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临床试验/NCT03409887
NCT03409887已完成不适用

Effect of Intraorifice Barrier on Healing of Apical Periodontitis: A Randomized Clinical Study

Postgraduate Institute of Dental Sciences Rohtak0 个研究点目标入组 75 人开始时间: 2016年10月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
75
主要终点
Clinical success

研究概览

简要总结

Based on various in-vitro studies intraorifice barrier has been suggested as an effective mean to provide seal against coronal microleakage. This study intends to clinically investigate efficacy of intraorifice barrier in healing of apical periodontitis.

详细描述

INTRODUCTION

Coronal leakage is considered significant factor for failure of endodontic treatment. In an array of retrospective studies significant number of cases were reported of apical periodontitis in teeth with unsatisfactory coronal seal as compared to the ones with clinically/radiographically acceptable coronal restoration. Gutta-percha and sealer alone used routinely as root canal obturating material is found to be ineffective to guard against microleakage. Even clinically acceptable root filling allow penetration of bacteria and their products in as less as three days and contribute to eventual treatment failure. This breach of seal in coronal segment of obturated root canal may significantly jeopardize endodontic treatment outcome.

Roghanizad suggested placement of intraorifice barrier to augment coronal seal in endodontically treated teeth. In his study teeth with intraorifice barriers leaked significantly less than the control group where no such barrier was placed. Since then numerous studies have established supremacy of intraorifice barrier and sealing of floor of pulp chamber in preventing coronal microleakage than the one without it. Various materials have been tested as intraorifice barrier. Some studies have reported no difference amongst materials.while other found better performance of MTA over composite and GIC ; GIC over Polycarboxylate cement and Flowable composite.and resilon also composite was found superior over MTA and Cavit and Cavit and IRM.

Various methodology has been employed to study coronal microleakage viz dye penetration ; bacterial penetration ; fluid filtration and glucose molecule penetration.

Intraorifice barrier apart from enhancing probability of success of endodontic treatment may also augment periodontal therapy as intra pulpal infection is known to contribute in worsening of periodontal health by promoting marginal bone loss and pocket formation. Importance of base has also been stressed by Hommez et al who in retrospective study found higher incidence of apical periodontitis in cases where base was absent even though endodontic treatment was adequate.

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Mature permanent mandibular molars.
  • Pulpal necrosis as confirmed by negative response to pulp sensibility test (cold and electric pulp test) ;
  • Radiographic evidence of apical periodontitis in the form of periapical radiolucency (size not more than 2 × 2mm);

排除标准

  • Younger than 18 years;
  • Pregnant, diabetic, or immunocompromised;
  • Having a positive history of antibiotic use within the past month or require antibiotic premedication for dent treatment (including infective endocarditis or prosthetic joint prophylaxis);
  • Teeth having previous root fillings, unrestorable teeth, fractured/perforated roots, grade 3 mobility, and his of recent periodontal therapy (within previous 6 months);

研究组 & 干预措施

Base Group

Experimental

Base of GIC

干预措施: Base of GIC (Procedure)

Intraorifice Group

Experimental

Intraorifice barrier of GIC.

干预措施: Intraorifice barrier of GIC (Procedure)

Control Group

Active Comparator

Direct composite restoration

干预措施: Direct composite restoration (Procedure)

结局指标

主要结局

Clinical success

时间窗: Baseline to one year

Success was defined as absence of signs and symptoms

次要结局

  • Radiographic Success(Baseline to one year)

研究者

申办方类型
Other
责任方
Sponsor

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