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临床试验/NCT03171376
NCT03171376已完成不适用

Effect of Coronal Extent of Obturation in Relation to Marginal Bone on Endodontic - Periodontal Lesions Without Communication: A Randomized Controlled Trial

Postgraduate Institute of Dental Sciences Rohtak0 个研究点目标入组 60 人开始时间: 2016年10月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
主要终点
Clinical success

研究概览

简要总结

Increased incidence of apical periodontitis was reported where root filling was found coronal to the marginal bone due to communication between pulp and periodontal space. It has been suggested to place intraorifice barrier in the canal to provide coronal seal. However there exists a void in literature regarding clinical validity of the termination of obturation apical to marginal bone and placement of intraorifice barrier in resolution of periapical pathology. Therefore this randomized controlled trial intends to investigate effect of coronal level of obturation on endodontic success and marginal breakdown.

详细描述

TITLE : " Effect of coronal extent of obturation in relation to marginal bone on the healing of endodontic - periodontal lesions without communication: a randomized controlled trial."

INTRODUCTION: Coronal leakage is considered significant factor for failure of endodontic treatment . To provide endodontic care of highest quality attention should be given to coronal restoration after successful completion of root canal treatment. In an array of retrospective studies significant numbers of cases were reported of apical periodontitis in teeth with unsatisfactory coronal seal as compared to the ones with clinically or radiographically acceptable coronal restoration. Post treatment restorative status and quality & extent of root filling along with preoperative periapical lesion were found to have strong effect on outcome of endodontic treatment.

Gutta-percha and sealer alone used routinely as root canal obturating material are 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 particularly in molars because of presence of accessory canals in the floor of the pulp chamber.

Placing an additional protective barrier in the coronal portion of the root canal has been recommended to minimize microleakage and facilitate healing of apical periodontitis. 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.

Many materials have been tried as intraorifice barrier like cavit, IRM, amalgam, GIC, composite resin, dentin bonding agents, MTA. Some studies have reported no difference amongst materials while other found better performance of MTA over composite/GIC ; GIC over Polycarboxylate cement/Flowable composite and resilon alone without intraorifice barrier and composite over MTA/Cavit12 and Cavit/IRM.Recent studies have advocated use of adhesive restorative material like GIC to provide adequate seal against bacterial micro leakage. Lee et al demonstrated better sealing ability of MTA over both composite and GIC in an in vitro dye infiltration experiment. Glass ionomer may provide better seal against penetration of bacteria to the periapex because of its adhesive nature and ability to bond to the sclerotic dentin found on the pulpal floor better than composite resin.

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
16 Years 至 —(Child, Adult, Older 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 × 2 mm);
  • Generalized chronic periodontitis criteria will be considered when ≥ 30% of sites will be involved with clinical attachment loss (CAL) slight = 1or 2mm, Moderate = 3-4mm, and severe ≥ 5mm.
  • Probing depth<4mm
  • Radiographic alveolar bone breakdown not more than one third of root length.

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 dental treatment (including infective endocarditis or prosthetic joint prophylaxis);
  • Teeth having previous root fillings, unrestorable teeth, fractured/perforated roots, grade 3 mobility, and history of recent periodontal therapy (within previous 6 months); and
  • Teeth with established endodontic-periodontal lesions exhibiting <2 mm radiopaque bone between the root apex.

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 and reduction in pocket depth measured in millimeter.

Radiographic Success

时间窗: Baseline to one year

Absence of periapical alterations (radiolucency at furcal or periapical region).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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