Effect of Probiotic Lozenges on Halitosis in Patients With Chronic Periodontitis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Halitosis

Intervention / Treatment
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* Drug: L. reuteri Prodentis® lozenges
* Other: Placebo lozenges


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: L. reuteri Prodentis® lozenges<br>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. | Drug: L. reuteri Prodentis® lozenges<br>* Twice daily, for 28 days<br>|
| Placebo Comparator: Placebo lozenges<br>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. | Other: Placebo lozenges<br>* Twice daily, for 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in VSC concentration in mouth air | Assessed with halimeter | 28 days | 

Secondary Outcome Measures

| Outcome Measure | 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) | 28 days | 
| Change from Baseline in Bleeding on Probing (BOP) | Assessed with BOP index (Bleeding on Probing, Ainamo and Bay, 1975) | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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halitosis, chronic periodontitis, probiotic