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临床试验/EUCTR2006-001367-36-DE
EUCTR2006-001367-36-DE进行中(未招募)不适用

Benefit of adjunctive systemic postsurgical doxycycline in regenerative periodontal surgery - Effect of postsurgical systemic doxycycline after regenerative periodontal therapy. A randomized pla

Prof. Dr. Peter Eickholz0 个研究点目标入组 90 人开始时间: 2006年8月29日最近更新:
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试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
90

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • - adult patients (at least 18 years of age) with moderate to severe periodontal disease (chronic and aggressive periodontitis) to be recruited from the Department of Periodontology, Centre for Dental, Oral, and Maxillofacial Medicine, Hospital of the Johann Wolfgang Goethe-University Frankfurt/Main and from the Section of Periodontology, Department of Conservative Dentistry, Clinic for Oral, Dental, and Maxillofacial Diseases, University Hospital Heidelberg
  • - completed initial periodontal treatment consisting of oral hygiene instruction, scaling and root planing under local anesthesia according the concept of full-mouth disinfection and re evaluation of the tissue response and the patient's plaque control 3 months later. Sites with infrabony defects and persisting pockets (PD > 5 mm and bleeding on probing, BOP) that occur at re evaluation or supportive periodontal treatment (SPT) are subjected to surgical therapy.
  • - at least one radiographically detectable infrabony lesion (Goldmann & Cohen 1957, Weinberg & Estrow 2000)
  • - good physical health and with effective individual plaque control (Full-mouth-plaque score PCR - interproximal angular defects on single-rooted teeth or multi-rooted teeth without furcation involvement, radiographic infrabony component >/= 4 mm, vertical clinical attachment loss (CAL-V) > 6 mm and PPD >/= 6 mm
  • - Only women in childbearing age (< 45 years) who provide contraception from screening to U2- informed written consent
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • - known allergies to tetracyclines or any components of the active drug or placebo
  • - severe liver dysfunction
  • - local or systemic antibiotic treatment during the last 3 months before surgery
  • - ineffective individual plaque control (PCR > 30%)
  • - liver and/or kidney dysfunction
  • - medication with barbiturate, carbamazepin, diphenyhydantoine, sulfonyl-urea, methoxyfluran, ciclosporin A, theophylline, isotretionin
  • - chronic alcohol abuse
  • - anticoagulative therapy
  • - need for antibiotic endocarditis prophylaxis
  • - pregnancy
  • - lactation

研究者

发起方
Prof. Dr. Peter Eickholz

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