跳至主要内容
临床试验/NCT01318928
NCT01318928Unknown4 期

The Treatment of Periodontal Diseases. A Randomized, Blinded, Five Years Follow-up, Four-arm, Placebo Controlled Clinical Intervention Trial

University of Oslo1 个研究点 分布在 1 个国家目标入组 184 人开始时间: 2008年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
184
试验地点
1
主要终点
Periodontal Attachment Level

研究概览

简要总结

The purpose of this study is to examine if the correct use of antibiotics, as well as the application of one-day-treatment, in the therapy of periodontal diseases. The population of treated patients (184) are divided in 4 groups; Group 1: Metronidazole + mechanical treatment in one day, Group 2: Placebo + mechanical treatment in one day Group 3: Metronidazole + mechanical treatment on day 1 and 21 Group 4: Placebo + mechanical treatment on day 1 and 21 End points, BOP, Plaque, PPD, CAL, RAL, Microbiology will be recorded on all sites at 3 months, 1 -, 3 -, and 5 years post-treatment

详细描述

This is a clinical research project in the odontologic special field; periodontology. Periodontitis affects > 50% of all persons over 40 years-of-age, whereof 5 - 10% is prone to loose one or more teeth due to the disease. In Norway, less than 40% of the periodontal treatment costs are carried (refunded) by the public. The proportion of personal expenses vs. public spending depends on how serious the periodontitis is diagnosed, and on the individual treatment provided. In addition comes expenses connected to the restoration of the dentition when teeth are lost as a consequence of the disease, and therefore the social, personal and economical consequence of serious tooth loss can be devastating to the patient.

Background and established knowledge Periodontal disease is a family of bacterial infections characterized by the destruction of periodontal supporting tissues. The bacterial flora at the diseased sites is complex, counting > 500 different species in the subgingival dental plaque. Three main hypotheses exist in explaining the infectious nature of periodontal disease; the non-specific infection hypothesis (Theilade 1986), the specific infection hypothesis (Slots and Rams 1991, Loesche 1992) and the ecological plaque hypothesis (Marsh 1994).

Dental biofilm is an important factor in periodontal health and disease (review: Socransky and Haffajee 2002), and is a more correct wording for the term plaque. Most biofilms are biologically compatible with health, as their formation is influenced by the selective pressure of the host organism. It is also of great practical interest that bacteria organized in biofilms are highly resistant to antibiotics as compared to those in a planktonic state. In the development of dental biofilms, the host receives bacteria with different properties from close relatives and others, depending on the living conditions (Tinoco et al 1998). If there are pathogenic bacteria among these, the possibility for developing periodontitis increases (Preus et al 1995). This indicates that periodontal treatment must be aimed at breaking the ecology of the pathogenic biofilm, and then increase the organisms' ability to perform its selective pressure, following treatment, in the making of a new biofilm low of, or free from pathogenic microorganisms.

Traditional Treatment strategies have so far aimed at preventing or retarding the progression of the disease through mechanical, non-specific treatment, and we have succeeded to a certain extent.

Scaling and root planing (SRP) is the standard treatment, aiming to mechanically reduce the number of bacteria present on the affected root surfaces. Representing a non-specific form of treatment to a non-specific infection, it has proven effective in most cases and short follow ups(Hill et al 1981, Pihlstrøm et al 1983, Lindhe et al 1984, Becker et al 1990, Kaldahl et al 1993). However, recurrence rate is fairly high, suggesting that these diseases are life-long traits. Also, a small - still significant - group of patients shows remaining inflammation and continuous destruction of periodontal support despite adequate oral hygiene and proper mechanical treatment (Lang et al 1986, Greenstein & Caton 1990, Walker et al 1993, Bragd et al 1987, Renvert et al 1990, Haffajee et al 1991, Grossi et al 1994, Slots and Rams 1991, Socransky and Haffajee 1992).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
35 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Females and males with advanced periodontal disease referred between November 2007 and January
  • No diseases known to be associated with periodontal diseases, i.e. diabetes mellitus, rheumatoid arthritis, pregnancies.
  • No continuous medication known to affect the severity or progression of periodontal diseases.
  • No previous systematic periodontal treatment.
  • More than 5 pockets 5mm < PPD < 9 mm after a 3 month hygiene phase - i.e. before inclusion into study.
  • Oral hygiene; < 5% of surfaces with plaque at inclusion time.
  • Signing an informed consent.
  • Exclusion criteria:
  • diseases known to be associated with periodontal diseases, i.e. diabetes mellitus, rheumatoid arthritis.
  • pregnancy
  • continuous medication known to affect the clinical expression of periodontal diseases
  • subgingival microbiological diagnosis which reveals bacteria with reduced/no sensitivity to metronidazole

排除标准

  • 未提供

研究组 & 干预措施

Periodontal intervention, sugar pill

Placebo Comparator

Group 1: metronidazole + mechanical treatment in one day, Group 2: Placebo + mechanical treatment in one day Group 3: metronidazole + mechanical treatment on day 1 and 21 Group 4: Placebo + mechanical treatment on day 1 and 21

干预措施: Metronidazol (Drug)

结局指标

主要结局

Periodontal Attachment Level

时间窗: 5 years post-treatment

Measurements on roentgenograms of bone level vs fixed point on teeth

次要结局

  • Microbiological diagnosis(5 year post-treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hans Ragnar Preus

professor, dr.odont

University of Oslo

研究点 (1)

Loading locations...

相似试验

The Treatment of Periodontal Diseases | 临床试验