The improvement effect of probiotics using tablet containing Lactobacillus salivarius WB21 on bad breath

A double-blind, randomized, placebo-controlled crossover trial of a Lactobacillus salivarius WB21-containing tablet for treatment of oral malodor

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN74332440

Enrollment

Registered

2013-01-10

Start date

2010-06-01

Completion date

Unknown

Last updated

2021-01-05

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

Conditions

Oral malodor Signs and Symptoms Halitosis

Interventions

The tablets (MINNA NO ZENDAMAKIN WB21 TABLET®

Wakamoto Pharmaceutical Co., Tokyo, Japan) contained 6.7 × 108 colony-forming units (CFU) of L. salivarius WB21 and 280-mg xylitol per tablet. Placebo samples contained only xylitol (

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 26 eligible patients (22 females and four males; mean age, 43.5 ± 11.5 years; age range, 22?67 years) 2. Oral malodor above a questionable level (OLT score = 1.5) 3. Not currently visiting a dentist for treatment 4. No acute symptoms requiring immediate oral cavity treatment 5. No use of probiotic supplements 6. No antibiotic use within the last month 7. No daily smoking habit 8. No systemic illness 9. No adverse reactions to lactose or fermented milk products

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria 56 were excluded: 48 did not meet the inclusion criteria, three refused to participate, and five had personality traits that were considered difficult for adherence to the protocol.

Design outcomes

Primary

Measure	Time frame
1. Organoleptic (OLT) score: The OLT scores were estimated by two of the three evaluators (with training and experience in calibration tests) using a scale of 0 to 5 (0, absence of oral malodor; 1, questionable odor; 2, slight malodor; 3, moderate malodor; 4, strong malodor; 5, severe malodor), and the mean of the scores given by the evaluators was used. 2. Total volatile sulfur compounds concentration: The total VSCs condition was measured by gas chromatography 3. Periodontal health: Periodontal health was assessed using the average probing pocket depth (PPD) and the number of bleeding on probing (BOP) sites. PPD and BOP were measured at six points around each tooth in all subjects. 4. Plaque control was evaluated using the Silness Löe Plaque Index 5. Degree of tongue coating was determined by tongue coating score (TCS): 0, no tongue coating; 1, thin tongue coating covering less than one-third of the tongue dorsum; 2, thick tongue coating covering approximately one-third of the tongue dorsum or thin tongue coating covering one-third to two-thirds of the tongue dorsum; 3, thick tongue coating covering one-third to two-thirds of the tongue dorsum or thin tongue coating covering more than two-thirds of the tongue dorsum; and 4, thick tongue coating more than two-thirds of the tongue dorsum. 6. Volume of stimulated salivary flow was measured using the chewing gum test. The patient was asked to pool saliva in the oral cavity and spit into a vessel each minute throughout a 5-min collection period.	—

Measure

Time frame

1. Organoleptic (OLT) score: The OLT scores were estimated by two of the three evaluators (with training and experience in calibration tests) using a scale of 0 to 5 (0, absence of oral malodor; 1, questionable odor; 2, slight malodor; 3, moderate malodor; 4, strong malodor; 5, severe malodor), and the mean of the scores given by the evaluators was used. 2. Total volatile sulfur compounds concentration: The total VSCs condition was measured by gas chromatography 3. Periodontal health: Periodontal health was assessed using the average probing pocket depth (PPD) and the number of bleeding on probing (BOP) sites. PPD and BOP were measured at six points around each tooth in all subjects. 4. Plaque control was evaluated using the Silness Löe Plaque Index 5. Degree of tongue coating was determined by tongue coating score (TCS): 0, no tongue coating; 1, thin tongue coating covering less than one-third of the tongue dorsum; 2, thick tongue coating covering approximately one-third of the tongue dorsum or thin tongue coating covering one-third to two-thirds of the tongue dorsum; 3, thick tongue coating covering one-third to two-thirds of the tongue dorsum or thin tongue coating covering more than two-thirds of the tongue dorsum; and 4, thick tongue coating more than two-thirds of the tongue dorsum. 6. Volume of stimulated salivary flow was measured using the chewing gum test. The patient was asked to pool saliva in the oral cavity and spit into a vessel each minute throughout a 5-min collection period.

—

Secondary

Measure	Time frame
1. Volatile sulfur compound concentration 2. The number of each probing depth 3. The number of oral bacteria in the saliva	—

Countries

Japan

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026