Effect of Probiotic Lozenges on Halitosis in Patients With Chronic Periodontitis

Halitosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02789436
• Other study ID #: 05-PA-26-10/15
• Status: Not yet recruiting
• Phase: Phase 4
• First received: April 4, 2016
• Last updated: May 29, 2016
• Start date: June 2016

Study information

• Verified date: May 2016
• Source: University of Zagreb
• Contact: Larisa Music, DMD
• Email: lmusic[@]sfzg.hr
• Is FDA regulated: No
• Health authority: Croatia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Chronic Periodontitis
• Halitosis
• Periodontitis

Intervention

Drug:
• L. reuteri Prodentis® lozenges
Twice daily, for 28 days

Other:
• Placebo lozenges
Twice daily, for 28 days

Locations

Country	Name	City	State
Croatia	University of Zagreb, School of Dental Medicine Zagreb	Zagreb

Sponsors (2)

Lead Sponsor	Collaborator
University of Zagreb	BioGaia AB

Country where clinical trial is conducted

Croatia, 

References & Publications (7)

Delanghe G, Ghyselen J, van Steenberghe D, Feenstra L. Multidisciplinary breath-odour clinic. Lancet. 1997 Jul 19;350(9072):187. — View Citation

Goldberg S, Kozlovsky A, Gordon D, Gelernter I, Sintov A, Rosenberg M. Cadaverine as a putative component of oral malodor. J Dent Res. 1994 Jun;73(6):1168-72. — View Citation

Haukioja A. Probiotics and oral health. Eur J Dent. 2010 Jul;4(3):348-55. — View Citation

Loesche WJ, Kazor C. Microbiology and treatment of halitosis. Periodontol 2000. 2002;28:256-79. Review. — View Citation

Persson S, Claesson R, Carlsson J. The capacity of subgingival microbiotas to produce volatile sulfur compounds in human serum. Oral Microbiol Immunol. 1989 Sep;4(3):169-72. — View Citation

Persson S, Edlund MB, Claesson R, Carlsson J. The formation of hydrogen sulfide and methyl mercaptan by oral bacteria. Oral Microbiol Immunol. 1990 Aug;5(4):195-201. — View Citation

Walker WA. Mechanisms of action of probiotics. Clin Infect Dis. 2008 Feb 1;46 Suppl 2:S87-91; discussion S144-51. doi: 10.1086/523335. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in VSC concentration in mouth air	Assessed with halimeter	28 days	No
Secondary	Changes in halitosis associated quality of life	Assessed with Halitosis Associated Life-quality Test (Kizhnev et al., 2011)	28 days	No
Secondary	Change from Baseline in Plaque Accumulation (PCR)	Assessed with PCR index (Plaque Control Record - O'Leary et al., 1972)	28 days	No
Secondary	Change from Baseline in Bleeding on Probing (BOP)	Assessed with BOP index (Bleeding on Probing, Ainamo and Bay, 1975)	28 days	No