A Prospective Clinical Study of Regenerative Endodontic Treatment of Traumatised Non-vital Immature Teeth Using Bi-antibiotic Paste
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 主要终点
- Change in root length
研究概览
简要总结
Aim: The aim of this prospective study was to evaluate the treatment outcomes of regenerative endodontic technique (RET) for the management of traumatised non-vital immature teeth in children. Methodology: This study aims to recruit 25-30 healthy children with traumatised non-vital immature upper incisors to be treated with bi-antibiotic regenerative endodontic technique. Patients will be reviewed clinically at 3m,6m,9m,12m,2y,and 3 years and radiographically at 3m,9m, 2y,and 3 years. One operator will undertake all treatments, clinical reviews and standardised radiographic exposures. Radiographic analysis will be carried out by two calibrated experienced clinicians. Standardised photographs will be taken at 3m,12m,2y,and 3 years and crown colour changes will be assessed using a standardised validated methodology.
详细描述
Aims of the pilot study:
Primary:
- Study the clinical and radiographic success of Regenerative Endodontic Technique for the regeneration/revascularisation of immature permanent teeth with necrotic root canal systems following a traumatic injury.
- Study the qualitative and quantitative increase in root dimensions, following RET, by evaluating continued root development and thickening of dentinal walls.
Secondary:
Evaluate effect of treatment on colour change of the treated tooth compared with the healthy contralateral tooth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Single group so no masking
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 6-16 years of age
- •Patients who are fit and healthy or with an ASA1 or ASA2 medical conditions
- •Patients with cooperation level that would allow treatment under local analgesia
- •Patients with a traumatised permanent incisors, canines or premolars having at least one of the following:
- •Necrotic or partially necrotic root canal systems.
- •Periapical periodontitis/abscess.
- •Sinus tract.
- •Patients with permanent incisors, canines or premolars that have incomplete root formation with open apices.
排除标准
- •Patient older than 16 year of age
- •Patients allergic to Ciprofloxacin, Metronidazole.
- •Patients with medical conditions and/or receiving medications that would affect patients' body's ability to heal such as diabetic patients or ability of the patients' blood to clot such as patients with Von Willebrand's disease.
- •Patients with risk of developing infective endocarditis or immune compromised patients.
- •Patients with non traumatised non-vital permanent incisors, canines or premolars where root development already deemed to be completed.
- •No concurrent signs of other pathological root resorption, such as replacement root resorption, which could otherwise affect the prognosis of the tooth.
- •Uncooperative patients.
结局指标
主要结局
Change in root length
时间窗: Month 3, Month 9, Year 2, and year 3.
Root length from cement enamel junction to radiographic apex measured over time
Change in root dentinal wall width
时间窗: Month 3, Month 9, Year 2, and year 3.
Root dentinal width measured radiographically at 2/3 root length over time
Change in apical foramen width
时间窗: Month 3, Month 9, Year 2, and year 3.
Apical foramen width measured radiographically over time
Change in periodontal healing
时间窗: Month 3, Month 6, Month 9, Year 2, and year 3.
Absence of signs and symptoms of infection over time
次要结局
- Change in crown Colour(Month 3,Month 12, year 2, and year 3.)