跳至主要内容
临床试验/CTRI/2023/12/060901
CTRI/2023/12/060901尚未招募1/2 期

Outcome of Full pulpotomy vs Partial radicular pulpotomy in mature permanent teeth indicative of Irreversible Pulpitis using Biodentine - A Randomized Controlled Trial

Faculty of Dental Sciences1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年1月5日最近更新:

试验速览

阶段
1/2 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
Healing of periapical lesion on radiographic evaluation and resolution of clinical symptoms

研究概览

简要总结

Permanent teeth diagnosed with “irreversible pulpitis” have long been implied to have an irreversibly damaged dental pulp that is beyond repair and warranting root canal treatment. However, newer clinical approaches such as pulpotomy, a minimally invasive and biologically based procedure have re-emerged to manage teeth with pulpitis.

Prevention of disease or its termination at the earliest possible stage, along with the preservation of maximum healthy viable tissue is an indispensable element of any treatment modality and forms the fundamental basis of minimally invasive dentistry. Pulpotomy is one such procedure that focuses on the preservation of pulp and its functions like proprioception, innervation and vascularisation. Compared to root canal treatment (RCT), it is less time-consuming and easier to perform technically. Teeth treated with RCT are at risk of structural failure, loss of sensation of environmental changes (potentially leading to more or worse caries), rejection of the foreign material, reinfection, and occurrence of apical periodontitis.

The rationale behind root canal obturation has inclined toward mechanical rather than biological treatment. A recent systematic review has concluded that VPTs, specifically full pulpotomy, have exhibited a high success rate in managing carious pulp exposure of cases with IP and can be a suitable potential substitute for RCT.

Despite the work to date, controversy still persists regarding the optimal level of endodontic therapy. This is partly due to the lack of distinction between pulpal inflammation and  radicular infection. Nicholls and Baume, have shown that the inflamed pulp lends itself to vital apex treatment. Therefore, to overcome the drawbacks of RCT, vital apex treatment and vital pulp therapy have been developed. Vital apex treatment may be defined as radicular pulpotomy or biopulpectomy.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
15.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Mature permanent molar Strong and prolonged reaction to cold, which can last for minutes.
  • Spontaneous dull pain that can be more or less suppressed by pain medication clinical diagnosis of irreversible pulpitis with/without periapical rarefaction.
  • No signs of pulpal necrosis including sinus tract or swelling.

排除标准

  • Non restorable teeth.
  • Negative response to thermal testing, the presence of sinus tract or swelling.
  • Bleeding could not be controlled after pulpotomy in 5 minutes.
  • Insufficient bleeding after pulp exposure, the pulp is judged necrotic or partially necrotic Medically compromised patient.

结局指标

主要结局

Healing of periapical lesion on radiographic evaluation and resolution of clinical symptoms

时间窗: 6 - 12 MONTHS.

次要结局

  • Response to thermal testing(6-12 MONTHS)

研究者

发起方
Faculty of Dental Sciences
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Vijul

Faculty of Dental Sciences IMS BHU

研究点 (1)

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