跳至主要内容
临床试验/CTRI/2023/11/059706
CTRI/2023/11/059706尚未招募3 期

Molecular Approaches to develop Objective Diagnostic Tools in Vital Pulp Treatment

Manipal College of Dental Sciences1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年11月27日最近更新:

试验速览

阶段
3 期
状态
尚未招募
入组人数
120
试验地点
1
主要终点
Vitality of pulpotomised tooth

研究概览

简要总结

This prospective study aims to revolutionize vital pulp treatment decisions by investigating biological markers in healthy and inflamed human pulp tissue. The research seeks to establish threshold levels of MMP-9 to guide treatment choices.

 The significance of this study lies in addressing the controversy surrounding pulp exposure from trauma or caries. Current practices vary, with many opting for root canal treatment. Inflammation of dental pulp, pulpitis, results from microbial infection, primarily due to caries or trauma. Precise assessment of pulp inflammation is pivotal for successful Vital Pulp Treatment (VPT), yet data on ideal marker levels are scarce.

 This four-year study involves 120 participants and collaboration across multiple departments. Biological material collection includes blood samples. Statistical analysis will determine marker levels and their significance.

 The procedure involves blood sample collection, followed by marker detection. Post-operative evaluation after one year will ascertain treatment success. This study’s primary outcome is a composite measure of pain absence, apical periodontitis absence, and internal root resorption absence at one year. Secondary outcomes include absence of pain at 3 and 7 days post-operatively, tooth structural integrity, and correlation of MMP-9 levels with treatment outcomes.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Adult patients with a healthy unrestored sound tooth premolars or molars with no signs of resorption or periodontal disease that is indicated for extraction for orthodontic purposes Adult patients presenting with a deep or extremely deep carious lesion radiographically reaching close to the pulp inner quarter of dentine and signs and symptoms ranging between mild moderate and severe pain Positive response to cold and electric pulp sensibility test and pulpal exposure during non selective removal of caries.

排除标准

  • More than 3mm periodontal probing depth for tooth of interest Severe case of pulpitis where time taken to achieve haemostasis is more than 10mins Necrotic pulp Systemic conditions like Bleeding disorders uncontrolled hypertension diabetes patients on anticoagulant therapy.

结局指标

主要结局

Vitality of pulpotomised tooth

时间窗: 1 year

次要结局

  • Levels of biomarkers in pulp tissue(1 year)

研究者

申办方类型
Research institution and hospital

研究点 (1)

Loading locations...

相似试验

Evaluation of levels of Biomarkers in different... | 临床试验