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临床试验/NCT06171776
NCT06171776进行中(未招募)2 期

Evaluation of Conservative Management of Teeth With Deep Cavitated Carious Lesions Using Three Different Lining Materials-a Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
进行中(未招募)
入组人数
90
试验地点
1
主要终点
postoperative pain (binary)

研究概览

简要总结

The goal of this clinical trial is to compare postoperative pain of calcium silicate cement and resin-based tricalcium silicate (TheraCal LC) versus chemically Cured Glass Ionomer cement (FujiXI) in conservative management of very deep carious lesions by selective caries removal

详细描述

p-Patients having Permanent posterior teeth with very deep carious lesions I 1 calcium silicate cement I 2= resin-based tricalcium silicate (TheraCal LC) C- chemically Glass Ionomer cement O- Outcome name Measuring Device Measuring Unit Primary1ry postoperative pain 1- Refrigerant spray (endo frost ) 2- Percussion (Marchi et al. 2006) 3- Palpation Binary Secondry2ry Peri-apical pathosis Digital radiograph (Hashem et al. 2015) Binary

T- one month, three months, six months,12 months,24 months evaluation S-Randomized clinical trial 7- Trial design: Randomized Controlled Trial. Trial type: single blind parallel arms design Trial framework: Equivalence frame, Allocation ratio: 1:1. Research question In patients having permanent posterior teeth with very deep carious lesions will calcium silicate cement or resin-based tricalcium silicate (TheraCal LC) in comparison to chemically cured glass ionomer cement result in clinical and radiographical success? Methods: Participants, interventions, and outcomes 8-Study Settings: This clinical trial will be held in the Faculty of Oral & Dental Medicine Cairo University, Egypt.

9- Eligibility criteria:

  1. Eligibility Criteria of participants:

Inclusion Criteria of participants:

  1. Patients male or female older than 18 y in good general health
  2. A minimum of 1 deep carious lesion penetrating three-quarters or more into the dentine as identified with the periapical (PA) radiograph; Clinically according to International Caries Detection and Assessment System (ICDAS II) score 4
  3. Clinical symptoms of reversible pulpitis
  4. Positive pulp response to electric pulp test or thermal stimulation
  5. No PA changes viewed on PA radiograph

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients male or female older than 18 y in good general health
  • A minimum of 1 deep carious lesion penetrating three-quarters or more into the dentine as identified with the periapical (PA) radiograph; 3-Clinically according to International Caries Detection and Assessment System (ICDAS II) score 4 (Clinical symptoms of reversible pulpitis)
  • Positive pulp response to thermal stimulation (cold test)
  • No PA changes viewed on PA radiograph

排除标准

  • 1-Clinical symptoms of irreversible pulpitis requiring endodontic treatment
  • Presence of fistulas or swelling
  • Mobile teeth or tenderness to percussion
  • Anterior teeth with aesthetic concerns
  • Pregnant women, in view of requirements for radiographs
  • Patients younger than 18 y
  • Patients unable to give consent

研究组 & 干预措施

fuji XI

Active Comparator

chemically cured glass ionomer

干预措施: Fuji IX (Drug)

RetroMTA

Experimental

cacium silicat cement

干预措施: RetroMTA (Drug)

Theracal LC

Experimental

resin based calcium silicate cement

干预措施: TheraCal (Drug)

结局指标

主要结局

postoperative pain (binary)

时间窗: one week to 24 months

pain after restoration of teeth using cold test

次要结局

  • periapical pathosis detection using digital periapical radiograph(one week to 24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Omnia Magdy Moustafa

Lecturer of esthetic and conservative dentistry, faculty of dentistry, Cairo University, Egypt

Cairo University

研究点 (1)

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