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Clinical Trial for the Evaluation of the Efficacy and Safety on Oral Anti-Microbial and Halitosis

A Randomized, Double-blind, placebo-controlled, Mult I-center Clinical Trial to Evalujate the Efficacy and Safety of Igatan Fcapsule in non-surgical therapy of peri-implantitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0009894
Enrollment
80
Registered
2024-11-01
Start date
2023-02-06
Completion date
Unknown
Last updated
2024-11-14

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 : Take test food(1.0 x 10? CFU/day as L. gasseri HHuMIN D and L. paracasei OK complex) or placebo(800 mg/tablet as isomalt and sorbitol) once a day, 1 tablet, and oral intake before

Sponsors

Dankook University Dental Hostipal
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Adult men and women aged 19 or older and 70 or younger 2) A person who has at least two of three specific harmful bacteria (F.nucleatum, P.gingivalis, and P.intermedia) in oral microbiological measurements 3) Those with a sum of H2S, CH 3 SH, and (CH 3)2S greater than 2.0 ng/10mL in VSC examination on Visit 1 and Visit 2 4) A person who has agreed to participate in the human body application test before the commencement of the human body application test and has completed a written consent form

Exclusion criteria

Exclusion criteria: 1) severe cardiovascular system, immune system, respiratory system, urinary system, nervous system, musculoskeletal system, A person currently undergoing treatment for infectious diseases and malignant tumors, etc 2) A person who is currently being treated or has a history of systemic diseases that may cause bad breath (hepatic disease, kidney disease, Sjogren syndrome, rheumatoid disease), etc. (However, participation in the test may be made at the discretion of the examiner in consideration of the condition of the subject of the human body application test.) 3) Those with severe dental diseases (periodontitis, dental caries, dry mouth, etc.) (Enamel caries among dental caries can participate in the test, and if there is more than one dentine caries, not participating) 4) Those currently being treated for sinusitis and rhinitis 5) a person currently being treated for chronic gastritis 6) a current smoker 7) A person who is taking psychiatric drugs such as depression and Parkinson's disease treatment within one month as of visit 1 8) A person who has taken supplementary treatment for periodontal disease within 3 months based on visit 1 9) A person who has been scaled within 3 months of visit 1 10) A person who has administered antibiotics and intestinal medications within two weeks based on visit 1 11) A person who has administered or ingested probiotics, prebiotics, and lactobacillus products continuously (more than four times a week) within two weeks on the basis of visit 1 12) Uncontrolled hypertension patients (systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg, and measurement criteria after stabilizing for 10 minutes in human body application test subjects) 13) Uncontrolled diabetic patients (above 180 mg/dL fasting blood glucose) 14) A person whose AST (GOT) or ALT (GPT) is more than three times the upper limit of the agency's normal limit 15) A person whose creatine is more than twice the normal upper limit of the implementation agency 16) A person who is pregnant or is lactating or has a pregnancy plan during the main human body application test period 17) A person who is sensitive or allergic to food ingredients for this human application test 18) A person who has participated in another interventional clinical trial (including human application testing) within one month (30 days) as of visit 1, or who plans to participate in another interventional clinical trial (including human application testing) after the start of the personal application test 19) A person who is deemed inappropriate by the tester for the human body application test

Design outcomes

Primary

MeasureTime frame
Volatile Sulphur Compounds (VSC) with Oral Chroma

Secondary

MeasureTime frame
TPI(Tongue Plaque Index);GI(Gingival Index);PI(Plaque Index);improvement evaluation of human application test subjects;PHP Index(Patient Hygiene Performance Index);oral microorganism measurement;Organoleptic halitosis check

Countries

Korea, Republic of

Contacts

Public ContactJa-Won Cho

Dankook University Dental Hostipal

priscus@hanmail.net+82-41-550-1955

Outcome results

None listed

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