Suspended

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

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What is being tested

L. reuteri Prodentis® lozenges

+ Placebo lozenges

DrugOther
Who is being recruted

Chronic Disease+9

+ Halitosis

+ Stomatognathic Diseases

Over 30 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Placebo-ControlledPhase 4
Interventional
Study Start: June 2016
See protocol details

Summary

Principal SponsorUniversity of Zagreb
Study ContactLarisa Musić, DMD
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2016

Actual date on which the first participant was enrolled.

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 TitleEffect of Probiotic Lactobacillus Reuteri-containing Lozenges (Prodentis) on Halitosis in Patients With Chronic Periodontitis
NCT02789436
Principal SponsorUniversity of Zagreb
Study ContactLarisa Musić, DMD
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 30 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Chronic DiseaseHalitosisStomatognathic DiseasesMouth DiseasesPathologic ProcessesPeriodontal DiseasesPeriodontitisSigns and SymptomsSigns and Symptoms, DigestivePathological Conditions, Signs and SymptomsDisease AttributesChronic Periodontitis

Criteria

6 inclusion criteria required to participate
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

Show More Criteria

9 exclusion criteria prevent from participating
Aggressive periodontitis

Antibiotics administered up to 3 months prior to this study

Pregnancy and breastfeeding

Immunosuppressive therapy

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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.

Group II

Placebo
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Zagreb, School of Dental Medicine Zagreb

Zagreb, CroatiaOpen University of Zagreb, School of Dental Medicine Zagreb in Google Maps
SuspendedOne Study Center