Clinical Trial: Effect of Probiotic Lozenges on Halitosis in Patients With Chronic Periodontitis

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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 loze
Sponsor: University of Zagreb

Current Primary Outcome: Change in VSC concentration in mouth air [ Time Frame: 28 days ]

Assessed with halimeter


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Changes in halitosis associated quality of life [ Time Frame: 28 days ]
    Assessed with Halitosis Associated Life-quality Test (Kizhnev et al., 2011)
  • Change from Baseline in Plaque Accumulation (PCR) [ Time Frame: 28 days ]
    Assessed with PCR index (Plaque Control Record - O'Leary et al., 1972)
  • Change from Baseline in Bleeding on Probing (BOP) [ Time Frame: 28 days ]
    Assessed with BOP index (Bleeding on Probing, Ainamo and Bay, 1975)


Original Secondary Outcome: Same as current

Information By: University of Zagreb

Dates:
Date Received: April 4, 2016
Date Started: June 2016
Date Completion:
Last Updated: May 29, 2016
Last Verified: May 2016