Evaluation of Post-Operative Pain After Regenerative Endodontic Using Photo-Activated Oral Disinfection Versus Triple-Antibiotic Paste for Management of Necrotic Young Permanent Anterior Teeth
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- absence of postoperative pain
研究概览
简要总结
This study aims to compare regenerative endodontics for necrotic young permanent anterior teeth using oral photo-activated disinfection versus triple antibiotic paste in terms of:
- Clinical success in terms of absence of any complication such as spontaneous pain, sinus or swelling.
- Radiographic success in terms of healing of periapical radiolucency or increase root thickness, length or apical closure.
详细描述
Disinfection of the root canal system is thought to be critical to the success of Regenerative Endodontic Procedures (REPs) as infection prevents regeneration, repair and stem cell activity . A suitable material for using as intra-canal medicament seems to be antibiotic. Triple antibiotic paste (TAP) containing metronidazole, ciprofloxacin and minocycline has been reported to be a successful regimen in controlling the root canal pathogen and in managing necrotic young permanent tooth .
Recently, new disinfection methods have been developed to overcome the limitations of conventional disinfecting protocols that they may neither reduce the number of bacteria to a satisfactory level nor minimize the toxicity to periapical stem/progenitors . Other concerns regarding the use of TAP are tooth discoloration after treatment and bacterial resistance. Photo-activated oral disinfection is a novel disinfection method which present a great solution for the problem associated with triple antibiotic paste
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
- 8 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children with no physical, mental or systemic conditions.
- •Developmental age of the child is the most important factor so periapical x- ray will be taken first to assure apex immaturity.
- •No sex predilection.
- •Restorable necrotic young permanent anterior teeth
排除标准
- •Root fracture.
- •Internal or external root resorption.
- •Parents or guardians refuse to participate in the study.
研究组 & 干预措施
Photo Activated Disinfection
Photoactivated disinfection (PAD) is based on the interaction of a photosensitive antibacterial agent and a light source. It uses a nontoxic dye [named photosensitizer PS] and low-intensity visible light. In oxygen presentation, these combine to produce some cytotoxic species. The PS molecules attach to bacteria membrane
干预措施: Photo Activated Disinfection (Device)
Antibiotic paste
Hoshino et al. recommended a ratio of 1:1:1 of metronidazole (500 mg), minocycline (100 mg) and ciprofloxacin (200 mg) for the 3Mix formulation
干预措施: antibiotic paste (Drug)
结局指标
主要结局
absence of postoperative pain
时间窗: at 12 months follow up
binary question by asking patients (yes or no)
次要结局
- healing of sinus(immediate post operative, 3 months, 6 months, 9 months, 12 months)
- change in root length(baseline, 6 months, 12 months)
- change in apical diameter(baseline, 6 months, 12 months)
- healing of periapical radiolucency(baseline, 6 months, 12 months)
- change in dentin root thickness(baseline, 6 months, 12 months)
- healing of swelling(immediate post operative, 3 months, 6 months, 9 months, 12 months)
研究者
ElShaimaa Abdelhafiz Abdelrahim
assistant lecturer in paediatric dentistry department at Fayoum university
Cairo University