Identification and characterization of antimicrobial antibodies in the serum of patients with periodontitis
- Conditions
- K05Gingivitis and periodontal diseases
- Registration Number
- DRKS00032671
- Lead Sponsor
- Abteilung für Zahnerhaltung & Parodontologie // Klinik für Zahn- Mund- und Kieferheilkunde
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 200
The following general criteria must be met for inclusion in the study:
- Capacity to provide informed consent
- Patients with periodontitis as well as individuals without a diagnosis of periodontitis, provided all other inclusion criteria are met, and no exclusion criteria apply.
Additionally, the following criteria must be checked and satisfied immediately before blood collection:
- Puncture site: Free from lesions or infections
- Presence of a signed informed consent form for participation in the study
- Existing cytopenias (leukocytes <1,500/µl, platelets <50,000/µl, or hemoglobin <12 g/dl)
- Cardiac complications (e.g., pulmonary arterial hypertension).
- Presence of infectious diseases.
- No blood sample collection for B-cell isolation in individuals with a body weight <50 kg
- Blood donation or significant blood loss (e.g., surgery) within the last 8 weeks (men) or 12 weeks (women).
- Blood pressure: systolic: 100–180 mm Hg, diastolic: below 100 mm Hg.
- Pulse: within the normal range, frequency 50–110/min; potential donors engaged in intense sports activities with a pulse rate below 50/min may be considered.
- Within one week after minor surgery (e.g., biopsy, tooth extraction, etc.), or 2 or 3 months (as mentioned above) after major surgery (e.g., involving the opening of the chest cavity or abdominal cavity) or any other surgery with an increased risk of post-operative bleeding
- Any deterioration in the general health status, e.g., weight loss >2 kg, diabetic metabolic state, pulmonary exacerbation, or loss of lung function (FEV1 > 10%) in the past 3 months
- No fever
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The identification of functional antibodies from the sera of periodontitis patients with a long-standing history and/or progressive form of periodontitis (Grade C) involves titration of blood sera against potent virulence factors of the key periodontal pathogen Porphyromonas gingivalis (PA strain), followed by the establishment of various immunological assays utilizing sera from patients with particularly high titers.<br>Isolation of B cells from sera exhibiting particularly inhibitory antibodies, followed by subsequent antibody production.<br>In vitro testing of the generated antibodies.
- Secondary Outcome Measures
Name Time Method ew insights into the relationships between immunological processes and clinical parameters