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临床试验/NCT03711942
NCT03711942已完成不适用

Comparison of Healing of Apical Periodontitis in Periodontally Diseased and Healthy Patients.

Postgraduate Institute of Dental Sciences Rohtak0 个研究点目标入组 90 人开始时间: 2016年10月15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
90
主要终点
Healing of apical periodontitis

研究概览

简要总结

Periodontal health may jeopardize the success of endodontic treatment.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.This study compared the apical healing in healthy and periodontally compromised teeth and evaluated the effect of intra orifice barrier and base in the healing of apical periodontitis.

详细描述

Endodontic treatment comprises bio-mechanical preparation of root canal system, chemical debridement and obturation with inert material. Various prognostic factors like adequacy of root filling, pre-operative size of periapical lesion on radiograph, type and location of teeth, periodontal status of the teeth and coronal restoration may play role in the success of endodontic treatment.

In the presence of defective coronal seal percolation of saliva and microbes may take place causing treatment failure. This assumption has acquired support mainly from various in-vitro studies which has demonstrated penetration of dye /microbe / radioactive tracer along root filling. Marshall and Massler in an in-vitro study using radioisotopes were first to highlight effect of coronal leakage and later Swanson and Madison in a study involving 70 extracted single rooted human teeth showed complete dye penetration throughout obturation material and along the canal walls. Since then there has been a renewed interest in the endodontic community in exploring relation of coronal seal with prognosis of endodontic treatment.

In a retrospective study Ray and Trope concluded that coronal restoration has greater impact on success of endodontic therapy rather than quality of root filling. However, various other epidemiological studies failed to replicate this result. A recent meta-analysis stated that problem of coronal leakage may not be of that clinical significance as demonstrated in various in-vitro studies, though importance of good coronal restoration and good root filling in the success of endodontic treatment can't be denied.

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 may also contribute in worsening of periodontal health by promoting marginal bone loss and pocket formation. Similarity between microflora of periodontium and root canal has led to a view that the communication between the two exists, and can potentially affect status of one another. The observations on this issue have been conflicting in nature with some authors reporting pulpal necrosis due to periodontal disease, and others reporting normal teeth regardless of severity of periodontal disease (Zehnder). Stassen et al. in a retrospective study observed more signs of apical periodontitis in teeth with reduced marginal support. They also reported significant influence of coronal extent of obturation on outcome of endodontic treatment in periodontally compromised patients. Significantly less incidence of apical periodontitis was seen where gutta percha was apical to marginal bone as compared to gutta percha being coronal to marginal bone. It is evident that the interrelationship between root canal and periodontium is complicated, and still not fully understood on account of lack of studies exploring the topic So far no prospective clinical trial has investigated the effect of periodontal status on healing of apical periodontitis. Also in absence of a clinical study substantial amount of doubt still persists whether intraorifice barrier can emerge as an effective mean to prevent microleakage in furcation and root canals of a multirooted tooth which because of its anatomical aberrations poses stiff challenge for clinicians. Therefore aim of this study was to determine effect of the periodontal status on periapical healing and to determine effect of intracanal glass ionomer restoration as intraorifice barrier on treatment outcome of apical periodontitis.

Clinical procedure:

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 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Permanent mandibular molar with 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 (minimum size ≥ 2 mm ~ 2 mm),
  • Probing Depth of not more than 5mm.

排除标准

  • Patient with diabetes,
  • History of antibiotic intake in past 1 month,
  • Presence of any immunocompromised conditions,
  • Pregnant women, and
  • Root filled and unrestorable teeth

研究组 & 干预措施

Periodontally diseased Base

Active Comparator

2mm thick Base of GIC was applied under composite restoration

干预措施: Base (Procedure)

Periodontally Healthy IOB

Active Comparator

Intra orifice barrier (IOB) was placed in periodontally healthy molar.

干预措施: Intra orifice barrier (Procedure)

Periodontally healthy control

Experimental

coronal access was restored with composite resin without any base.

干预措施: Control (Procedure)

Periodontally diseased IOB

Active Comparator

Intra orifice barrier (IOB) was placed in periodontally healthy molar

干预措施: Intra orifice barrier (Procedure)

Periodontally diseased control

Active Comparator

coronal access was restored with composite resin without any base

干预措施: Control (Procedure)

Periodontally Healthy Base

Experimental

2mm thick base was applied in periodontally health teeth.

干预措施: Base (Procedure)

结局指标

主要结局

Healing of apical periodontitis

时间窗: Baseline to one year

Clinical success as depicted by absence of signs and symptoms, and radiographic success demonstrated by absence of periapical alterations (radiolucency at furcal or periapical region).

次要结局

  • Healing of marginal periodontitis(Baseline to one year)

研究者

申办方类型
Other
责任方
Sponsor

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