Regenerative Ability of Immature Necrotic Permanent Teeth Using Different Scaffolds (A Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Clinically by absence of pain and/or swelling
研究概览
简要总结
The goal of this clinical trial is to compare effect of different scaffolds on the regenerative potential of young permanent immature teeth with necrotic pulp. The main question it aims to answer is:
is there difference in regenerative potential using Hyaluronic acid and platelets rich fibrin as scaffolds in permanent immature teeth with necrotic pulp? participants will undergo regeneration protocol including hyaluronic acid and platelets rich fibrin as scaffolds Researchers will compare [hyaluronic acid , platelets rich fibrin , and no scaffold ] to see the regenerative potential
详细描述
The study will be conducted on 30 maxillary anterior teeth with open apex; with 10 maxillary anterior teeth with open apex in each group (n=10). The patient will be asked to pick an opaque sealed envelope that will contain a number from 1 to 3. The resultant number will determine in which group the participants will be placed. single blinding will be maintained in this study as the Outcomes Assessor and the patients will not be aware of their group/used scaffold Group (I) control group with no scaffold used. Group (II) using platelets rich fibrin ( PRF) as a scaffold. Group (III) using hyaluronic acid (HYA) as a scaffold.
Procedural steps:
1st visit
1.Patients will be given anesthesia with vasoconstrictor . rubber dam isolation and access will be done 2. gentle irrigation with 1.5-3% sodium hypochlorite (NaOCl) (20ml/5 mins) using needle with closed end and side-vents with needle placed 1mm from apex will be done 3.then, irrigation will be done with saline or 17% Ethylenediaminetetraacetic acid (EDTA) (20 mL/canal, 5 min) 4. The canal space will be dried using sterile paper points 5.1ml of calcium hydroxide (metapaste) will be delivered into canal space 6.Sterile cotton pellet will be inserted and access cavity will be sealed using 3-4mm of temporary restoration (Coltosol F; Coltene Whaledent, Altstatten, Switzerland) for 3 weeks.
2nd visit
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with age range from 9-20 years with no sex predilection. Systemically healthy patients.
- •Non-vital maxillary anterior presenting with or without signs and/or symptoms of periapical pathology.
- •No mobility.
- •Pocket depth less than 3 mm.
排除标准
- •Teeth with vertical fracture
- •Periodontal involved teeth and non-restorable teeth
- •Lack of patient cooperation
研究组 & 干预措施
hyaluronic acid
hyaluronic acid will be delivered by syringe into canal
干预措施: hyaluronic acid (Procedure)
platelets rich fibrin
PRF is used as Scaffold by placing the compressed PRF membrane into canal
干预措施: Platelet rich fibrin (Procedure)
no scaffold
initiate bleeding using hand files size beyond apex with sharp strokes
干预措施: no scaffold (Procedure)
结局指标
主要结局
Clinically by absence of pain and/or swelling
时间窗: 1 year
absence of pain is measured clinically by absence of pain in response to percussion and palation in relation to the related tooth
absence or change of periapical radiolucency.
时间窗: 1 year
absence or change of periapical radiolucency is measured by standardized radiographs (paralleling technique every 3 months and cbct after 1 year)
次要结局
- measuring different root parameters(1 year)
研究者
Mai Osama
Principal investigator, Teaching assistant, Endodontic department, Faculty of dentistry, Ainshams University
Ain Shams University