Clinical and Radiographic Evaluation of Lesion Sterilization and Tissue Repair in Non-vital Primary Molars Using Double Antibiotic Paste With Two Different Vehicles (Randomized Clinical Trial and In Vitro Study)
试验速览
- 阶段
- 3 期
- 入组人数
- 36
- 主要终点
- Clinical outcomes through clinical examination
研究概览
简要总结
LSTR will be done for primary teeth with significant root resorption needing non-vital pulp therapy to save such teeth for up to 12 months. The first part will be in vitro study to compare the antimicrobial effect of double antibiotic paste mixed with chitosan nanoparticle vs double antibiotic paste mixed with propylene glycol. The second part will be randomized clinical trial comparing the clinical and radiographic success of LSTR in study group where double antibiotic mix is mixed with chitosan nanoparticles and control group where double antibiotic paste is mixed with propylene glycol .
详细描述
Clinical and Radiographic Evaluation of Lesion Sterilization and Tissue Repair in Non-vital Primary Molars Using Double Antibiotic Paste with Two Different Vehicles (Randomized Clinical Trial and In Vitro Study)
Introduction:
Healthy primary teeth are important for speech, mastication and to maintain the space for their permanent successors developing in the jaw underneath. Teeth with infected root canals, particularly those in which the infection has reached the peri-radicular tissues, are a common problem in the primary dentition. A relatively new biologic approach, lesion sterilization and tissue repair therapy (LSTR) was introduced. It was modified from 3 mix 1:1:1 metronidazole, ciprofloxacin and minocycline to double mix where 1:1 metronidazole and ciprofloxacin are mixed with propylene glycol. It is indicated for primary teeth with significant root resorption (external resorption greater than 1 mm and/ or internal resorption) needing non-vital pulp therapy. It is also indicated when the clinician decides not to extract the tooth with significant preoperative root resorption, LSTR should be the choice over pulpectomy to save such teeth for up to 12 months. Chitosan it is a natural nontoxic, biocompatible, biodegradable polysaccharide with broad antibacterial spectrum (covering gram-negative and gram-positive bacteria as well as fungi), and it has antioxidant and antitumor properties, also it has the ability to form film and gel. Chitosan and chitosan nanoparticle can be used as a vehicle for incorporating natural or chemical antimicrobial agents, however, chitosan nanoparticles exhibit a higher antimicrobial activity than chitosan. Also, chitosan nanoparticles have better absorption and penetration into dentinal tubules
Aim of Study:
- To evaluate the clinical and radiographic outcomes of using double antibiotic paste mixed with chitosan nanoparticles gel vs. double antibiotic paste mixed with propylene glycol in lesion sterilization and tissue repair in non-vital primary molars.
- Both materials will be compared in terms of ease of handling, time to perform procedure and convenience of application.
- Comparing the antibacterial effect of double antibiotic paste mixed with chitosan nanoparticles gel vs. that mixed with propylene glycol in vitro.
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
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1-Non-vital primary molars
- •With root resorption more than 1 mm that needs to be retained a tooth for up to 12 months that otherwise would be extracted
- •Without mobility up to grade I mobility.
排除标准
- •Non-vital primary molars
- •With perforation into the bifurcation.
- •Badly broken down.
- •With no root resorption.
- •With excessive bone loss in furcation area involving underlying tooth germ.
- •Nearing exfoliation.
- •Participants that
- •Have previous history of allergy to the antibiotics used in the study.
- •Their caregivers do not oblige to signing the informed consent.
研究组 & 干预措施
Group 1
study group
干预措施: Double antibiotic paste mixed with chitosan nanoparticles (Drug)
Group 2
control group
干预措施: Double antibiotic paste mixed with propylene glycol (Drug)
结局指标
主要结局
Clinical outcomes through clinical examination
时间窗: Follow up will be for one year with recall visits at 1, 3, 6 and 12 months
No pain. No abnormal mobility. No swelling
Radiographic outcomes by comparing pre and post treatment radiographic pathologic radiolucent area/s size/s
时间窗: Follow up will be for one year with recall visits at 1, 3, 6 and 12 months
Decrease in size / absence of interradicular radiolucency. Decrease in size /absence of internal resorption.
次要结局
未报告次要终点
研究者
Dina Abdel Halim
assisting teacher
Ain Shams University