Clinical trial NCT02789436: Effect of Probiotic Lozenges on Halitosis in Patients With Chronic Periodontitis
Official title: Effect of Probiotic Lactobacillus Reuteri-containing Lozenges (Prodentis) on Halitosis in Patients With Chronic Periodontitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Halitosis
Keywords: halitosis
chronic periodontitis
probiotic
Lead sponsor: University of Zagreb
Sponsor class: OTHER
Collaborators: name: BioGaia AB
First posted: 2016-06-03
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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 description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in VSC concentration in mouth air
timeFrame: 28 days
Secondary outcomes:
measure: Changes in halitosis associated quality of life
timeFrame: 28 days
measure: Change from Baseline in Plaque Accumulation (PCR)
timeFrame: 28 days
measure: Change from Baseline in Bleeding on Probing (BOP)
timeFrame: 28 days
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University of Zagreb, School of Dental Medicine Zagreb
Study officials:
affiliation: University of Zagreb, School of Dental Medicine
name: Darije Plančak, Professor
role: STUDY_DIRECTOR
References:
citation: Loesche WJ, Kazor C. Microbiology and treatment of halitosis. Periodontol 2000. 2002;28:256-79. doi: 10.1034/j.1600-0757.2002.280111.x.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Haukioja A. Probiotics and oral health. Eur J Dent. 2010 Jul;4(3):348-55.