Health Condition 1: K055- Other periodontal diseases
Conditions
Interventions
Intervention1: YH23537: 2 tablets 2 times a day for 12 weeks
Control Intervention1: Placebo: 2 tablets 2 times a day for 12 weeks
Sponsors
Yuhan Care Co., Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1.Participants aged 20 ââ?¬â?? 80 years old (both inclusive) 2.Those with a probing pocket depth of 3 to 5 mm. 3. Participants with more than 20 or more existing natural teeth 4. Participants with symptoms of gingivitis or mild periodontitis 5.Participant with more than 10% BOP site and those who have at least one tooth with PD of more than 3mm and less than 5mm (inclusive of 5mm). 6.Participant with at least one site of bleeding while probing. 7.Participants who voluntarily agrees to participate and signs on informed consent form
Exclusion criteria
Exclusion criteria: 1.Participants who are allergic to the main ingredient of the investigational product. 2.Participants who smoked within 12 months prior the screening visit 3.Participant who has 5 or more teeth that need immediate dental caries treatment in the oral cavity. 4.Participants who have received prophylaxis and/or any other periodontal therapy within 6 months from the screening visit. 5.Participants who have received scaling within 1 month of the start of the study 6.Participants with bleeding control disease and being medicated with anticoagulant and/or antithrombotic agent 7.Those who show serious pathological findings in the soft tissues of the oral cavity 8.Patients with periodontitis requiring surgery or treatment such as tooth extraction 9.Those who have taken drugs that may affect periodontal condition (phenytoin, CCBs, cyclosporine, coumadin, NSAIDs, aspirin, etc.) for more than 5 consecutive days within the last 1 month 10.Those who have taken antibiotics, supplementary treatment for periodontal disease previous 1 month of screening visit. 11.Participants with uncontrolled diabetics, fasting glucose of more than 180mg/dL and is being medicated to treat diabetes 12.Participants with high blood pressure, more than 160/100mmHg 13.Participants with the history of cancer in past 5 years 14.Excessive alcohol consumption ( > 20 g/day) 15.Participants with mental disorders such as schizophrenia, depression, drug addiction, alcoholism, etc. 16.Participants who are pregnant or lactating participants, or women of childbearing age who do not agree to use contraception during the trial 17.Those who have participated in another clinical trial previous 1 month of screening visit or plan to participate during the clinical trial period 18.Participants taking health functional food that affect gum health within 1 month prior to screening 19.Participants who are deemed unable to comply with the test requirements or otherwise deemed unsuitable according to the investigatorââ?¬•s opinion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Attachment LevelTimepoint: Baseline, week 4, week 8, and week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Bleeding on probing-at least in one siteTimepoint: Baseline, week 4, week 8, and week 12;Gingival IndexTimepoint: Baseline, week 12;IL-1beta, TNF-alpha in gingival fluidTimepoint: Baseline, week 12;Oral health related quality of life questionnaireTimepoint: Baseline, week 12;Organoleptic Scoring Scale for HalitosisTimepoint: Baseline, week 12;Plaque IndexTimepoint: Baseline, week 12 | — |
Countries
India
Contacts
Public ContactSubham Dutta
Syncorp Health Pvt Ltd
Outcome results
None listed