Development of injectable platelet rich fibrin scaffold reinforced with egg shell-derived biomimetic nanohydoxyapatite seeded with stem cells from human exfoliated deciduous teeth for pulp-dentin bioengineering.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Positive response to pulp vitality, radiographic increase in root length, increased radicular dentin thickness and reduction in apical diameter would be considered as primary outcome
研究概览
简要总结
Rationale: Regenerative endodontics deals with restoration of lost pulp-dentin complex using tissue engineering concepts. Appropriate selection of components of tissue engineering triad is essential. Literature shows that Stem cells from exfoliated deciduous teeth (SHED) and Nanohydroxyapatite derived from biowaste such as egg shells(E-nanoHA) has appreciable odontogenic properties. Injectable platelet rich fibrin(i-PRF) exhibits high release of growth factors, cellular migration and can three dimensionally take the shape of the canal. This study proposes to develop a single system of i-PRF scaffold with E-Nano HA and SHED for regeneration of pulp dentin complex
Novelty*:* Development of a single-phase injectable system of tissue engineering triad utilizing biological wastes such as exfoliated deciduous teeth, egg shells for pulp-dentin regeneration.
Objectives: Primary:1. Preparation and characterization of E-nanoHA 2. Preparation of culture of stem cells derived from exfoliated deciduous teeth and to develop experimental injectable platelet rich fibrin scaffold loaded with E nano HA and seeded with SHED 3. Assesing In-vitro bioactivity and cytotoxicity of the developed scaffold using pre-clinical animal model and clinical efficacy using a double-blind randomised control trial. Secondary: To develop a technology transfer package for the newly developed scaffold
***Methods:***Microwave processed E-nanoHA prepared from egg shell, characterized using SEM, EDAX, XRD and cultured SHED cells would be seeded into the injectable fibrin scaffold. In-vitro bioactivity studies and MTT assay would be done to assess the cytotoxicity. Preclinical animal studies would be done followed by a double-blind randomised control trial comparing the developed scaffold with that of the conventional pulp regeneration method. Data collection and statistical analysis of the data would be done.
Expected Outcomes. Regeneration of pulp–dentin complex established through clinical and radiographic absence of pathology, positive pulpal response, increase in root length, radicular dentin thickness and reduction in apical diameter
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 8.00 Year(s) 至 13.00 Year(s)（—）
- 性别
- All
入选标准
- •Fractured maxillary anterior tooth presenting with symptoms of irreversible pulpitis
- •Tooth with radiographic presence of open apex (Nolla’s stages 7 and 8)
- •Radiographic evidence of apical periodontits (Ostravik’s score 3 and above)
- •Tooth testing negative for pulp vitality (Pulpal blood flow) testing using laser speckled contrast imaging system.
排除标准
- •Patients not willing to take part in the study
- •Tooth with extensive fracture of crown in which rubber dam clamp cannot be placed
- •Tooth with crown-root fracture/ root fracture
- •Clinical or radiographic presence of alveolar/ maxillofacial bone fractures
- •Tooth presenting with grade II or grade III mobility
- •Patients with known allergy to medicaments used in the study
- •Medically compromised patients with co-existing systemic/ immunocompromised conditions.
结局指标
主要结局
Positive response to pulp vitality, radiographic increase in root length, increased radicular dentin thickness and reduction in apical diameter would be considered as primary outcome
时间窗: a baseline evaluation of teh variables will be recorded and effects of the intervention will be assessed 1, 3, 6, 12, 18 and 24 months after completion of the treatment
次要结局
未报告次要终点