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临床试验/NCT03230344
NCT03230344Unknown不适用

Surgical Periodontal Intervention With Simultaneous Versus Delayed Endodontic Treatment in Concurrent Endodontic-Periodontal Lesion Without Communication - An Interventional Study

Postgraduate Institute of Dental Sciences Rohtak1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2016年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
36
试验地点
1
主要终点
periodontal parameter: CAL

研究概览

简要总结

The aim of this study is to evaluate the periodontal parameters in terms of periodontal healing by periodontal surgical therapy with simultaneous or delayed endodontic therapy in management of concurrent endodontic -periodontal lesion without communication

详细描述

INTRODUCTION

The term " Endodontic-Periodontal " lesion has been proposed to describe the destructive lesions resulting from inflammatory products found in varying degrees in both the periodontium and the pulpal tissues. The term concurrent endodontic periodontal lesion without communication applies to a tooth that has an infected root canal system with some form of apical periodontitis plus marginal periodontal disease with pocketing but the periapical and periodontal disease do not communicate with each other.

Although there are many factors, the primary cause of both diseases is the presence of bacterial infection with complex microbial flora. Based on microbiological studies many authors have reported the similarity between bacterial flora associated with endodontic and periodontal infections. Therefore periodontal pocket may be a source of bacteria for root canal system or vice versa and cross seeding of bacteria can occur in either direction through communication pathways. An untreated infection of one of these tissues can lead to signs or symptoms of disease within the other tissue.

Observations based upon review articles and case reports has suggested, if the root canal system is infected, endodontic treatment should be commenced prior to any periodontal therapy in order to remove the intra-canal infection before any cementum is removed in case of concurrent endodontic - periodontal lesions without communication. Treatment results of endodontic therapy should be evaluated in 2-3 months and only then periodontal treatment should be considered.

Concerns about the possibility that endodontically treated teeth might not respond to periodontal therapy are certainly not new. Histological examination of human teeth concluded that endodontic therapy had adversely affected periodontal healing. Teeth that had undergone endodontic therapy did not respond well to regenerative procedures as teeth that had not undergone such treatment. It has been advocated to perform periodontal therapy before endodontic obturation because of the concern that the leakage of endodontic sealer would hinder repair, regeneration or both. There is a negative impact of certain root canal filling materials on fibroblast attachment to the dentin surface of extracted third molars. Also endodontic therapy performed simultaneously with or soon after periodontal surgery adversely affected the formation of new bone, new cementum and new attachment. It was also found in a study that periapical pathology was not significantly correlated to mean pocket depth reduction after non surgical and surgical treatment of horizontal and vertical defects .

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

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 of age 18 years and above, systematically healthy with chronic periodontitis having at least one tooth involving endodontic periodontal lesion without apical communication with following radiographic and clinical features:
  • •Wide base pocket, deep pocket depth
  • •Non vital tooth (confirmed by heat test, cold test and electronic pulp test)
  • •Radiographic periapical alveolar bone destruction and marginal bone loss without apical communication .

排除标准

  • •Systemic illness known to affect the periodontium or outcome of periodontal therapy.
  • •Patient taking medications such as corticosteroids or calcium channel blockers, which are known to interfere periodontal wound healing or patient on long term NSAID therapy.
  • •Patients allergic to medication (local anaesthetic, antibiotics, NSAID).
  • •Pregnant or lactating mothers.
  • •Smokers and tobacco chewers.
  • •Grade 3 mobile teeth.
  • •Unrestorable tooth.
  • •Fractured/perforated roots.
  • •Developing permanent tooth.
  • •Previously root canal filled.
  • •History of recent periodontal treatment within 6 months prior to study.
  • •Teeth with established endodontic periodontal lesions exhibiting <2mm radioopaque bone between the root apex and the periodontal breakdown and with apical communication found during surgery.

研究组 & 干预措施

Group 1

Active Comparator

Periodontal treatment initiated with scaling and root planing along with root canal treatment and followed by open flap debridement after 6 weeks.(Open flap debridement simultaneously with root canal treatment )

干预措施: open flap debridement (Procedure)

Group 2

Experimental

Periodontal treatment initiated with scaling and root planing followed by open flap debridement after 6 weeks. Endodontic treatment will be initiated after 3 months of periodontal surgery.(open flap debridement and delayed root canal treatment )

干预措施: open flap debridement (Procedure)

结局指标

主要结局

periodontal parameter: CAL

时间窗: 7.5 months

Clinical attachment level

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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