Effect of Probiotic Lozenges on Halitosis in Patients With Chronic Periodontitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Probiotics on Chronic Periodontitis in Smoker and Non- Smokers

NCT02329353

Chronic Periodontitis

COMPLETED PHASE3

Effect of a Probiotic Water on Oral Health in Adults

NCT04473404

Oral Bacteria Halitosis

COMPLETED NA

Effect Of A Locally Delivered Probiotic Sacchraomyces Boulardii In The Management Of Chronic Periodontitis

NCT03516370

Chronic Periodontitis

COMPLETED PHASE1/PHASE2

Clinical Effects of Limosilactobacillus Reuteri Probiotics as an Adjunct to the Treatment of Periodontitis

NCT05734274

Chronic Periodontitis, Generalized

RECRUITING NA

Efficacy of Supplementation With Probiotics as Adjuvant to Mechanical Treatment in Chronic Periodontitis

NCT03554187

Probiotics, Periodontitis

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Halitosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

L. reuteri Prodentis® lozenges

Intervention Type DRUG

Twice daily, for 28 days

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.

Group Type PLACEBO_COMPARATOR

Placebo lozenges

Intervention Type OTHER

Twice daily, for 28 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

L. reuteri Prodentis® lozenges

Twice daily, for 28 days

Intervention Type DRUG

Placebo lozenges

Twice daily, for 28 days

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No