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Evaluation of the efficacy of probiotic on oral malodor

Evaluation of the efficacy of probiotic lozenges containing Streptococcus salivarius on oral malodor and quality of life of patients with halitosis

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20260413069067N1
Enrollment
60
Registered
2026-04-16
Start date
2026-04-21
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

oral malodor (Halitosis).

Interventions

Intervention 1: Intervention group: Intervention ProcedureIn the intervention group, participants receive a 5–10 minute, face-to-face oral hygiene instruction session delivered by a senior (final-year

Sponsors

Zist-Takhmir Pharmaceutical Company
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: individuals with halitosis confirmed by an examiner using organoleptic testing absence of systemic diseases affecting breath odor (diabetes, liver failure, gastrointestinal issues, etc. no use of antibiotics or antibacterial mouthwashes in the last two weeks no consumption of cigarettes or alcohol, not being pregnant or breastfeeding, and the ability to adhere to the study protocol (consuming probiotic pills)

Exclusion criteria

Exclusion criteria: Individuals who have halitophobia and halitosis of non-oral origin. Individuals who are taking antibiotics due to other infectious diseases. Individuals due to consumption of cigarettes and other tobacco products, and alcohol.

Design outcomes

Primary

MeasureTime frame
Halitosis severity (oral malodor). Timepoint: At baseline, and at weeks 4 and 8. Method of measurement: Assessed through the Halitosis Consultation Hour self-report questionnaire and based on the organoleptic test (evaluation of oral malodor intensity by the examiner’s sense of smell, using the nose without any instrument).Scores are interpreted as follows:• 0–1: Normal, no halitosis• >2: Indicates genuine halitosis• >3: Moderate to severe halitosis.;Halitosis Associated Life-Quality Test. Timepoint: At baseline, and at weeks 4 and 8. Method of measurement: It is a standardized and specialized questionnaire designed to assess the impact of halitosis (oral malodor) on individuals’ quality of life.A total score of:• Less than 30: Very little or no impact• 30–45: Mild to moderate impact• 46–60: Moderate to severe impact.;Self-assessment test for improvement of oral malodor. Timepoint: At baseline, and at weeks 4 and 8. Method of measurement: Assessment of the individual’s perception of changes in the severity of oral malodor, based on self-report.Scores are interpreted as follows:• 1: Significantly improved• 2: Improved• 3: No change• 4: Worsened• 5: Significantly worsened.;Tongue Coating Index. Timepoint: At baseline, and at weeks 4 and 8. Method of measurement: title: Tongue Coating Index for Assessing Dorsal Tongue Plaque CoverageDefinition and scoring:Area assessed: Dorsal surface of the tongueZonal mapping: The tongue dorsum is divided into 6 regionsScoring per region: Each region is scored based on plaque coverageTotal score: Sum of the 6 regional scoresInterpretation of total score:0–4: Oral halitosis unlikely5–9: Commonly observed in oral halitosis10–14: Strong association with oral halitosis15–18: Almost invariably present with oral halitosis.;Organoleptic Test. Timepoint: At baseline, and at weeks 4 and 8. Method of measurement: Organoleptic Assessment of Oral Malodor IntensityThe intensity of oral malodor is evaluated by the examiner’s sense of smell, using

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNastaran Najd

Karaj University of Medical Sciences

nastarannajd1993@gmail.com+98 26 3350 0080

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026