Effect of Probiotic Lozenges on Halitosis in Patients With Chronic Periodontitis

May 29, 2016 updated by: Larisa Musić, University of Zagreb

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Zagreb, Croatia, 10000
        • University of Zagreb, School of Dental Medicine Zagreb

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: L. reuteri Prodentis® lozenges

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
Twice daily, for 28 days
Placebo Comparator: Placebo lozenges

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
Twice daily, for 28 days

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in halitosis associated quality of life
Time Frame: 28 days
Assessed with Halitosis Associated Life-quality Test (Kizhnev et al., 2011)
28 days
Change from Baseline in Plaque Accumulation (PCR)
Time Frame: 28 days
Assessed with PCR index (Plaque Control Record - O'Leary et al., 1972)
28 days
Change from Baseline in Bleeding on Probing (BOP)
Time Frame: 28 days
Assessed with BOP index (Bleeding on Probing, Ainamo and Bay, 1975)
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zagreb

Collaborators

BioGaia AB

Investigators

  • Study Director: Darije Plančak, Professor, University of Zagreb School of Dental Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

April 4, 2016

First Submitted That Met QC Criteria

May 29, 2016

First Posted (Estimate)

June 3, 2016

Study Record Updates

Last Update Posted (Estimate)

June 3, 2016

Last Update Submitted That Met QC Criteria

May 29, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-PA-26-10/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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