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临床试验/NCT07179835
NCT07179835尚未招募不适用

To Evaluate Periapical Healing Post Full Pulpotomy in Permanent Mandibular Teeth With and Without Apical Periodontitis

Postgraduate Institute of Dental Sciences Rohtak2 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2025年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
128
试验地点
2
主要终点
Success following complete pulpotomy

研究概览

简要总结

This clinical study aims to evaluate the periapical and clinical healing outcomes of full pulpotomy using MTA in mandibular permanent molars diagnosed with symptomatic irreversible pulpitis. Patients will be stratified based on the presence or absence of apical periodontitis. Clinical and radiographic assessments will be conducted at baseline, 6 months, and 12 months to compare healing outcomes between groups. The study seeks to determine the effectiveness of full pulpotomy as a less invasive alternative to root canal treatment, even in teeth with apical pathosis.

详细描述

This prospective clinical study aims to evaluate the periapical and clinical healing outcomes of full pulpotomy using mineral trioxide aggregate (MTA) in mandibular permanent molars diagnosed with symptomatic irreversible pulpitis. Patients will be stratified based on the presence or absence of apical periodontitis. Clinical and radiographic assessments will be conducted at baseline, 6 months, and 12 months to compare healing outcomes between groups. The study seeks to determine the effectiveness of full pulpotomy as a less invasive alternative to root canal treatment, even in teeth with apical pathosis.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The patient should be ≥18 years of age.
  • Restorable mature permanent 1st and 2nd Mandibular molars with extremely deep caries (≥2/3 dentine involvement)
  • Tooth should give positive response to pulp sensibility testing.
  • Radiographic finding of periapical index (PAI) score >/=3 (for test group) , score </= 2 (for control group)

排除标准

  • Teeth with immature roots.
  • No pulp exposure after caries excavation.
  • Bleeding could not be controlled in 10 minutes.
  • Signs of pulpal necrosis, sinus tract, swelling, insufficient bleeding after pulp exposure.
  • History of analgesic intake in previous 1 week, or antibiotic intake in 1 month.
  • Internal/external resorption.
  • Contributory medical history (alcoholism, smokers, diabetic, hypertension, drug dependency, Heart or valve disease, hepatitis, herpes, immunodeficiency (HIV), infectious diseases, kidney or liver, migraine)

结局指标

主要结局

Success following complete pulpotomy

时间窗: 12 MONTHS

Clinical-Radiographic Success After Full Pulpotomy in Mandibular Molars With and Without Apical Periodontitis"

Success following complete pulpotomy

时间窗: 12 MONTHS

Clinical-Radiographic Success After Full Pulpotomy in Mandibular Molars With and Without Apical Periodontitis"

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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