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临床试验/NCT06613932
NCT06613932招募中不适用

Clinical and Radiographic Assessment of L-PRF, Nanohydroxyapatite Material Combined With L-PRF Scaffold in Vital Pulp Therapy. Treatments in Mandibular First Molars With Closed Apices "Randomized Controlled Trial"

Future University in Egypt1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2023年10月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
45
试验地点
1
主要终点
post operative Pain assessment

研究概览

简要总结

Clinical and Radiographic Assessment of L-PRF, Nanohydroxyapatite material combined with L-PRF scaffold in Vital pulp Therapy. Treatments in Mandibular First Molars with Closed Apices, Randomized Controlled Trial.

详细描述

pulpotomy by using 3 materials. The first group(control group ) uses hydroxyapatite material as a pulpotomy agent, and the second group uses L-PRF as a pulpotomy agent. the third group uses combined material (L-PRF = Nano hydroxyapatite )as a pulpotomy agent .. then assesses the clinical and radiographic result of the 2 interventions group with control group

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)

入排标准

年龄范围
15 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients should be free from any systemic disease. Patients of either gender aged from 15-
  • •Patients will agree to the consent and will commit to a follow-up period. Soft tissues around the tooth are normal with no swelling or sinus tract. The tooth is restorable tooth has signs and symptoms of irreversible pulpitis of the mature root The tooth doesn't contain any internal or external resorption or periapical lesions.
  • •The tooth should give a positive response to the cold test.

排除标准

  • •Pregnant and lactating females. Patients with Mental disturbance. Patients who could/would not participate in a 6-month follow-up. A tooth with immature roots. Patients with necrotic pulp.• tooth with periapical lesions or infections. Soft tissue having fistula or swelling Homoeostasis after 10 minutes can not be controlled after total pulpotomy

研究组 & 干预措施

L-PRF combined with Nano-hydroxyapatite

Experimental

using the combined material (nanohydroxyapatite mixed to L-PRF ) and assessing the clinical and radiographic result compared to other groups

干预措施: pulpotomy (Procedure)

hydroxyapatite

Experimental

using hydroxyapatite as a pulpotomy agent and reviewing its clinical and radiographic performance compared to the other groups

干预措施: pulpotomy (Procedure)

L-PRF

Experimental

using L-PRF as a pulpotomy agent and assessing the clinical and radiographic result compared to other groups

干预措施: pulpotomy (Procedure)

结局指标

主要结局

post operative Pain assessment

时间窗: 6, 12, 24, 72hours and 7 days after treatment

Pain evaluations were conducted preoperatively with numerical rating scale ( a verbal or writing determination of a pain level on a scale from 0 to 10, in which 0 represents no pain and 10 represents excruciating pain .

次要结局

  • Dentine bridge formation(12 months post operative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nada Ayman El-Sayed Ibraim

principal investigator

Future University in Egypt

研究点 (1)

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