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Effect of Probiotic Lozenges on Halitosis in Patients With Chronic Periodontitis

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02789436
Enrollment
30
Registered
2016-06-03
Start date
2016-06-30
Completion date
Unknown
Last updated
2016-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Halitosis

Keywords

halitosis, chronic periodontitis, probiotic

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.

Interventions

DRUGL. reuteri Prodentis® lozenges

Twice daily, for 28 days

Twice daily, for 28 days

Sponsors

BioGaia AB
CollaboratorINDUSTRY
University of Zagreb
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in VSC concentration in mouth air28 daysAssessed with halimeter

Secondary

MeasureTime frameDescription
Changes in halitosis associated quality of life28 daysAssessed with Halitosis Associated Life-quality Test (Kizhnev et al., 2011)
Change from Baseline in Plaque Accumulation (PCR)28 daysAssessed with PCR index (Plaque Control Record - O'Leary et al., 1972)
Change from Baseline in Bleeding on Probing (BOP)28 daysAssessed with BOP index (Bleeding on Probing, Ainamo and Bay, 1975)

Countries

Croatia

Contacts

Primary ContactLarisa Musić, DMD
lmusic@sfzg.hr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026