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| Name | Class |
|---|---|
| BioGaia AB | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L. reuteri Prodentis® lozenges | Drug | Twice daily, for 28 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in VSC concentration in mouth air | Assessed with halimeter | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in halitosis associated quality of life | Assessed with Halitosis Associated Life-quality Test (Kizhnev et al., 2011) | 28 days |
| Change from Baseline in Plaque Accumulation (PCR) | Assessed with PCR index (Plaque Control Record - O'Leary et al., 1972) |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Larisa Musić, DMD | Contact | lmusic@sfzg.hr |
| Name | Affiliation | Role |
|---|---|---|
| Darije Plančak, Professor | University of Zagreb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Zagreb, School of Dental Medicine Zagreb | Zagreb | 10000 | Croatia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12013345 | Background | Loesche WJ, Kazor C. Microbiology and treatment of halitosis. Periodontol 2000. 2002;28:256-79. doi: 10.1034/j.1600-0757.2002.280111.x. | |
| 9250193 | Background | Delanghe G, Ghyselen J, van Steenberghe D, Feenstra L. Multidisciplinary breath-odour clinic. Lancet. 1997 Jul 19;350(9072):187. doi: 10.1016/S0140-6736(05)62354-9. No abstract available. |
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| ID | Term |
|---|---|
| D006209 | Halitosis |
| D055113 | Chronic Periodontitis |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010518 | Periodontitis |
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| Placebo lozenges |
| Other |
Twice daily, for 28 days |
|
| 28 days |
| Change from Baseline in Bleeding on Probing (BOP) | Assessed with BOP index (Bleeding on Probing, Ainamo and Bay, 1975) | 28 days |
| 2639302 | Background | Persson S, Claesson R, Carlsson J. The capacity of subgingival microbiotas to produce volatile sulfur compounds in human serum. Oral Microbiol Immunol. 1989 Sep;4(3):169-72. doi: 10.1111/j.1399-302x.1989.tb00246.x. |
| 2082242 | Background | Persson S, Edlund MB, Claesson R, Carlsson J. The formation of hydrogen sulfide and methyl mercaptan by oral bacteria. Oral Microbiol Immunol. 1990 Aug;5(4):195-201. doi: 10.1111/j.1399-302x.1990.tb00645.x. |
| 8046106 | Background | Goldberg S, Kozlovsky A, Gordon D, Gelernter I, Sintov A, Rosenberg M. Cadaverine as a putative component of oral malodor. J Dent Res. 1994 Jun;73(6):1168-72. doi: 10.1177/00220345940730060701. |
| 18181730 | Background | Walker WA. Mechanisms of action of probiotics. Clin Infect Dis. 2008 Feb 1;46 Suppl 2:S87-91; discussion S144-51. doi: 10.1086/523335. |
| 20613927 | Background | Haukioja A. Probiotics and oral health. Eur J Dent. 2010 Jul;4(3):348-55. |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |