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临床试验/CTRI/2025/05/086504
CTRI/2025/05/086504尚未招募Phase 3 4

Evaluation of the optical behaviour and marginal discoloration of a single shade resin composite with a chameleon effect - A Randomized clinical trial

Dr BHARGAV PATEL1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2025年6月16日最近更新:
适应症

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
35
试验地点
1
主要终点
USPHS CRITERIA, COLOR MATCHING

研究概览

简要总结

This study involves 35 patients, each receiving two Class I posterior composite restorations using a split-mouth design. One side will be treated with Omnichroma composite (test group), and the other with Tetric-N-Ceram (control group). A total of 70 cavities will be evaluated. Standard clinical procedures, including case history, radiographic and vitality assessments, and shade selection (for control group), will be performed. Cavities will be prepared, etched, bonded, and filled with designated materials using layered techniques. Restorations will be finished, and after 24 hours of rehydration, color match and stability will be assessed by three blinded evaluators using USPHS criteria and magnification tools.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • 1.The Age group of 18-45 years with excellent systemic health condition.
  • 2.At least two molar or premolars with occlusal carious lesions where the size of the cavity was less than one-third of the inter- cuspal distance.
  • 3.Absence of any signs of fistula, pulp exposure, periodontal tissue swelling or abnormal tooth mobility as determined by radiographs or clinical examination.
  • 4.Patients who can maintain good oral hygiene.

排除标准

  • 1.Poor oral hygiene, recession, alveolar bone loss.
  • 2.Heavy smokers, parafunctional habits such as bruxism or traumatic occlusion.
  • 3.Natural opposing teeth with existing restorations.
  • 4.Teeth with very deep carious lesion.
  • 5.Patient taking antibiotic medications within the last 1 Week or the use of analgesics.
  • 6.Medically compromised patients, pregnant women and therapeutic radiation to the head and neck region.

结局指标

主要结局

USPHS CRITERIA, COLOR MATCHING

时间窗: 1 year

次要结局

  • COLOR MATCHING(1 year)

研究者

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

Dr BHARGAV PATEL

Government Dental College and Hospital Jamnagar

研究点 (1)

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