Evaluation of Conservative Management of Teeth With Deep Cavitated Carious Lesions Using Three Different Lining Materials-a Randomized Clinical Trial
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:
- Eligibility Criteria of participants:
Inclusion Criteria of participants:
- 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; Clinically according to International Caries Detection and Assessment System (ICDAS II) score 4
- Clinical symptoms of reversible pulpitis
- Positive pulp response to electric pulp test or thermal stimulation
- 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
- 是
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
chemically cured glass ionomer
干预措施: Fuji IX (Drug)
RetroMTA
cacium silicat cement
干预措施: RetroMTA (Drug)
Theracal LC
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
Omnia Magdy Moustafa
Lecturer of esthetic and conservative dentistry, faculty of dentistry, Cairo University, Egypt
Cairo University
