跳至主要内容
临床试验/CTRI/2024/10/075900
CTRI/2024/10/075900尚未招募不适用

Impact of caries initiation site on the efficacy of Vital Pulp Therapy in Mature Mandibular Molars with Symptomatic Irreversible Pulpitis :A Prospective Clinical Study

Not Applicable1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2024年10月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
28
试验地点
1
主要终点
Clinical evaluation of the impact of caries initiation site on the vital pulp therapy

研究概览

简要总结

Dental caries is a significant global problem affecting people of all ages, necessitating intervention aimed at minimizing detrimental effects on the remaining dental pulp. Caries is a biofilm-induced disease, driven by a supply of fermentable carbohydrates. The resulting ecological shift creates an acidogenic, cariogenic niche, which breaks down dental hard tissue to form a cavity. Clinically, deep carious lesions can lead to pain, sensitivity, and the risk of pulp infection.If left untreated, caries will advance through dentine initiating pulpitis and necrosis; however, if conservatively managed, pulpal recovery occurs even in deep carious lesions. Conventionally Root canal treatment (RCT) has been considered the standard for the management of teeth with carious pulp exposure, particularly in mature teeth presenting with symptomatic irreversible pulpitis. The field of endodontics is presently undergoing a shift when it comes to the management of deep caries and exposed pulp with its focus gradually shifting towards minimally invasive biological procedures also termed Vital Pulp Therapy (VPT).

Histological studies have shown that infection is often limited to the coronal chamber of the root canal system of the cariously exposed pulp, mechanical or traumatic vital pulp exposure**.And, if the carious portion is removed and the infected pulp tissue is amputated, remaining healthy tissue can be repaired.**  Vital pulp therapy procedures are not only technically simpler but more economical, over conventional RCT. Biological characteristics of hydrophilic Calcium Silicate based Cements (CSCs) have enabled consistent successful treatment modalities for teeth with carious pulp exposure and symptoms indicative of irreversible pulpitis.

Furthermore, VPT became a recognized treatment modality by the European Society of Endodontology (ESE) and the American Association of Endodontics (AAE) by virtue of its high success rates.

Nevertheless, the age of the patient seems to plays only a minor role in treatment success.  The same applies to factors such as the sex of the patient, tooth position (posterior or anterior), and the size or location of the pulp exposure.As we are not very clear about the impact of the caries initiation site. So through this study, we are going to evaluate the impact of caries initiation site on the efficacy of Vital Pulp Therapy.

AIM AND OBJECTIVE:

Impact of Caries initiation site on the efficacy of Vital Pulp Therapy in Symptomatic Irreversible Pulpitis a Clinical and radiographical evaluation.

M MATERIAL AND METHOD:

The present study will be conducted in the Department of Conservative Dentistry and Endodontics, Faculty of Dental Science, King George’s Medical University, Lucknow.

The study will be conducted only after getting clearance from the Institutional Ethical Committee and registration in CTRI.

The study aims to include suitable number of patients with symptomatic irreversible pulpitis in mature mandibular molar teeth, who will give a written consent and adhere in the inclusion criteria of Vital Pulp Therapy will be categorized in different groups based on  caries initiation site.

Vital Pulp Therapy is done following the guidelines of European Society of Endodontics (ESE).Clinical and radiographical evaluation will be done to evaluate the efficacy of Vital Pulp Therapy at required intervals.

Data obtained will be statistically analyzed. Any changes deemed in the interest to the study will be done accordingly.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Healthy patients with No Relevant History & who will give the written consent.
  • Permanent molar with deep caries and subsequent pulp exposure.
  • Diagnosis of Symptomatic Irreversible Pulpitis.
  • Soft tissue around the tooth is normal with no swelling or sinus tract.
  • Hemostasis should be achieved after pulpotomy.

排除标准

  • Patient who denied to take part in the study.
  • Patients with systemic disease that interferes.
  • with pulp healing.
  • No hemostasis is achieved in 5-10min of pulpotomy.
  • Radiographic evidence of internal or external resorption, inter-radicular bone loss, or periapical pathology.
  • The tooth is non restorable.

结局指标

主要结局

Clinical evaluation of the impact of caries initiation site on the vital pulp therapy

时间窗: 1 month and after that at 3 months interval

次要结局

  • Radiographical evaluation of the impact of caries initiation site on the efficacy of vital pulp therapy(1 month and after that at 3 months interval)

研究者

申办方类型
Other [Not Applicable]
责任方
Principal Investigator
主要研究者

Dr Prabha Shristha

Faculty of Dental Sciences, King Georges Medical University

研究点 (1)

Loading locations...

相似试验