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Effect of Probiotic Lozenges on Halitosis in Patients With Chronic Periodontitis

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ClinicalTrials.gov Identifier: NCT02789436
Recruitment Status : Unknown
Verified May 2016 by Larisa Musić, University of Zagreb.
Recruitment status was:  Not yet recruiting
First Posted : June 3, 2016
Last Update Posted : June 3, 2016
Sponsor:
Collaborator:
BioGaia AB
Information provided by (Responsible Party):
Larisa Musić, University of Zagreb

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.

Condition or disease Intervention/treatment Phase
Halitosis Drug: L. reuteri Prodentis® lozenges Other: Placebo lozenges Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Effect of Probiotic Lactobacillus Reuteri-containing Lozenges (Prodentis) on Halitosis in Patients With Chronic Periodontitis
Study Start Date : June 2016
Estimated Primary Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bad Breath

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




Primary Outcome Measures :
  1. Change in VSC concentration in mouth air [ Time Frame: 28 days ]
    Assessed with halimeter


Secondary Outcome Measures :
  1. Changes in halitosis associated quality of life [ Time Frame: 28 days ]
    Assessed with Halitosis Associated Life-quality Test (Kizhnev et al., 2011)

  2. Change from Baseline in Plaque Accumulation (PCR) [ Time Frame: 28 days ]
    Assessed with PCR index (Plaque Control Record - O'Leary et al., 1972)

  3. Change from Baseline in Bleeding on Probing (BOP) [ Time Frame: 28 days ]
    Assessed with BOP index (Bleeding on Probing, Ainamo and Bay, 1975)



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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02789436


Contacts
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Contact: Larisa Musić, DMD lmusic@sfzg.hr

Locations
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Croatia
University of Zagreb, School of Dental Medicine Zagreb Not yet recruiting
Zagreb, Croatia, 10000
Contact: Larisa Musić, DMD       lmusic@sfzg.hr   
Sponsors and Collaborators
University of Zagreb
BioGaia AB
Investigators
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Study Director: Darije Plančak, Professor University of Zagreb, School of Dental Medicine

Publications:
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Responsible Party: Larisa Musić, Doctor of Dental Medicine, University of Zagreb
ClinicalTrials.gov Identifier: NCT02789436     History of Changes
Other Study ID Numbers: 05-PA-26-10/15
First Posted: June 3, 2016    Key Record Dates
Last Update Posted: June 3, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Larisa Musić, University of Zagreb:
halitosis
chronic periodontitis
probiotic
Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Halitosis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Signs and Symptoms, Digestive
Signs and Symptoms