The efficacy and safety of oraCMU on oral health

A 8 week, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of oraCMU on oral health

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0004291

Enrollment

100

Registered

2019-09-10

Start date

2019-09-06

Completion date

Unknown

Last updated

2019-10-07

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

Conditions

None listed

Interventions

Dietary Supplement : Within 2-week run-in period, enrolled subjects will be randomly assigned to treatment or placebo groups at visit 2 (week 0). The subjects will be asked to consume 1 tablet a day d

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Those who voluntarily agree to participate in this study and sign in informed consent form 2) Men and women between 20 and 70 years old 3) Those who have 20 or more natural teeth excluding wisdom teeth 4) Those who without tongue diseases 5) A person with volatile sulfur compounds concentration of 1.5 ng/10 ml or more 6) Persons without severe periodontal disease, rampant caries, less than five dental caries to be treated immediately

Exclusion criteria

Exclusion criteria: 1) Those who have communication problem with investigators 2) Those who have mental diseases 3) Those who are currently being treated with systemic disease that may cause bad breath 4) Those who have a diagnosis of sinusitis or rhinitis 5) Those taking antibiotics within 1 month before the first visit 6) Those who have a diagnosis of chronic gastritis 7) Those with uncontrolled hypertension 8) Diabetic patients taking hypoglycemic agents 9) Those who consume food or health functional food with probiotics within 1 week before the first visit 10) Those who have hypersensitivity or allergy to probiotics including dairy food 11) Those taking warfarin or aspirin 12) Those who have aspiration risk 13) Those who have dry mouth 14) Persons with severe periodontal disease, rampant caries, five or more dental caries to be treated immediately 15) Pregnant or lactating women, or with pregnancy plan during the study period 16) Those who have participated in other clinical trials within 6 months before participating in this study 17) Those who are deemed by the investigator to be unsuitable for this study

Design outcomes

Primary

Measure	Time frame
Halitosis, gingival index, periodontal bacteria	—

Secondary

Measure	Time frame
Psychosocial health survey;Blood test	—

Countries

Korea, Republic of

Contacts

Public ContactDajung Lee

Seoul National University Dental Hospital

dajueng90@gmail.com+82-2-2072-3055

Outcome results