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临床试验/NCT02630745
NCT02630745已完成不适用

Evaluation of the Effect of Immediate and Delayed Surgical Periodontal Therapy After Non-surgical Endodontic Treatment on Periodontal Healing in Concurrent Endodontic Periodontal Lesion With Communication-A Randomized Clinical Trial"

Postgraduate Institute of Dental Sciences Rohtak0 个研究点目标入组 40 人开始时间: 2015年6月最近更新:
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
40
主要终点
Relative Attachment Loss

研究概览

简要总结

The aim of the study is to conduct a prospective randomized clinical trial to evaluate the effect of immediate and delayed surgical periodontal therapy after non-surgical endodontic treatment on periodontal healing of the concurrent endodontic -periodontal lesion with communication.

详细描述

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-periodontic lesions without communication. This avoids several complications and provides a more favourable environment for periodontal repair. Treatment results of endodontic therapy should be evaluated in 2-3 months and only then periodontal treatment should be considered. But review articles states that teeth that have concurrent endodontic and periodontal diseases that communicate with each other will require comprehensive treatment with both endodontic and periodontal management. Ideally both infections should be removed before the root canal filling and any final restorations are provided. Completion of the root canal filling should be delayed until the periodontal prognosis has been reassessed and determined following initial, and often further, periodontal treatment. Though Infected root canal systems and periodontal pockets have similar microbiological flora, there are more microbes and more species of spirochetes in periodontal pockets than in infected root canal systems, and the microflora in infected root canals of teeth that have concurrent endodontic and periodontal diseases is more complex than in teeth with infection confined to the periapical region. So the outcome of endodontic treatment may be affected if the root canal filling is placed while there is still a periodontal infection present that communicates with the root canal system since cross-seeding through the apical or lateral foramina is possible. An In-vitro study on human extracted teeth states that despite thorough cleaning and disinfection of the root canal system during endodontic treatment, bacteria from the periodontal lesion may re-invade the root canal system since root canal fillings do not seal canals completely.

All the above findings are based on microbiological,histological,case-reports,retrospective and in-vitro studies.The timing of periodontal treatment in concurrent endodontic -periodontal lesions with communication still remains a issue of debate.No prospective human clinical trial(randomized) has been conducted till date to ascertain whether surgical periodontal treatment should be given immediately after completion of non-surgical endodontic treatment or 2-3 months after completion of non-surgical endodontic treatment.

Thus the aim of our study is to conduct a prospective randomized clinical trial to evaluate the effect of immediate and delayed surgical periodontal therapy after non-surgical endodontic treatment for the management of concurrent endodontic -periodontal lesion with communication.

MATERIAL AND METHOD This randomized clinical trial will be conducted in Department of Periodontics and Oral Implantology in collaboration with Department of Conservative Dentistry and Endodontics, Post Graduate Institute of Dental Sciences, Rohtak.

STUDY POPULATION Patients were recruited from regular out patient department of the department of periodontics and oral implantology,department of conservative dentistry and endodontics and department of oral medicine, diagnosis and radiology. The study will be conducted as follows:-

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 (Care Provider, Investigator)

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

  • Patients of age 18 years and above with a clinical and radiographic diagnosis of combined endodontic periodontal lesion and having generalized chronic periodontitis with at least one non vital tooth having apical radiolucency with communication.
  • Wide base pocket, deep pocket depth
  • Non vital tooth (confirmed by heat test, cold test and electronic pulp test)
  • Radiographic periapical alveolar bone destruction with 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.

研究组 & 干预措施

Immediate periodontal surgery (Group 1)

Active Comparator

periodontal surgical procedure in the form of open flap debridement will be performed immediately( in which after debridement mucoperiosteal flaps will be repositioned and secured by using 3-0 non-absorbable black silk surgical suture) after obturation of the root canal system( using calcium hydroxide intracanal medicament placed with the help of 27 gauge endodontic syringe for 10 days and access cavity will be sealed with suitable sealer).

干预措施: Immediate periodontal surgery (Procedure)

Delayed periodontal surgery (Group 2)

Active Comparator

periodontal surgical procedure in the form of open flap debridement( in which after debridement mucoperiosteal flaps will be repositioned and secured by using 3-0 non-absorbable black silk surgical suture) will be performed 3 months after obturation of the root canal system ( using calcium hydroxide intracanal medicament placed with the help of 27 gauge endodontic syringe for 10 days and access cavity will be sealed with suitable sealer).

干预措施: Delayed periodontal surgery (Procedure)

结局指标

主要结局

Relative Attachment Loss

时间窗: 6 months in group 1, 9 months in group 2

measurement done by periodontal probe with stents

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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