跳至主要内容
临床试验/NCT01234948
NCT01234948已完成不适用

Oral Malodour and Periodontal Disease-related Parameters. Clinical and Real-time PCR Findings

Aristotle University Of Thessaloniki1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2008年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
78
试验地点
1
主要终点
Halitosis presence

研究概览

简要总结

The primary aim of the current study was to determine the association between halitosis detection (presence or absence) and periodontal status in non-smoking subjects, and also assess whether halitosis recordings were related to periodontal clinical parameters, tongue coating and quantities of two putative periodontal pathogens on the posterior region of the tongue determined by real-time PCR. Secondary, halitosis recordings were compared among subjects with chronic periodontitis, chronic generalized gingivitis and periodontal health.

详细描述

A debate in the literature exists as to whether periodontitis is linked with oral malodour and this study attempts to understand the way in which periodontal disease is associated with oral malodour-related parameters.

Clinical protocol:

Seventy-eight systemically healthy non-smokers were screened for oral halitosis in the Department of Periodontology, Aristotle University of Thessaloniki, Greece. These were non-halitosis complaining subjects. After initial screening for suitability and obtaining a signed informed consent approved by the Ethics Committee of the Dental School, Aristotle University of Thessaloniki, a full-mouth periodontal charting was recorded including plaque index (PI), clinical probing depth (CPD), clinical attachment levels (CAL) and bleeding on probing (BOP) at six sites per tooth using a manual periodontal probe (Hu-Friedy XP-23/QW). The subjects that fulfilled the clinical inclusion criteria were classified as chronic periodontitis (N=28), chronic generalised gingivitis (N=23) or healthy individuals (27) and were further clinically and microbiologically monitored.

Assessment of tongue coating:

The Winkel Tongue Coating Index (Winkel et al., 2003) was visually determined by dividing the dorsum of the tongue into sextants. A score between zero and two was given to each sextant according to the amount of deposits and these scores were added giving a total ranging from zero to 12.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • The clinical inclusion criteria were as follows:
  • (I) Chronic periodontitis patients had at least one site per quadrant with clinical probing depth (CPD) > 5mm and radiographic evidence of bone loss; (II) Generalised chronic gingivitis patients presented with bleeding on probing (BOP) at > 30% of sites, CPDs < 4mm and no evidence of bone loss; (III) Healthy subjects had < 10% sites with BOP and no sites with CPD > 3mm.

排除标准

  • Less than 20 teeth, smoking (during the previous year), presence of any systemic disease (e.g. diabetes mellitus, gastrointestinal disorders, etc.) including ENT complications, prescribed medication that can cause xerostomia based on the Greek National Formulary of drugs, full and/or partial dentures, heavily restored dentition, large carious cavities that can trap food remnants, pathology of the oral tissues (pericoronitis, dental / periodontal abscess, etc), antibiotic therapy within three months of recruitment, periodontal treatment within the last year, pregnancy or lactation.

结局指标

主要结局

Halitosis presence

时间窗: At a single time point

Subjects were designated as halitosis positive (+) when either the organoleptic score of the whole mouth air was two or more, and/or the readings of the Halimeter® exceeded 140 p.p.b.

次要结局

  • Tongue coating(At a single time point)
  • Putative periodontal pathogens(At a single time point)
  • Periodontal clinical indices(At a single time point)

研究者

申办方类型
Other

研究点 (1)

Loading locations...

相似试验