كفاءة الدعامات و هيبوكلوريت الصوديوم مجتمعة في التجديد اللبى للأسنان الغير مكتملة
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- diameter of periapical radiolucency
研究概览
简要总结
The aim of the study is to evaluate the efficacy of combinations of different scaffolds (blood clot, platelet rich fibrin, collagen) and sodium hypochlorite concentrations (0.5%- 2.5%) in regenerative endodontics of immature non-vital anterior teeth clinically and radiographically using cone-beam computed tomography.
详细描述
Patients will be divided randomly into six equal groups (n=8)
- Group I: BC scaffold and 0.5% concentration of NaOCl irrigant solution.
- Group II: BC scaffold and 2.5% concentration of NaOCl irrigant solution.
- Group III: PRF scaffold and 0.5% concentration of NaOCl irrigant solution.
- Group IV: PRF scaffold and 2.5% concentration of NaOCl irrigant solution.
- Group V: Collagen scaffold and 0.5% concentration of NaOCl irrigant solution.
- Group VI: Collagen scaffold and 2.5% concentration of NaOCl irrigant solution.
CBCT image will be obtained for baseline records after placement of the final resin restoration then the patients will be recalled after 6 months and 12 months for evaluating any changes in root length, root canal width, apex diameter and lesion size if present. The success rates for patients at each recall visit will be scored as follows
- Score 0: Persistence of clinical and radiographic findings.
- Score 1: Absence of swelling, drainage and pain along with radiographic evidence of osseous healing + no evidence of increased root dimensions.
- Score 2: Absence of swelling, drainage and pain along with radiographic evidence of osseous healing + radiographic root development.
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)
盲法说明
Double (Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Patients, abarantly free from any systemic diseases that may hinder the normal healing process.
- •Maxillary traumatized or cariously exposed immature anterior teeth.
- •Clinical signs of pulp necrosis.
- •Radiographic evidence of incomplete root development based on an apical opening >1 mm.
排除标准
- •• Allergy to medication used in the procedure or any medical conditions that contraindicate endodontic treatment (eg, acute systemic disease and abnormalities in host defense).
- •Non-restorable tooth.
- •Radiographic evidence of root fracture.
- •Lack of patient and parent cooperation.
- •Teeth with vital pulps and complete root development.
- •Presence of periodontal pocket > 4 mm.
结局指标
主要结局
diameter of periapical radiolucency
时间窗: 1 year
radiographic changes in root
diameter of root length
时间窗: 1 year
radiographic changes in root
次要结局
- Pain scale(1 year)
- visual changes in discoloration(1 year)
研究者
Hanan Mohamed Arb
Assistant professor in Endodontic department Tanta University
Tanta University