None listed
Conditions
Interventions
Drug : In the methotrexate group, MTX will be administered orally once weekly, starting at 7.5 mg/week. After safety evaluation (including adverse events, vital signs, physical examination, body weigh
Sponsors
Yonsei University Health System, Dental Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subject consent form signed by members aged 19 to 55 2) Patients with Stage III/IV Grade C periodontitis meeting the following criteria A. One or more criteria corresponding to Stage III/IV: ? Max interdental movement loss: = 5 mm ? Ethnic bone loss: Including the medial 1/3 to the motor 1/3 ? Placement location: Present ? Probing method: - Probing range = 6 mm - Transverse bone loss + transverse bone loss = 3 mm - Grade II or III furcation structure - Severe prescription defect B. One or more criteria corresponding to Grade C: ? Arthritic bone resorption or clinical tissue loss: = 2 mm at 5 years ? % bone loss/age: > 1.0 ? Thumb phenotype: Expected periodontal resolution to plaque fluid 3) Non-surgical dental treatment at the last maintenance (scaling, surface planing, dental hygiene education, removal of plaque retention factors, teeth Those requiring additional treatment for two or more teeth with a fixed periodontal pocket width of 6 mm or more and a loss of movement of 5 mm or more, despite having received treatment for caries, occlusion, or adjustable treatment within the last three months 4) Those with 15 or more teeth present 5) Oral Plaque Score (FMPS) = 20% 6) Those who voluntarily decided to participate after receiving a clear explanation of this clinical trial and signed to comply with the precautions
Exclusion criteria
Exclusion criteria: 1) Patients for whom administration is contraindicated according to the approved indications for drugs administered concomitantly with methotrexate and rituximab (folic acid in the methotrexate group, and pretreatment drugs such as acetaminophen, chlorpheniramine maleate, and methylprednisolone in the rituximab group) (however, not limited to the following): A. Patients with renal impairment (CLCr = 60 mL/min) and hepatic impairment (AST or ALT = 3 x ULN) B. Patients with active, severe infections or severe immune impairment C. Patients positive for HBsAg or anti-HBc antibodies D. Patients positive for anti-HIV antibodies E. Patients with pleural effusion or ascites, etc. F. Patients with pre-existing hematological disorders such as myelodysplastic syndrome, leukopenia, thrombocytopenia, or severe anemia (e.g., patients with pernicious anemia or megaloblastic anemia due to vitamin B12 deficiency) G. Patients with alcoholism, alcoholic liver disease, Patients with chronic liver disease H. Patients currently receiving acitretin 2) Individuals with significant oral diseases (e.g., xerostomia, stomatitis, oral ulcers) and/or systemic diseases (e.g., diabetes, cardiovascular disease, respiratory disease, autoimmune disease [rheumatoid arthritis, systemic lupus erythematosus, psoriasis, Crohn's disease, myasthenia gravis, Hashimoto's thyroiditis, etc.]) that may affect the clinical trial in addition to periodontitis 3) Individuals currently receiving or requiring methotrexate, rituximab, and/or other immunosuppressants for reasons other than periodontitis 4) Individuals currently receiving drugs that may affect periodontal tissues (e.g., anticoagulants, vitamin E supplements) 5) Active ingredients of the investigational medicinal products (methotrexate and rituximab) and concomitantly administered drugs (folic acid in the methotrexate group, and the pretreatment drugs acetaminophen, chlorpheniramine maleate, and methylprednisolone in the rituximab group) Persons with hypersensitivity to the components 6) Persons with genetic issues such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 7) Persons who received a vaccination within 4 weeks prior to the first administration of the investigational medicinal product, or persons who require or are scheduled to receive a live vaccine during the administration period of the investigational medicinal product 8) Smokers 9) Women who are currently pregnant, may become pregnant, or are planning to become pregnant, and breastfeeding women 10) Persons for whom less than 1 month has elapsed since receiving a treatment contraindicated for concomitant use (Sections 6.7.1 1 and 2) prior to participating in this clinical trial 11) Persons for whom 5 times the half-life has not elapsed since receiving a drug contraindicated for concomitant use (Sections 6.7.1 3, 4, and 5) prior to participating in this clinical trial 12) Based on the date of the last administration of the investigational medicinal product from the time of subject consent Those who do not agree to use the contraceptives permitted in this study for up to 12 months, and those who do not agree not to donate sperm/eggs during that period 13) Others, those deemed unsuitable for participation in this clinical trial by the researchers (dental specialists and internal medicine specialists)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of TEAE after administration, changes in laboratory tests, vital signs, 12-lead ECG, and physical examination results compared to baseline;Evaluation of periodontal indices (CAL, PD, GI, BOP, TL, MBL, Tooth mobility, PI) in the whole arch after administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient-reported outcome measurements (OHIP-14 and VAS), Biomarkers (GCF IgM and IgG, plasma IgM and IgG), GCF drug concentration | — |
Countries
Korea, Republic of
Contacts
Public ContactSeulbin Im
Yonsei University Health System, Dental Hospital
Outcome results
None listed