跳至主要内容
临床试验/CTRI/2025/02/080563
CTRI/2025/02/080563尚未招募Phase 3 4

Comparing the Efficacy of Various Direct Pulp Capping Agents on Dentin Bridge Formation – A Clinical Study.

Agarwal Namrata1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年2月27日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
The volume of dentin bridge formed after direct pulp capping with Platelet RichFibrin, Propolis extract, Simvastatin gel and MTA

研究概览

简要总结

The participants reaching the inclusion criteria are selected. After obtaining informed consent, the direct pulp capping procedure is initiated with the administration of local anesthesia and the placement of rubber dam isolation. Carious lesions are thoroughly excavated, and upon pulp exposure, if hemostasis is achieved, appropriate pulp capping agents are applied. There are four pulp capping agents- MTA , Platelet rich fibrin, Simvastatin hydrogel and Propolis hydrogel.

For preparation of PRF-   The patients’ blood will be collected without anticoagulant and the tube will be placed immediately after collection into the centrifuge for 12mins at 2700 rpm. The intermediate layer obtained will be placed on the pulp exposure.

For preparation of propolis hydrogel-   Maceration of 500 grams of raw propolis will be done with 500ml of 96 % ethanol in a closed container for 14 days. The brown extract obtained will be mixed with poloxamar and methylcellulose to form a hydrogel

For preparation of simvastatin hydrogel- Pure simvastatin will be obtained. 1.2% Simvastatin hydrogel will be prepared by mixing with poloxamar and methylcellulose.

The pulp capping agents will be placed on the exposed pulp, a layer of glass ionomer cement will be applied and permanent restoration will be done with composite.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • Asymptomatic maxillary and mandibular molars with caries.
  • No tenderness to percussion.
  • Ideal periodontal probing depth of 2 to 3 mm.
  • Normal response to cold and electric pulp testing.
  • Radiographic evidence of deep caries approximating the pulp chamber with no evidence of thickening/ widening of periodontal ligament.
  • Absence of furcation radiolucencies and periapical pathology.

排除标准

  • Symptomatic teeth (history of spontaneous pain).
  • Radiographic evidence of periapical changes or pathology.
  • History of systemic diseases.
  • Tooth not conducive for rubber dam isolation.
  • History of previous restoration in the tooth under consideration for pulp capping.
  • Periodontally compromised teeth.
  • Patients with bleeding disorders.
  • Patients with unsatisfactory oral hygiene maintenance.
  • Pregnant and lactating females.
  • Uncooperative patients.

结局指标

主要结局

The volume of dentin bridge formed after direct pulp capping with Platelet RichFibrin, Propolis extract, Simvastatin gel and MTA

时间窗: 3months,6months,12months

次要结局

  • Clinical response to the direct pulp capping agents(3months,6months,12 months)

研究者

发起方
Agarwal Namrata
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Agarwal Namrata

Army college of Dental Sciences

研究点 (1)

Loading locations...

相似试验