Phase 2 N=45 Randomized Double-blind Treatment

Inulin and S. Salivarius Reduce Halitosis

Halitosis · Tongue Diseases

Bottom Line

View on ClinicalTrials.gov: NCT02794766 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2020

Primary outcome: Primary: Halitosis Measured by Organoleptic Test — 3.2; 3.2; 2.9; 1.4 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Inulin+SS (Drug); S salivarius (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Universidade de Passo Fundo
Primary completion: May 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Halitosis Measured by Organoleptic Test	3.2; 3.2; 2.9; 1.4; 1.8; 1.7	—
PRIMARY Coating Index	2.2; 2.1; 2.0; 1.3; 1.7; 1.4	—
PRIMARY Halitosis Measured by Halimeter	181; 197; 187; 100; 125; 149	—
SECONDARY Oral-health Related Quality of Life	8.8; 5.7; 6.7; 5.6; 4.9; 6.6	—

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02794766). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.