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临床试验/CTRI/2025/07/090523
CTRI/2025/07/090523已完成4 期

Comparative Clinical and Radiographic Evaluation of 3Mixtatin and MTA as Pulp Capping Agents: A Randomized Controlled Trial

Malla Reddy Dental College for Women1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2025年7月21日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
38
试验地点
1
主要终点
To compare and evaluate the clinical and radiographic efficacy of 3Mixtatin and MTA when used as pulp capping agents in permanent teeth using the CBCT.

研究概览

简要总结

MTA has an enhanced non-resorbable seal over the pulp and shows the ability to induce hard tissue formation due to the release of cytokines from bone cells. Due to a few drawbacks exhibited by MTA, there is a continuous look-out for new approaches and substances that stimulate the regenerative ability of dental tissues.

Statin components are well known for their regenerative capacity. They enhance the activity of osteoblasts and decrease osteoclastic function, leading to an increase in the rate of formation of bone, and also exhibit potent anti-inflammatory properties and maintain the levels of pro-inflammatory cytokines. Assuming these properties might have a role in the regeneration of pulp and dentin, statins are used as a pulp capping agent in the form of 3Mixtatin.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant 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

  • Deep carious lesion penetrating three-quarters or more into dentine as identified with periapical (PA) radiograph; Clinically mICDAS score 4 (Banerjee and Watson 2011)
  • Clinical symptoms of reversible pulpitis.
  • Presence of at least 2/3rds of root length radiographically, & restorability of selected teeth were also confirmed.
  • Positive pulp response to electric pulp test or thermal stimulation.
  • No PA changes on PA radiographs.

排除标准

  • Signs or symptoms more severe than reversible pulpitis.
  • Radiographic evidence of pulp degeneration such.
  • widening of periodontal ligament space, internal and external resorption of the root (IRR and ERR),
  • Pulp necrosis
  • Furcal radiolucency or inter radicular bone destruction (FR/IBD) and/or
  • Periapical bone destruction (PBD).
  • Pregnant women (in view of requirements for radiographs).
  • Patients unable to give consent.

结局指标

主要结局

To compare and evaluate the clinical and radiographic efficacy of 3Mixtatin and MTA when used as pulp capping agents in permanent teeth using the CBCT.

时间窗: 1. Pre-operative PA radiograph and CBCT, followed by post-operative PA radiograph. | 2. 1 month follow-up: PA radiograph. | 3. 3 months follow-up: PA radiograph and CBCT taken. | 4. 6 months follow-up: PA radiograph and CBCT taken.

次要结局

未报告次要终点

研究者

发起方
Malla Reddy Dental College for Women
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr S Srija Mili

MALLA REDDY DENTAL COLLEGE FOR WOMEN

研究点 (1)

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