Effect of Probiotic Lozenges on Halitosis in Patients With Chronic Periodontitis

Phase 4

• Conditions: Halitosis
• Interventions: Drug: L. reuteri Prodentis® lozenges; Other: Placebo lozenges

• Registration Number: NCT02789436
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-04-04
• Status Verified: 2016-05
• Study First Submitted QC: 2016-05-29
• Last Update Submitted: 2016-05-29
• Study Start: 2016-06
• Study First Posted: 2016-06-03
• Last Update Posted: 2016-06-03
• Primary Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
L. reuteri Prodentis® lozenges	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.
Placebo lozenges	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.

Primary Outcome Measures

Name	Time	Method
Change in VSC concentration in mouth air	28 days	Assessed with halimeter

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Zagreb, School of Dental Medicine Zagreb; 🇭🇷 Zagreb, Croatia