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临床试验/NCT01730287
NCT01730287Unknown2 期

Effect Of Different Lining Materials on Clinical Symptoms of Stepwise Excavation Without Re-enter: Double Blind Randomizd Clinical Trial

Azad University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
发起方
入组人数
100
试验地点
1
主要终点
Pulpal Vitality

研究概览

简要总结

Deep carious lesions will encounter the dentist with the challenge of selecting a treatment method that could avoid the pulpal exposure and maintain the pulp vitality.Conventional restorative treatments suggest complete removal of the caries in one visit which could cause pulpal exposure in 53% of the cases which in next step needs pulpotomy, pulpectomy or Root Canal Therapy (RCT).

Stepwise Excavation(SE)is an old concept but has been researched recently to reduce the possibility pulpal exposure during the removal of the lesion. Contrary to Indirect Pulp Capping (IPC), in this technique only the central infected part of the caries is removed in first visit and the rest of the caries will be lined by a suitable material to suppress the remained cariogenic biomass and seal the cavity. This will help the pulp to defend and survive. After a period, the cavity is re-opened and the rest of the caries which is darker, harder and with less bacteria will be removed and the tooth is restored permanently.The aim of this study was to compare the effect of different lining materials in clinical and radiographical symptoms in stepwise excavation without re-enter after one year.

详细描述

In this randomized clinical trial of 4 lining materials have been applied in deep caries teeth in stepwise excavation. The common material which is applied as a liner over the remained caries in SE is Calcium Hydroxide(CH). There are several reports of the solubility of this liner over time which could interact with sealing of the cavity in long term. It seems that a material with antibacterial activity, good sealing ability and suitable mechanical properties could cause SE be done efficiently with good prognosis.

MTA is a biomaterial that has been introduced since 1993 with antibacterial property and good sealing ability. A New Endodontic Cement, Calcium Enriched Mixture (CEM) cement with good antibacterial effect like CH with sealing ability that is proposed to be similar to MTA according to its double sealing property. CEM cement has been suggested as a suitable material in pulp capping of permanent molars with irreversible pulpitis.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • A tooth with deep caries lesion - Tooth at risk of pulpal exposure - No pulpal , instantaneous , night pain

排除标准

  • Unbearable pain of the involved tooth- Apical radiolucency of the tooth- PDL widening

研究组 & 干预措施

Control

Experimental

No lining applied in group1.

干预措施: Control (Drug)

CEM cement

Experimental

CEM cement applied over remained caries in group4.

干预措施: CEM cement (Drug)

Mineral Trioxide Aggregate (MTA)

Experimental

MTA applied over remained caries in group3.

干预措施: Mineral Trioxide Aggregate(MTA) (Drug)

Calcium Hydroxide

Experimental

Calcium Hydroxide applied over remained caries in group2.

干预措施: Calcium Hydroxide (Drug)

结局指标

主要结局

Pulpal Vitality

时间窗: One year

Clinical symptoms, radiographic evaluation. Sensitivity to cold, hot, pressure, percussion.

次要结局

未报告次要终点

研究者

发起方
Azad University of Medical Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sepideh Banava.DDS,MS

Assist-Prof

Azad University of Medical Sciences

研究点 (1)

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