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临床试验/NCT02789436
NCT02789436Unknown4 期

Effect of Probiotic Lactobacillus Reuteri-containing Lozenges (Prodentis) on Halitosis in Patients With Chronic Periodontitis

University of Zagreb1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年6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
30
试验地点
1
主要终点
Change in VSC concentration in mouth air

研究概览

简要总结

The purpose of this study is to determine whether Lactobacillus reuteri-containing lozenges (Prodentis) are effective in treatment of halitosis in patients with chronic periodontitis.

详细描述

Bad breath (oral malodor, lat. halitosis) is amongst most common patients' complaints in the dental office. Ironically, available literature and research done on this topic thus far are relatively scarce. Oral malodor is most commonly caused by oral bacteria (87%), yet it can also be sourced from ear, nose and throat region and in a small percentage from distant parts of the body or is of unknown origin. Periodontal pathogens and other Gram(-) anaerobic microorganisms such as Porphyromonas gingivalis, Treponema denticola, Prevotella intermedia, Fusobacterium nucleatum, Enterobacter cloacae, Prevotella loescheii and Porphyromonas endodontalis are regarded as producers of malodorous gases. Namely, these bacterial species and periodontal pathogens particularly produce so called volatile sulfur compounds (VSC) which give mouth air its malodorness. Methylmercaptan, hydrogen sulfide and dimethyl sulfide are waste products of bacterial metabolism, specifically degradation of sulfur-, methionine- and cysteine-containing aminoacids. Offensive smells also stem from other compounds which do not contain sulfur, diamines and polyamines such as cadaverine, putrescine and skatole.

Probiotics are defined as living microorganisms which are considered to have beneficial health effect on their host when consumed in adequate amount. Regarding their advantageous role in periodontal disease, inhibition of specific periodontal pathogens and alteration of host immune response through multifactorial causes are thought to be their main working mechanisms. Reuterin and reutericyclin are two bacteriocins produced by Lactobacillus reuteri that inhibit growth of pathogenic bacteria, while bacterium also exhibits strong capacity of host tissue adherence and subsequent competition with pathogens.

Based on this data, research on efficacy of probiotic lozenges on halitosis in patients with chronic periodontitis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • Adult patients, above age of 30
  • Non-smokers or ex-smokers (not smoking in the past year)
  • Moderate to advanced untreated chronic periodontitis
  • Good compliance and following of oral hygiene instructions
  • Halitosis in active phase and patient's subjective complaint
  • Informed consent by the patient
  • Exclusion Criteria
  • Aggressive periodontitis
  • Antibiotics administered up to 3 months prior to this study
  • Pregnancy and breastfeeding
  • Immunosuppressive therapy
  • Oral neoplasms (including radiation or chemotherapy)
  • Diabetes mellitus
  • Acute oral inflammation or infection
  • Poor, unsatisfactory oral hygiene and lack of compliance
  • Use of dietary supplements containing probiotics within 2 weeks prior to study start

排除标准

  • 未提供

研究组 & 干预措施

L. reuteri Prodentis® lozenges

Experimental

15 subjects

Probiotic lozenges used in the trial is a non-commercial product provided by BioGaia AB, Lund, Sweden. The Probiotic lozenges consist of a minimum of 200 million live L. reuteri (L. reuteri DSM 17938 and L. reuteri ATCC PTA 5289 (L. reuteri Prodentis®). Probiotic lozenges are used twice daily for 28 days.

干预措施: L. reuteri Prodentis® lozenges (Drug)

Placebo lozenges

Placebo Comparator

15 subjects

Placebo lozenges used in the trial is non-commercial product provided by BioGaia AB, Lund, Sweden.Placebo lozenges are taken twice daily for 28 days.

干预措施: Placebo lozenges (Other)

结局指标

主要结局

Change in VSC concentration in mouth air

时间窗: 28 days

Assessed with halimeter

次要结局

  • Change from Baseline in Bleeding on Probing (BOP)(28 days)
  • Change from Baseline in Plaque Accumulation (PCR)(28 days)
  • Changes in halitosis associated quality of life(28 days)

研究者

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

Larisa Musić

Doctor of Dental Medicine

University of Zagreb

研究点 (1)

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