NCT02789436

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Last Updated

June 3, 2016

Status Verified

May 1, 2016

Enrollment Period

3 months

First QC Date

April 4, 2016

Last Update Submit

May 29, 2016

Conditions

Halitosis

Keywords

halitosischronic periodontitisprobiotic

Outcome Measures

Primary Outcomes (1)

  • Change in VSC concentration in mouth air

    Assessed with halimeter

    28 days

Secondary Outcomes (3)

  • Changes in halitosis associated quality of life

    28 days

  • Change from Baseline in Plaque Accumulation (PCR)

    28 days

  • Change from Baseline in Bleeding on Probing (BOP)

    28 days

Study Arms (2)

L. reuteri Prodentis® lozenges

EXPERIMENTAL

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

Placebo lozenges

PLACEBO COMPARATOR

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

Interventions

L. reuteri Prodentis® lozengesDRUG

Twice daily, for 28 days

L. reuteri Prodentis® lozenges
Placebo lozengesOTHER

Twice daily, for 28 days

Placebo lozenges

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Zagreb, School of Dental Medicine Zagreb

Zagreb, 10000, Croatia

Location

Related Publications (7)

  • Loesche WJ, Kazor C. Microbiology and treatment of halitosis. Periodontol 2000. 2002;28:256-79. doi: 10.1034/j.1600-0757.2002.280111.x.

    PMID: 12013345BACKGROUND

  • Delanghe G, Ghyselen J, van Steenberghe D, Feenstra L. Multidisciplinary breath-odour clinic. Lancet. 1997 Jul 19;350(9072):187. doi: 10.1016/S0140-6736(05)62354-9. No abstract available.

    PMID: 9250193BACKGROUND

  • 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. doi: 10.1111/j.1399-302x.1989.tb00246.x.

    PMID: 2639302BACKGROUND

  • 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. doi: 10.1111/j.1399-302x.1990.tb00645.x.

    PMID: 2082242BACKGROUND

  • 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. doi: 10.1177/00220345940730060701.

    PMID: 8046106BACKGROUND

  • 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.

    PMID: 18181730BACKGROUND

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

    PMID: 20613927BACKGROUND

MeSH Terms

Conditions

HalitosisChronic Periodontitis

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsPeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic Processes

Study Officials

  • Darije Plančak, Professor

    University of Zagreb

    STUDY DIRECTOR

Central Study Contacts

Larisa Musić, DMD

CONTACT

lmusic@sfzg.hr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Dental Medicine

Study Record Dates

First Submitted

April 4, 2016

First Posted

June 3, 2016

Study Start

June 1, 2016

Primary Completion

September 1, 2016

Last Updated

June 3, 2016

Record last verified: 2016-05

Locations

CR(1)