Assessment of clinical and radiological effectiveness of inert collagen sponge saturated by Proanthocyanidin and Polyamidoamine calcium phosphate nanoparticles as a biomaterial on indirect pulp capping compared with MTA in Primary teeth: A Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The primary outcome of the trial is to assess the clinical success (absence of pain, infection, or symptoms) and radiological success (no radiolucency, root resorption, or abnormal development) of an inert collagen sponge saturated with Proanthocyanidin and Polyamidoamine calcium phosphate nanoparticles compared to MTA for indirect pulp capping in primary teeth.
研究概览
简要总结
this randomized clinical study comparing the clinical and radiological effectiveness of an inert collagen sponge saturated with Proanthocyanidin and Polyamidoamine calcium phosphate nanoparticles versus MTA for indirect pulp capping in primary teeth. The primary aim is to assess the success in terms of symptom relief and radiological outcomes, such as the absence of infection or resorption. Secondary outcomes include pulp vitality, dentin bridge formation, tooth survival rates, inflammatory response, and patient-reported satisfaction. The trial seeks to evaluate the potential of Proanthocyanidin and plyamidoamine calcium phosphate nanoparticle as a biomaterial alternative for preserving pulp health in pediatric dental care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 6.00 Year(s) 至 9.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Teeth with active deep caries on the occlusal or proximal surfaces with a history of dull, reversible pain, or mild discomfort on chewing were included in the study.
- •On radiographic interpretation, caries depth should be greater than two‑third of dentin thickness approaching pulp with no radiolucency in the periapical or furcation area of the teeth are included in the study.
排除标准
- •1.Patients with systemic diseases 2.uncooperative child
- •Teeth exhibiting signs of irreversible pulpitis such as spontaneous pain, pain on percussion, mobility, sinus tract, abscess, widened periodontal spaces, interrupted lamina dura, pulp involvement, or radiographic evidence of periapical or furcational radiolucency.
结局指标
主要结局
The primary outcome of the trial is to assess the clinical success (absence of pain, infection, or symptoms) and radiological success (no radiolucency, root resorption, or abnormal development) of an inert collagen sponge saturated with Proanthocyanidin and Polyamidoamine calcium phosphate nanoparticles compared to MTA for indirect pulp capping in primary teeth.
时间窗: baseline,3 months, 6 months
次要结局
- The secondary outcomes of the trial include evaluating pulp vitality, dentin bridge formation, and the survival rate of treated teeth, along with any inflammatory response and patient-reported outcomes such as discomfort or satisfaction.
研究者
Dr Punit Fulzele
Sharad Pawar Dental college and Hospital, DMIHER