Clinical and Radiographic Assessment of Platelet Rich Fibrin and Mineral Trioxide Aggregate as Pulp Capping Biomaterials: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- clinical success rate
研究概览
简要总结
eligible carious teeth with exposed pulp by the undergraduate students will be randomly divided into two groups to be treated with direct pulp capping (A), where (A1) represents the comparator group where teeth will be treated with direct application of MTA over the exposed pulp, (A2) represents teeth to be treated with the application of PRF directly over exposed pulp followed by MTA application. clinical and radiographic assessment of tooth vitality, history of pain, pain on percussion, and dentin bridge formation will be performed at baseline, 6 months, and 1 year
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient aged 15:40 years old.
- •Patients exhibiting pulp exposure (carious, traumatic, or mechanical) during management of active carious lesions with less than 2 mm of carious exposure.
- •Signs and symptoms indicative of pulp vitality, i.e. a positive response to thermal stimulation during a cold test.
- •periapical radiograph showing closed apex and normal periapex
排除标准
- •Teeth with spontaneous pain or sensitivity to percussion (signs of irreversible pulpitis).
- •Teeth with periodontal lesions, internal or external root resorption, calcified canals, mobility of tooth, sinus opening, or abscessed tooth.
- •Non restorable tooth.
- •Radiographic examination revealed, interrupted or broken lamina dura, widened periodontal ligament space, periapical radiolucency.
- •Pulp bleeding that could not be controlled within 10 minutes using 2.5% sodium hypochlorite
- •Immune-compromised patients or with systemic medical disorders.
- •pregnant females
研究组 & 干预措施
PRF along with MTA
5 ml of the participant blood will be drawn into 10 ml test tubes without an anticoagulant and centrifuged immediately .centrifugation will be done using a tabletop centrifuge for 10:12 min at 2700:3000 rounds per minute. The resultant product will exhibit three layers. platelet-poor plasma at the surface, PRF clot in the middle, and red blood cells at the bottom. Sterile tweezers inserted into a test tube to retrieve the PRF clot. The prepared fibrin membrane will be gently packed over the pulp
干预措施: direct pulp capping (Other)
MTA direct pulp capping
MTA is primarily calcium oxide in the form of tricalcium silicate, dicalcium silicate and tricalcium aluminate. Bismuth oxide is added for radiopacity, MTA is considered a silicate cement rather than an oxide mixture, a so its biocompatibility is due to its reaction products. MTA elevates the expression of transcription factors, induces dentin bridge formation, possesses biocompatibility9, and sustains a high pH for a longer duration and a close physiochemical seal with dentin that forms an insoluble barrier to prevent microleakag
干预措施: direct pulp capping (Other)
结局指标
主要结局
clinical success rate
时间窗: 1 year
pulp vitality by thermal pulp testing
clinical success rate
时间窗: 6 months
pulp vitality by thermal pulp testing
次要结局
- radiographic assessment of incidence of regenerative dentin (dentin bridge)(1 year)
研究者
Rahma Ahmed Ibrahem Hafiz
assisstant lecturer- faculty of dentistry- beni suef university
Cairo University