跳至主要内容
临床试验/CTRI/2024/08/072626
CTRI/2024/08/072626
尚未招募
不适用

In vivo – evaluation of a novel bioactive restorative resin in proximal restorations of primary molars- A comparative study

KHADER SHERIFF1 个研究点 分布在 1 个国家目标入组 258 人开始时间: 2024年8月28日最近更新:

概览

阶段
不适用
状态
尚未招募
发起方
KHADER SHERIFF
入组人数
258
试验地点
1
主要终点
To check the different restoration used in proximal areas of primary tooth

概览

简要总结

Restorative therapy is a part of comprehensive dental care for management ofdental caries that depends on several factors such as caries-risk assessment,

longevity and durability of the dental materials, type of restoration necessitated,

patients’ cooperation towards treatment, and development status of the

primary/permanent dentition, anticipated compliances, and other environmental

influences.

Conventional restorative procedures of extensively damaged or destroyed

carious teeth is a challenging task as removal of the tooth was the principal

mode of treatment for the primary tooth particularly at the anterior region in the

past followed by replacement with an artificial prosthetic substitute until the

eruption of permanent tooth. This may result in psychological impact on the

child by affecting the confidence and normal personality development apart

from esthetical compromise, abnormal habits and speech difficulties.

Restorative materials used in pediatric dentistry should possess specific characteristics such as biocompatibility, durability, aesthetics, and ease of use, to ensure successful outcomes. This study aims to explore a new restorative material that meets these requirements and can potentially enhance the quality of pediatric dental care.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Investigator Blinded

入排标准

年龄范围
4.00 Year(s) 至 9.00 Year(s)(—)
性别
All

入选标准

  • Apparently healthy and cooperative.
  • Children in the age range of 4 to 9 years.
  • Children with clinically detectable proximal carious lesions.
  • (ICDAS II Scores 3,4,5).

排除标准

  • Primary teeth with deep carious lesions / pain Children who are on iron supplements or any other medication that can cause discolouration of the teeth & restoration.
  • Children with special health care needs / uncooperative children / lack of compliance.
  • Children with the evidence of parafunctional habits.

结局指标

主要结局

To check the different restoration used in proximal areas of primary tooth

时间窗: 3 months interval

次要结局

  • To check the different restoration used in proximal areas of primary tooth(3 month period)

研究者

发起方
KHADER SHERIFF
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Dr ARUN E

Madha Dental College

研究点 (1)

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