Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Inulin and S. Salivarius Reduce Halitosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02794766
Recruitment Status : Completed
First Posted : June 9, 2016
Results First Posted : August 19, 2020
Last Update Posted : August 19, 2020
Sponsor:
Collaborator:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by (Responsible Party):
Fernando Fornari, Universidade de Passo Fundo

Brief Summary:
Halitosis associated with tongue coating results from the production of volatile sulfur compounds by bacterial action. The use of prebiotics and probiotics might be useful in treating such condition. The aim of this study was to evaluate the effect of the prebiotic inulin combined with the probiotic Streptococcus salivarius (SS) on halitosis by coating.

Condition or disease Intervention/treatment Phase
Halitosis Tongue Diseases Drug: Inulin+SS Drug: S salivarius Drug: Placebo Phase 2

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Inulin and Streptococcus Salivarius Reduce Halitosis Associated With Tongue Coating: A Randomized Clinical Trial
Study Start Date : March 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bad Breath
Drug Information available for: Inulin

Arm Intervention/treatment
Experimental: Inulin+SS
Experimental treatment: A gum of inulin 1g plus Streptococcus salivarius 1 billion colony forming units (CFU) per oral each 12 hours for 10 days
Drug: Inulin+SS
Experimental treatment: A gum of inulin 1g plus Streptococcus salivarius 1 billion CFU per oral each 12 hours for 10 days
Other Name: Inulin plus Streptococcus salivarius

Active Comparator: S salivarius
Active comparator: A gum of Streptococcus salivarius 1 billion CFU per oral each 12 hours for 10 days
Drug: S salivarius
Active comparator: A gum of Streptococcus salivarius 1 billion CFU per oral each 12 hours for 10 days
Other Name: Streptococcus salivarius

Placebo Comparator: Placebo
Placebo 1 gum per oral each 12 hours, for 10 days
Drug: Placebo
Placebo 1 gum each 12 hours for 10 days




Primary Outcome Measures :
  1. Halitosis Measured by Organoleptic Test [ Time Frame: Halitosis measured by organoleptic test was performed before and 14 days after the treatments ]
    Unabbreviated scale title: Organoleptic test Minimum: 0 Maximum: 5 Higher score means worse outcome.

  2. Coating Index [ Time Frame: Coating index was evaluted before and 14 days after the treatments. ]
    Unabbreviated scale title: Coating index (evaluated by a trained judge during oral examination) Minimum: 0 Maximum: 4 Higher score means worse outcome.

  3. Halitosis Measured by Halimeter [ Time Frame: Halitosis measured by halimeter test was performed before and 14 days after the treatments ]
    Unabbreviated scale title: Halitosis measured by halimeter Minimum: 0 Maximum: 500 A score =>75 ppb means halitosis.


Secondary Outcome Measures :
  1. Oral-health Related Quality of Life [ Time Frame: Oral health impact profile -14 questionnaire was filled before and 14 days after the treatments ]
    Unabbreviated scale title: Oral-health related quality of life measured by Oral Health Impact Profile -14 questionnaire Manimum: 0 Maximum: 56 Higher scores mean worse outcome



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients with halitosis by tongue coating;
  • participants must accept to participate in the study;
  • tongue coating identified by oral examination;
  • halitosis must be confirmed by the organoleptic test.

Exclusion Criteria:

  • halitosis for other conditions, including periodontal diseases and non-oral conditions;
  • use of antibiotics in the last 30 days;
  • active smoking (>10 cigarettes/day);
  • alcohol consumption (>2 drinks/day);
  • report of pregnancy or breastfeeding;
  • report of systemic diseases, including diabetes, kidney failure and hepatic cirrhosis.

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): NCT02794766


Sponsors and Collaborators
Universidade de Passo Fundo
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Investigators
Layout table for investigator information
Principal Investigator: Fernando Fornari Universidade de Passo Fundo
Layout table for additonal information
Responsible Party: Fernando Fornari, Professor, Universidade de Passo Fundo
ClinicalTrials.gov Identifier: NCT02794766    
Other Study ID Numbers: CAAE40334914000005342
First Posted: June 9, 2016    Key Record Dates
Results First Posted: August 19, 2020
Last Update Posted: August 19, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Tongue Diseases
Halitosis
Signs and Symptoms, Digestive
Mouth Diseases
Stomatognathic Diseases