A preliminary study to evaluate effectiveness of Korean medicine treatment for periodontal disease
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0009294
- Lead Sponsor
- Dongguk University Ilsan Oriental Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 45
(1) Individuals aged 20 years and above but below 65 years, regardless of gender.
(2) Those diagnosed with gingivitis and mild periodontitis.
(3) Individuals who voluntarily provided written consent to this human application trial through the Informed Consent Form.
(1) Patients with severe or advanced periodontitis.
(2) Individuals who have undergone scaling and preventive periodontal treatment within the last 3 months from the date of consent form completion.
(3) Smokers.
(4) Individuals with orthodontic appliances.
(5) Those with pathological findings in the oral tissues or requiring treatment from other departments.
(6) Individuals requiring immediate treatment for dental caries.
(7) Individuals with uncontrolled chronic conditions such as diabetes, liver disease, heart disease, kidney disease, bleeding disorders, or other chronic illnesses.
(8) Those with clinically significant immune, infectious, neoplastic, or psychiatric disorders requiring treatment.
(9) Users of medications that may affect periodontal health (nifedipine, phenytoin, cyclosporine).
(10) Those who have taken antibiotics within the last 4 weeks, are currently taking antibiotics, or are planning to receive antibiotics in the future.
(11) Individuals who have received investigational drugs or non-investigational medicinal products for clinical trials within 30 days prior to participating in the clinical trial.
(12) Pregnant or lactating women, or fertile women not using acceptable contraceptive methods.
(13) Individuals deemed unsuitable as subjects for this trial by the clinical trial investigator and personnel for reasons other than those mentioned above.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical outcomes(VAS, PD, BOP, GI, PI, EQ-5D-5L)
- Secondary Outcome Measures
Name Time Method Feasibility Outcomes (Recruitment Rate, Adherence Rate, Completion Rate);Economic Evaluation Indicators (Incremental Cost-Utility Ratio and Incremental Cost-Effectiveness Ratio between the Test Group and Control Group)