored with stainless steel crowns in the same visit.
干预措施: Conventional double antibiotic paste of Metronidazole 500 mg plus Ciprofloxacin 500 mg mixed with propylene glycol (Drug)
double antibiotic paste-loaded chitosan-coated silver nanoparticles
After local anesthesia administration and rubber dam isolation, access cavity will be performed and the studied medicament will be placed onto the floor of the pulp chamber. Teeth will be finally restored with stainless steel crowns in the same visit.
干预措施: Double antibiotic paste of Metronidazole and Ciprofloxacin loaded chitosan-coated silver nanoparticles (Drug)
chitosan-coated silver nanoparticles
After local anesthesia administration and rubber dam isolation, access cavity will be performed and the studied medicament will be placed onto the floor of the pulp chamber. Teeth will be finally restored with stainless steel crowns in the same visit.
干预措施: chitosan-coated silver nanoparticles (Drug)
结局指标
主要结局
Clinical success
时间窗: 1,6, and 12 months follow up
1. Absence/decrease of pain related to the treated teeth including patient reported pain or sensitivity to palpation/percussion 2. Absence/decrease of gingival swelling related to the treated teeth 3. Absence/decrease of pathological mobility related to the treated teeth
Radiographic success
时间窗: 6 and 12 months follow up
1. Absence/decrease/stasis of furcation radiolucency related to the treated teeth 2. Absence/stasis of pathological root resorption of the treated teeth
次要结局
- Antibacterial activity of studied medicaments against Enterococcus Faecalis bacteria(2 weeks)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT06926322
- 其他研究编号
- PED-25-D1
日期
- 首次提交
- (去年)
- 首次发布
- (去年)
- 主要完成日期
- (10个月后)
- 研究完成日期
- (3年后)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- UNDECIDED
- 是否有结果
- 否