跳至主要内容
临床试验/CTRI/2024/09/073481
CTRI/2024/09/073481招募中4 期

Outcome of full pulpotomy compared to root canal treatment in cariously exposed mature permanent teeth with signs of symptomatic irreversible pulpitis and apical radiolucency: A randomized controlled trial.

未提供1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2024年9月16日最近更新:

试验速览

阶段
4 期
状态
招募中
入组人数
86
试验地点
1
主要终点
Absence of clinical signs and symptoms with healing or reduction in size of apical radiolucency amonst the two groups

研究概览

简要总结

The present prospective randomized parallel group active controlled trial will be conducted comparing two treatment modalities i.e. full pulpotomy and root canal treatment. With better understanding of the healing capacity of tooth pulp and advancement in bioactive materials having regenerative potential, vital pulp preservation techniques are being practised in recent times. These techiques were previoulsy restricted to primary teeth or as an emergency treatment before root canal treatment. But recent randomized clinical trials and epidemiological studies have found it to be sucessful in permanent teeth too. Also histological studies have shown that often there is selective inflammation with involvement of coronal pulp while the radicular pulp still has the ability to repair. The standard treatment of deep carious lesion involving pulp with signs and symptoms of irreversible pulpitis and apical radiolucency is root canal treatment. Thus, the aim of present study is to compare clinical and radiographic outcome of full pulpotomy (newer treatment) with gold standard root canal treatment (standard).

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 59.00 Year(s)(—)
性别
All

入选标准

  • Healthy adult patients with extremely deep carious first and second mature permanent molars will be included.
  • Radiograph showing apical radiolucency with periapical index score of less than or equal to 4.

排除标准

  • Patients having systemic disease, pregnant, immunocompromised,habit of smoking.
  • Teeth with mobility,deep periodontal pocket, swelling,sinus tract, fracture or previously initiated treatment.Third molars will be excluded.
  • Teeth in which haemostasis will not be achieved within 10minutes with damped cotton soaked with sodium hypochlorite.
  • Absence or inaequate bleeding from of bleeding from pulp canals suggesting progressive pulp necrosis.

结局指标

主要结局

Absence of clinical signs and symptoms with healing or reduction in size of apical radiolucency amonst the two groups

时间窗: 1 year

次要结局

  • Postoperative pain reduction using VAS scale and analgesic intake.(During 1 week postoperatively and during followup visits.)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr Mohit Galani

All India Institute of Medical Sciences (AIIMS), Rajkot

研究点 (1)

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