跳至主要内容
临床试验/CTRI/2024/01/061399
CTRI/2024/01/061399尚未招募2 期

To evaluate and compare the effect of translucent zirconia and lithium disilicate crown on IL- 6 and TNF- levels in gingival crevicular fluid GCF at various time intervals a split-mouth comparative pilot study.

Talke Sonali Sanjay1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2024年1月22日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
12
试验地点
1
主要终点
To evaluate & compare the effect of translucent zirconia & lithium disilicate crown on IL-6 & TNF-α levels in gingival

研究概览

简要总结

Different crown materials have been known to affect the health of the periodontium.  Dental restorations are in close contact with the oral tissues, and although systemic side effects are rarely observed, yet local inflammatory reaction or hypersensitivity may be observed sometimes.  Gingival crevicular fluid (GCF) is a physiologic transudate present in a healthy gingival crevice in a small amount that increases during periodontal inflammation and becomes an inflammatory exudate.  It is a promising diagnostic and prognostic fluid with many advantages such as site-specific, non-invasiveness and contains a wide variety of microbial and host mediators like pro-inflammatory cytokines such as IL-1 b, IL-6, IL-8, TNF-α etc. Periodontal inflammation is characterized by well-orchestrated process of host defence through leukocyte recruitment and monocyte activation. These cells have been known to release pro-inflammatory mediators and cytokines (IL-1, IL-6, and Tumour necrosis factor alpha (TNF-α) in gingival crevicular fluid (GCF), that contribute to the inflammation.  TNF-α is responsible for activation of cytokines and initiates the process of inflammation. Macrophages and T-cells secrete TNF-α, which play an important role in early induction of periodontal inflammation.  Similarly, Interleukin-6 (IL-6) also activates localized immune cells and causes gingivitis and periodontal tissues destruction. Furthermore, TNF-α may synergistically stimulate human gingival fibroblasts to enhance IL6 secretion. Elevation of both IL-6 and TNF-α causes periodontal and gingival breakdown via disturbances in lipid metabolism of cells. Increased IL-6 levels are reported in periodontitis and a significant decrease in its level following periodontal therapy indicates its role as an early disease onset biomarker for periodontal inflammation has been established. Therefore, increased IL-6 and TNF-α in seen with early inflammatory conditions like marginal gingivitis and their levels further increases in periodontal breakdown. Translucent zirconia and lithium disilicate are indirect restorative materials that are commonly used because of their high aesthetic properties, mechanical properties, flexural strength, durability and biocompatibility.Therefore, this study has been designed to evaluate and compare the effect of translucent zirconia and lithium disilicate crown on gingival biomarkers (IL-6 and TNF- α) levels in gingival crevicular fluid (GCF) at various time intervals.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

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

入选标准

  • 1.Patients requiring bilateral posterior mandibular first molar complete crowns.
  • 2.Teeth selected for crown preparation should be restorable with a minimum crown to root ratio of at least 1:
  • Restored tooth should be healthy and free from plaque and any inflammation.
  • Good oral hygiene and periodontal status with overall gingival indices criteria should be of 15% or less.
  • Full complement of teeth (excluding 3rd molars).
  • Patients who will be available for the required follow up period.
  • Patients giving positive informed consent.

排除标准

  • Pregnant and breastfeeding women.
  • Systemic disease (e.g., Diabetes mellitus, hypertension, cancer, sjogren’s syndrome, mental retardation etc).
  • Patient on medication like drug related gingival hyperplasia (e.g., Phenytoin, sodium valproate, and cyclosporine), antibiotics, steroids and non-steroidal anti-inflammatory drugs within 3 months.
  • Habitual tobacco smokers.
  • Untreated gingivitis and periodontal disease.
  • A poor oral hygiene patient will be excluded from this study.

结局指标

主要结局

To evaluate & compare the effect of translucent zirconia & lithium disilicate crown on IL-6 & TNF-α levels in gingival

时间窗: before tooth | preparation (baseline) & 1 week after the | cementation of full-coverage translucent | zirconia & lithium disilicate crown on | mandibular first molar.

crevicular fluid (GCF) on

时间窗: before tooth | preparation (baseline) & 1 week after the | cementation of full-coverage translucent | zirconia & lithium disilicate crown on | mandibular first molar.

mandibular first molar on both sides.

时间窗: before tooth | preparation (baseline) & 1 week after the | cementation of full-coverage translucent | zirconia & lithium disilicate crown on | mandibular first molar.

次要结局

  • To evaluate & compare the effect of translucent zirconia & lithium disilicate crown on IL-6 & TNF-α levels in gingival(crevicular fluid (GCF) on)

研究者

发起方
Talke Sonali Sanjay
申办方类型
Other [[self]]
责任方
Principal Investigator
主要研究者

Talke Sonali Sanjay

AIIMS DELHI

研究点 (1)

Loading locations...

相似试验