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临床试验/CTRI/2024/02/062861
CTRI/2024/02/062861尚未招募4 期

Comparative Evaluation Of MTA, Emdogain and Human Biological Membrane As a Pulpotomy Agents in Permanent Teeth With Irreversible Pulpitis: A Randomized Controlled Study

Zoya Kidwai1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2024年2月25日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
42
试验地点
1
主要终点
To Check For Vitality Of the Tooth With No Clinical Signs Of Pain and Sensitivity After Using MTA, Emdogain Gel And Human Amniotic Membrane As A Pulpotomy Agents

研究概览

简要总结

It has long been assumed that permanent teeth with "irreversible pulpitis" have dental pulp that has been irreparably injured, is beyond repair, and requires root canal therapy.1The tooth’s survival time is dramatically shortened by this operation. Attempts have been made to use pulpotomy as a therapy strategy in permanent teeth with complete root development presenting symptoms of irreversible pulpitis, where radicular pulp is still healthy, in recognition of the intrinsic healing capacity of an infection-free pulp. The essential pulp should be preserved because it is crucial for induction, formation, nutrition, defence, and sensation in addition to other functions.

In order to treat teeth with pulpitis, pulpotomy, a minimally invasive and biologically based technique, has come back into use. It entails the removal of the coronal portion of the vital pulp in order to preserve the vitality of the remaining radicular region. Devitalization, preservation, and regeneration are the three categories under which pulpotomy can be categorized according to therapeutic goals. There has been a significant increase in interest in regenerative endodontics with the development of mineral trioxide aggregate (MTA).Current innovations include regeneration materials that are antimicrobial, biocompatible, and bioinductive that have been known to stimulate pulp cell regeneration, redirect the inflammatory response, and improve the healing capacity of the remaining healthy vital pulp. MTA is regarded as one of the most widely utilized calcium silicate cements used for this purpose on the basis of evidence demonstrating successful clinical outcomes.It has many benefits over other traditional endodontic materials, such as superior sealing ability, biocompatibility and the capacity to construct a dentin bridge in pulp capping and pulpotomy situations.

Amelogenins, a class of proteins known to stimulate the growth and proliferation of periodontal ligament cells (PDL), are a major component of another regenerative material, enamel matrix derivative (EMD, Emdogain®), which has been supported for the regeneration of dental tissues.

Human Biological Membrane is a novel material with substantial stem cell reserves, and they are now gaining prominence among regenerative materials. Its growth factors replicate the stem cell niche for ex vivo growth and offer a natural healing environment. Its natural characteristics include low immunological response, low toxicity, and the capacity to encourage cellular proliferation and attachment. In an era of minimally invasive dentistry, pulpotomy is now increasingly being considered for the management of teeth with irreversible pulpitis and is now being reinvestigated as a definitive treatment option for mature permanent teeth presented with irreversible pulpitis. Therefore, the focused question for this study is: Does using MTA, EMD and Human derived biological membrane in pulpotomy result in better clinical & radiographic outcomes.

Aims and OBJECTIVES

To compare and evaluate the use of MTA, Emdogain and Human biological membrane as pulpotomy agents in permanent teeth with irreversible pulpitis

MATERIAL AND METHODS:

The present study will be conducted in the Department of Conservative Dentistry and Endodontics, Faculty of Dental Science, king George’s medical University, lucknow.

Patient of age group 15 to 45 years with cariously exposed mature permanent teeth will be randomly allocated into 3 groups. Interventional pulpotomy using MTA, EMDOGAIN & HUMAN BIOLOGICAL MEMBRANE will be done in GRP1, 2 & 3 respectively. Clinical and radiographic evaluation will be done at 1 month, 3 months and 6 months.

Data obtained will be statistically analyzed. Any changes deemed in the interest of the study will

be done accordingly.

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 45.00 Year(s)(—)
性别
All

入选标准

  • I Clinical inclusion criteria:
  • Patients with in range of 18 to 45 years of age.
  • Patients presented with deep carious lesions including the first and second permanent molars.
  • No evidence of any clinical pathology · no mobility and had no tenderness to percussion.
  • II Radiographic inclusion criteria:
  • Pre-operative radiographs with no evidence of external or internal root resorption.
  • Absence of furcal radiolucency.
  • Absence of periapical radiolucency or widened periodontal ligament space
  • No more than one-third root resorption detected.

排除标准

  • Patient with systemic diseases like diabetes mellitus, hypertension, hepatitis, human immunodeficiency virus, bone disorders, autoimmune disorders.
  • Patient with Periodontally compromised teeth.
  • Pregnant Females.

结局指标

主要结局

To Check For Vitality Of the Tooth With No Clinical Signs Of Pain and Sensitivity After Using MTA, Emdogain Gel And Human Amniotic Membrane As A Pulpotomy Agents

时间窗: At 1 month,3 months and 6 months

次要结局

  • To Check For Any Radiographical Signs Of Disease Progression like Periapical Lesion Formation Or Periodontal Widening After Using MTA, Emdogain Gel And Human Amniotic Membrane As A Pulpotomy Agent(At 1 month,3 months and 6 months)

研究者

发起方
Zoya Kidwai
申办方类型
Other [Self Sponsored]
责任方
Principal Investigator
主要研究者

Zoya Kidwai

Faculty Of Dental Sciences, King Georges Medical University, Lucknow

研究点 (1)

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