NCT04669717 Antibiotics as Adjuncts to Periodontal Therapy:Pharmacokinetic Considerations and Dosing Strategies
| NCT ID | NCT04669717 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Geneva, Switzerland |
| Condition | Periodontal Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2021-09-01 |
| Primary Completion | 2028-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 45 participants in total. It began in 2021-09-01 with a primary completion date of 2028-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Periodontitits is a bacteria induced inflammatory disease that destroys the supporting tissues of the tooth and leads to tooth loss. Treatment consists mainly of the mechanical cleaning of the tooth surfaces in order to remove the bacterial deposits (plaque and calculus). This procedure can reduce the level of pathogenic bacteria but it can not eradicate them. In severe cases, for the complete resolution of the disease, the elimantion of certain species of bacteria is needed. In order to achieve that, the combination of different regimens of antibiotics adjunctive to the mechanical treatment has been proposed. However, dosage and duration of antimicrobial therapy should be optimal and not excessive as issues may arise related to increased antimicrobial resistance in the population and the individual due to habitual prescription of wide-spectrum antibiotic regimens, horizontal gene transfer and genetic mutation. In the present study, in an effort to optimize the dosage and duration of the antimicrobial regimen, we will determine the pharmacokinetics (PK) and pharmacodynamic (PD) properties of the MET-AMO combination and of AZI in Gingival Crevicular Fluid (GCF), saliva and serum in severe periodontitis patients during and after either a 3-day or a 7-day course of treatment.
Eligibility Criteria
Inclusion Criteria: * Informed Consent as documented by signature * Aged 18-80 years old with need of periodontal treatment associated with adjunctive antibiotic therapy * Presence of at least 30% of the teeth in the mouth with PD\>6mm and BOP Exclusion Criteria: * Persons with systemic illnesses (uncontrolled diabetes mellitus, cancer, human immunodeficiency virus, bone metabolic diseases or disorders that compromise wound healing, radiation, or immunosuppressive therapy) * Pregnancy or lactation * Persons who had taken AB within the previous 2 months * Persons who are taking nonsteroidal anti-inflammatory drugs * Persons who have a confirmed or suspected intolerance to 5-nitroimidazole derivatives or amoxicillin or macrolides * Previous periodontal therapy the last 1 year * Known or suspected non-compliance, drug or alcohol abuse * Inability to follow due to language problems, psychological disorders, dementia, etc. of the participant * Participants not willing to attend regular dental maintenance visits and follow-up evaluations * Participation in another study with investigational drug within the 30 days preceding and during the present study
Contact & Investigator
Catherine Giannopoulou, Dr med dent
PRINCIPAL INVESTIGATOR
University Clinics of Dental Medicine, University of Geneva
Frequently Asked Questions
Who can join the NCT04669717 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Periodontal Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04669717 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04669717 currently recruiting?
Yes, NCT04669717 is actively recruiting participants. Contact the research team at ekaterini.giannopoulou@unige.ch for enrollment information.
Where is the NCT04669717 trial being conducted?
This trial is being conducted at Geneva, Switzerland.
Who is sponsoring the NCT04669717 clinical trial?
NCT04669717 is sponsored by University of Geneva, Switzerland. The principal investigator is Catherine Giannopoulou, Dr med dent at University Clinics of Dental Medicine, University of Geneva. The trial plans to enroll 45 participants.