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A 12 week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of Probiotics on Gingival Health

A 12 week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of Probiotics oraCMU on Gingival Health

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0007555
Enrollment
80
Registered
2022-07-25
Start date
2022-07-13
Completion date
Unknown
Last updated
2022-09-20

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

Conditions

None listed

Interventions

Sponsors

Chosun University Dental Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Those who have BOP (bleeding on probing) site of 10% or more in all teeth, and have one or more teeth with PD (Probing Depth) of 3 mm or more and 5 mm or less 2) Those with one or more teeth with a GI score of 2 or higher 3) Those who have at least 20 existing natural teeth (excluding implants) 4) A person who has agreed to participate in this clinical trial before the start of the clinical trial and has written a written consent

Exclusion criteria

Exclusion criteria: 1) Those who are currently being treated for severe cardiovascular, immune, gastrointestinal/liver and biliary system, kidney and urinary system, nervous system, musculoskeletal system, infectious disease, etc. 2) People with mental disorders such as schizophrenia, depression, and drug addiction 3) Those who developed cancer within the past 5 years 4) A person with a history of bleeding or a disease, or a person taking antiplatelet drugs or anticoagulants for prevention 5) Those who show serious pathological findings in the soft tissues of the oral cavity 6) Those who need treatment such as surgery or tooth extraction due to accompanying orthodontic or dental disease during the clinical trial period 7) Based on Visit 1, women within 6 months of giving birth 8) Smokers 9) Those who received scaling treatment within 3 months of visit 1 or periodontal treatment within 6 months 10) Those who have taken drugs that can affect periodontal condition (Phenytoin, CCBs, Cyclosporine, Coumadin, NSAIDs, Aspirin, etc.) for 5 or more consecutive days within 1 month based on Visit 1 11) Those who have taken antibiotics or supportive drugs for periodontal disease within 1 month based on visit 1 12) Those who have consumed health functional food related to gingival health within 1 month based on visit 1 13) Those who have consumed probiotics, prebiotics, or lactobacillus products continuously (4 or more times a week) within 2 weeks of visit 1 14) Patients with uncontrolled hypertension (systolic blood pressure of 160 mmHg or higher or diastolic blood pressure of 100 mmHg or higher, measurement standard after subject resting for 10 minutes) 15) Patients with uncontrolled diabetes mellitus (fasting blood sugar of 180 mg/dL or higher, or starting medication for diabetes within 3 months) 16) Those whose creatinine is more than twice the normal upper limit of the implementing institution 17) Those whose AST(GOT) or ALT(GPT) is more than 3 times the upper limit of normal 18) Those who are pregnant, lactating, or planning to become pregnant during this human application test period 19) Those who have participated in other interventional clinical trials (including human trials) within 3 months of Visit 1, or plan to participate in other interventional clinical trials (including human trials) after the start of this human trial 20) Those who are sensitive to or allergic to the food ingredients for this clinical trial 21) Those who are judged inappropriate by the investigator for other reasons

Design outcomes

Primary

MeasureTime frame
Gingival index

Secondary

MeasureTime frame
Pocket depth (Periodontal proving depth);Clinical attachment level;Plaque index;Bleeding on proving;Gingival recession;Biomarkers in gingival crevicular fluid;Oral bacteria;OHIP-14 (Oral Health Impact Profile-14)

Countries

Korea, Republic of

Contacts

Public ContactHyun-Seung Noh

Chosun University Dental Hospital

hm03003@naver.com+82-62-220-3854

Outcome results

None listed

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