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临床试验/NCT02627326
NCT02627326已完成2 期

Evaluation of Effectiveness of Chlorhexidine Intracanal Medicament on Periodontal Healing in Concomitant Endodontic and Periodontal Disease With Communication : A Randomized Controlled Clinical Trial

Postgraduate Institute of Dental Sciences Rohtak0 个研究点目标入组 60 人开始时间: 2014年5月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
60
主要终点
probing pocket depth

研究概览

简要总结

The aim of this prospective randomized controlled clinical trial is to evaluate the effectiveness of chlorhexidine intracanal medicament along with periodontal treatment in concomitant endodontic periodontal lesions with communication in terms of periodontal healing. Forty-seven patients were randomly divided into: group 1: conventional endodontic treatment with open flap debridement (OFD after 3 month of endodontic treatment) were performed, in group 2: endodontic treatment with 2% chlorhexidine gel (CHX) as an intracanal medicament placed in root canals and after 3 month OFD were performed. Primary outcome variables included probing pocket depth, clinical attachment level and bleeding on probing.

详细描述

INTRODUCTION:

Treatment decision-making and prognosis of endodontic-periodontal lesion is primarily dependent on the diagnosis of the specific endodontic or periodontal disease. Although the treatment of endodontic and periodontal lesions arouse a lot of confusions and speculations. Wherein, endodontic-periodontal combined lesion is a clinical dilemma because making a differential diagnosis and deciding a prognosis are difficult. Also, the success of such lesions depends on the elimination of both of these disease processes as the endodontic therapy results in healing of the endodontic component of involvement while the prognosis of tooth would finally depend on the healing of the periodontal structures.

Interventional studies also reported negative influence on the periodontal healing in presence of infected root canal system, after providing periodontal treatment. However, in addition to this, 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. 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.

The elimination of microorganisms from infected root canal is a complicated task involving the use of various instrumentation techniques, irrigation regimens and intracanal medicaments. Gomes et al observed that 2% chlorhexidine (CHX) showed maximum zone of inhibition against porphyromonas gingivalis, enterococcus faecalis, actinomyces viscosus and candida albicans followed by a combination of calcium hydroxide and CHX, and least with calcium hydroxide alone. A clinical study carried out by zamany et al showed that 2% CHX solution used as a final irrigant, significantly decreased bacterial loads in root canal. Additional advantages of chlorhexidine are its retentive character in root canal dentin and its relatively low toxicity and its effect on periodontal healing has been well known. Based on these observations, it may be hypothesized that intracanal medicament may act as a controlled released drug which could be used as an adjunct to periodontal surgical therapy .

Thus the present study was conducted to evaluate the effectiveness of chlorhexidine intracanal medicament along with periodontal surgical therapy on periodontal healing in concomitant endodontic and periodontic disease with communication.

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, Investigator)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of age between 18-55 years with generalized chronic periodontitis and having at least one tooth with concomitant endodontic periodontal lesion with communication including following features:
  • a clinical and radiographic diagnosis of concomitant endodontic periodontal lesion
  • Wide base pocket, deep probing pocket depth
  • Non vital tooth with periapical radiolucency
  • Radiographic alveolar bone (marginal bone) destruction with apical communication Criteria for generalized chronic periodontitis [≥30% sites involved with clinical attachment loss (CAL) 1-2mm (mild) or 3-4mm (moderate) or ≥5mm (severe)]40 Patient should have more than 20 teeth

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 or bisphosphonates.
  • Patients allergic to medication (local anaesthetic, antibiotics, NSAID).
  • Patients with acute symptoms.
  • Pregnant or lactating females.
  • Smokers (current and past) and tobacco chewers.
  • Grade 3 mobile teeth.
  • Unrestorable tooth.
  • Root resorption.
  • Fractured/perforated roots.
  • Developing permanent tooth.
  • Abutments.
  • Previously root canal filled.
  • Patients with aggressive periodontitis
  • History of periodontal treatment within 6 months prior to study.

结局指标

主要结局

probing pocket depth

时间窗: 9 months

clinical attachment level

时间窗: 9 months

bleeding on probing

时间窗: 9 months

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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