跳至主要内容
临床试验/CTRI/2025/01/079306
CTRI/2025/01/079306尚未招募3 期

A comparative evaluation of the clinical performance of bulk-fill and preheated bulk-fill composite resin in class I compound restorations by using custom shield technique A randomized controlled trial.

Dr shilpa Nirankari1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年2月5日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
The clinical performance of bulk fill and Preheated bulk-fill composite resin in class I compound restorations will be evaluated by two evaluators according to the Modified USPHS criteria .

研究概览

简要总结

The massive introduction of various fluoridated agents appears to have altered the morphological factor in the development of dental caries. This led to hidden carious lesions which have an intact occlusal surface and hence are occult. Nowadays for restoring such carious lesions the earlier concept of prophylactic  extension is being displaced by minimally invasive dentistry, which focuses on preserving the sound dental structure. The posterior composite resin restorations are the standard in modern dentistry, which is moving towards Biomimetic dentistry   aiming to restore the natural contour & function of the original tooth & it is also important to achieve a harmonious occlusal & cusp fossa relationship in posterior tooth cavity restoration. The direct restorations are time-consuming, technically sensitive, and may not result in correct replication of the form and occlusion. Frequently, along with occlusal surfaces, the buccal and lingual surfaces can be affected by hidden caries and be lost during caries excavation. To resolve all these problems in the class I compound lesions, Gaetano Paolone and Salvatore Scolavino and the style Italiano team introduced the custom shield technique.  This  technique utilizes putty index for recording the height and anatomy of the buccal/palatal cusp before its reduction. Restoration of natural contours using bulk-fill composite resin becomes difficult because of more viscous nature.  it does not get adapted properly to putty index. To improve the adaptation of viscous bulk-fill composite resin, preheating of bulk-fill composite resin is done. Pre-heating of bulk-fill and conventional restorative composites prior to photoactivation decreases polymerization-induced shrinkage forces without compromising the degree of conversion & improves marginal adaption.

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 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients aged between 18 to 60 years.
  • 2.Patients with class I compound lesion in permanent molars with caries score 3 & 4 of ICDAS II criteria.

排除标准

  • 1.Patients with deep carious lesions.
  • 2.Patients with compromised periodontal health.
  • 3.Patients who is medically compromised.
  • 4.Pregnant womens .
  • 6.Patients with malpositioned teeth.
  • 7.Patients sensitive to local anaesthesia & latex.
  • 8.Patients not willing to participate.

结局指标

主要结局

The clinical performance of bulk fill and Preheated bulk-fill composite resin in class I compound restorations will be evaluated by two evaluators according to the Modified USPHS criteria .

时间窗: baseline,6 months,12 months

次要结局

  • To evaluate and compare clinical performance of bulk-fill and preheated bulk-fill composite resin in class I compound restorations with ‘custom shield technique’(baseline, 6 months, 12 months)

研究者

发起方
Dr shilpa Nirankari
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Shilpa Nirankari

Government Dental College and Hospital, Nagpur

研究点 (1)

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