Effect of Probiotic Lozenges on Halitosis in Patients With Chronic Periodontitis
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|ClinicalTrials.gov Identifier: NCT02789436|
Recruitment Status : Unknown
Verified May 2016 by Larisa Musić, University of Zagreb.
Recruitment status was: Not yet recruiting
First Posted : June 3, 2016
Last Update Posted : June 3, 2016
|Condition or disease||Intervention/treatment||Phase|
|Halitosis||Drug: L. reuteri Prodentis® lozenges Other: Placebo lozenges||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effect of Probiotic Lactobacillus Reuteri-containing Lozenges (Prodentis) on Halitosis in Patients With Chronic Periodontitis|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||September 2016|
Experimental: L. reuteri Prodentis® lozenges
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.
Drug: L. reuteri Prodentis® lozenges
Twice daily, for 28 days
Placebo Comparator: Placebo lozenges
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.
Other: Placebo lozenges
Twice daily, for 28 days
- Change in VSC concentration in mouth air [ Time Frame: 28 days ]Assessed with halimeter
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02789436
|Contact: Larisa Musić, DMDfirstname.lastname@example.org|
|University of Zagreb, School of Dental Medicine Zagreb||Not yet recruiting|
|Zagreb, Croatia, 10000|
|Contact: Larisa Musić, DMD email@example.com|
|Study Director:||Darije Plančak, Professor||University of Zagreb, School of Dental Medicine|