跳至主要内容
临床试验/CTRI/2025/04/084356
CTRI/2025/04/084356尚未招募3 期

Comparative Evaluation of Clinical and Radiographic Success Rates of Pro-Root MTA with KIDS E MTA as Apexification agent in Permanent immature Incisors and molars

Sourabh Ramesh Joshi1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年1月5日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
No history of post-operative pain or swelling with the treated tooth/teeth

研究概览

简要总结

When a tooth has an open apex due to dental trauma or caries, it becomes challenging to achieve a successful root filling during endodontic treatment.

Injuries resulting from trauma are frequently observed during childhood and in toddlers, with a higher susceptibility for upper front teeth to experience fractures.

The closing of the root apex occurs approximately three years after tooth eruption. In cases where the apex remains open due to injury, there may be the presence of residual living pulp tissues and some enduring apical papilla cells in the surrounding periapical tissue.

Apexification, the preferred non-surgical approach for treating necrotic immature permanent teeth, has seen various materials used over time.

Initially, the widely accepted method involved using calcium hydroxide combined with camphorated monochlorophenol to stimulate the development of the apical barrier, as proposed by Kaiser in 1964.

Nevertheless, this substance took nearly 5 to 20 months to create the necessary hard tissue barrier.

Numerous materials have been developed, assessed, and established to achieve optimal results in advanced clinical performance. Mineral trioxide aggregate (MTA) was pioneered by Mahmoud Torabinejad at Loma Linda University in California, USA. Its introduction to the dental field was initially documented by Lee and colleagues in 1993.

Mineral trioxide aggregate (MTA) serves multiple purposes in dentistry, such as functioning as a reparative substance for repairing perforations, as well as being employed in procedures like pulp capping, pulpotomy, creating an apical barrier in cases with open apex, and for retrograde filling.

There have been recent developments in the apexification procedure, where MTA serves as a primary solid block. The gap created due to material shrinkage after placement is now filled with apatite-like deposits that form during MTA maturation. This enhances MTA’s ability to resist friction against root canal walls. MTA stands out for its excellent biocompatibility, reduced cytotoxicity due to its alkaline pH, and has garnered significant attention for its superior sealing capabilities, biocompatibility, regenerative potential, and antibacterial properties. Its formulation containing calcium and phosphate ions promotes the attraction of bone-forming cells and creates a favorable environment for cementum deposition.

Moreover the cost of 1 gram of Pro-Root MTA (USA) is 10000/- , whereas the cost of 1gram E-MTA is 4000/- which is a more economical option. Considering the affordability of the treatment by the patients and Indian Dentists, it is essential to carry out trials comparing the efficacy of new material with the conventional one.

Numerous clinical studies on the use of MTA in apexification can be found in the literature. Limited literature is available comparing E-MTA with Pro Root MTA. The present study aims to evaluate the clinical and radiographic success of E MTA with Pro Root MTA as apexification agents in permanent immature incisors and molars.

研究设计

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

入排标准

年龄范围
8.00 Year(s) 至 13.00 Year(s)(—)
性别
All

入选标准

  • Childrens parent willing to give informed consent will be part of the study.
  • Children between the ages of eight and thirteen years who have sustained Ellis Class-III or IV fractures in their permanent maxillary incisors Children between the ages of eight and thirteen years who have deep carious lesion with intact tooth walls.
  • Children having Spontaneous or night pain, intraoral or extraoral swelling as clinical sign and symptom Apical diameter in the range of 0.8-1.2mm of open apex molars and incisors will be included in the study.

排除标准

  • Cariously mutilated teeth Teeth with any developmental anomaly Teeth with external or internal root resorption Teeth showing fracture line involving or extending up to the roots Teeth with root caries Teeth with cervical abrasion Teeth with severe mobility grade II or more than grade II mobility were excluded.

结局指标

主要结局

No history of post-operative pain or swelling with the treated tooth/teeth

时间窗: No history of post-operative pain or swelling with the treated tooth/teeth | Reduction in mobility of tooth

Reduction in mobility of tooth

时间窗: No history of post-operative pain or swelling with the treated tooth/teeth | Reduction in mobility of tooth

次要结局

  • Post-operative radiograph showing reduction in size of the radiolucency(No increase in size of radiolucency in post operative radiograph)

研究者

发起方
Sourabh Ramesh Joshi
申办方类型
Other [self]

研究点 (1)

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