Clinical Trial: Inulin and S. Salivarius Reduce Halitosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Inulin and Streptococcus Salivarius Reduce Halitosis Associated With Tongue Coating: A Randomized Clinical Trial

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.

Detailed Summary: In this double-blind, randomized, phase II trial, 45 patients (35 ± 15 years, 66% women) with halitosis by coating were allocated to three treatment groups (n = 15) using gum of oral dissolution for 10 days, containing: inulin+SS, SS and placebo. Organoleptic test, Halimeter®, coating index and evaluation of quality of life (OHIP-14 and WHOQOL-Bref) were performed before and after treatments. Generalized estimating equations were used to evaluate the effects.
Sponsor: Universidade de Passo Fundo

Current Primary Outcome: Halitosis [ Time Frame: 10 days ]

measured by organoleptic test and Halimeter®


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Coating index [ Time Frame: 10 days ]
    Evaluated by a trained judge during oral examination
  • General health-related quality of life [ Time Frame: 14 days ]
    WHOQOL-Bref
  • Oral-health related quality of life [ Time Frame: 14 days ]
    OHIP-14
  • Number of participants with side effects potentially linked to treatments [ Time Frame: 10 days ]
    During the use of gums, patients were instructed to register the occurrence of the following symptoms (yes or not): headache, tongue discomfort and abdominal symptoms (pain, diarrhea and constipation).
  • Adherence to treatments [ Time Frame: 10 days ]
    Patients received 20 gums for 10 days of treatment (2 gums a day) and were instructed to return the gums not used


Original Secondary Outcome: Same as current

Information By: Universidade de Passo Fundo

Dates:
Date Received: May 15, 2016
Date Started: March 2014
Date Completion:
Last Updated: June 5, 2016
Last Verified: June 2016