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

ISRCTN	ISRCTN74332440
DOI	https://doi.org/10.1186/ISRCTN74332440
Secondary identifying numbers	N/A

Submission date: 27/12/2012
Registration date: 10/01/2013
Last edited: 17/12/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Oral malodor (bad breath) is primarily the result of the breakdown of amino acids in the local debris of the oral cavity by the micro organisms. Because probiotics possess potential capacity for improving microbiota, it may improve oral malodor. Lactobacillus salivarius WB21 has been recognized as a probiotic for oral health, and we previously reported that oral administration of tablets containing L. salivarius WB21 improved oral malodor in a study. The aim in this study was to confirm the effect of probiotics using L. salivarius WB21 on bad breath.

Who can participate?
Eighty-two patients complaining of halitosis (bad breath) were assessed for study eligibility at the Oral Malodor Clinic of Fukuoka Dental College Medical and Dental Hospital, Japan between June 2010 and September 2011. The eligible participants were 26 patients (22 females and four males, age range, 2267 years). They were patients with oral malodor above a questionable level, not currently visiting a dentist for treatment, no acute symptoms requiring immediate oral cavity treatment, no use of probiotic supplements, no antibiotic use within the last month, no daily smoking habit, no systemic illness and no adverse reactions to lactose or fermented milk products.

What does the study involve?
The intervention (treatment) compared test tablets with placebo. All participants received the same treatment that ingested both tablets containing L. salivarius WB21 and placebo. Placebo samples contained only xylitol.

What are the possible benefits and risks of participating?
The participants have a chance of improving oral malodor by oral consumption of test tablets. There is not any side effect.

Where is the study run from?
The study took place at the Oral Malodor Clinic of Fukuoka Dental College Medical and Dental Hospital, Japan.

When is the study starting and how long is it expected to run for?
The participants were recruited between June 2010 and September 2011.

Who is funding the study?
This study was supported in part by a Grant-in-Aid for Young Scientists (no. 23792532), Grant-in-Aid for Scientific Research (no. 23593078) and a Grant-in-Aid for Advanced Science Research from the Ministry of Education, Culture, Sports, Science, and Technology, Japan.

Who is the main contact?
Nao Suzuki
naojsz@college.fdcnet.ac.jp

Contact information

Dr Nao Suzuki
Scientific

2-15-1, Tamura Sawara-ku
Fukuoka
814-0193
Japan

Email	naojsz@college.fdcnet.ac.jp

Study information

Study design	Randomized double-blind crossover placebo-controlled clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A double-blind, randomized, placebo-controlled crossover trial of a Lactobacillus salivarius WB21-containing tablet for treatment of oral malodor
Study objectives	Oral malodor is a common problem in humans. Most oral malodor originates directly from the oral cavity owing to conditions such as periodontitis, tongue debris, poor oral hygiene, deep caries, inadequately fitted restorations, and endodontic lesions. Oral malodor is primarily the result of microbial metabolism of amino acids in local debris in the oral cavity. The most common compounds associated with oral malodor are volatile sulfur compounds (VSCs), such as hydrogen sulfide (H2S) and methyl mercaptan (CH3SH). Lactobacillus salivarius WB21 has been recognized as a probiotic for oral health, and we previously reported that oral administration of tablets containing L. salivarius WB21 improved oral malodor in an open trial. In this study, we conducted a 14-day, double-blind, placebo-controlled, randomized crossover trial of tablets containing L. salivarius WB21 or placebo taken orally by patients having oral malodor to confirm the authenticity of the effect of this organism on oral malodor.
Ethics approval(s)	Ethics Committee for Clinical Research of Fukuoka Dental College and Fukuoka College of Health Sciences, July 2, 2008, approval number 125
Health condition(s) or problem(s) studied	Oral malodor
Intervention	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 (280 mg/tablet). The dose throughout the test period was maintained at three tablets per day, taken orally after eating. Subjects were directed to place a tablet on the tongue for a few minutes and allow it dissolve. The period that the patients had tablets was four weeks, 2 weeks for test tablets and 2 weeks for placebo tablets with a wash out period of 2 weeks.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Lactobacillus salivarius WB21
Primary outcome measure	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 outcome measures	1. Volatile sulfur compound concentration 2. The number of each probing depth 3. The number of oral bacteria in the saliva
Overall study start date	01/06/2010
Completion date	30/09/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	26 eligible patients (22 females and four males; mean age, 43.5 ± 11.5 years; age range, 2267 years)
Key inclusion criteria	1. 26 eligible patients (22 females and four males; mean age, 43.5 ± 11.5 years; age range, 2267 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
Key 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.
Date of first enrolment	01/06/2010
Date of final enrolment	30/09/2011

Locations

Countries of recruitment

Japan

Study participating centre

2-15-1, Tamura Sawara-ku

Fukuoka
814-0193
Japan

Sponsor information

Fukuoka Dental College (Japan)
University/education

c/o Nao Suzuki, DDS, PhD
Section of General Dentistry
Department of General Dentistry
Fukuoka
814-0193
Japan

Phone	+81 92 801 0411
Email	naojsz@college.fdcnet.ac.jp
Website	http://www.fdcnet.ac.jp
"ROR"	https://ror.org/04zkc6t29

Funders

Funder type

Government

Ministry of Education, Culture, Sports, Science, and Technology (Japan) - Grant-in-Aid for Young Scientists (no. 23792532), Grant-in-Aid for Scientific Research (no. 23593078) and a Grant-in-Aid for Advanced Science

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2014	17/12/2020	Yes	No

Editorial Notes

17/12/2020: Publication reference added.