RecruitingPhase 4NCT04669717

Antibiotics as Adjuncts to Periodontal Therapy:Pharmacokinetic Considerations and Dosing Strategies

Pharmacokinetic Considerations and Dosing Strategies of Amoxicillin and Metronidazole or Azithromycin as Adjunct to Non-surgical Periodontal Therapy. A Randomized,6-month, Parallel-group, Clinical Trial.

Sponsor

University of Geneva, Switzerland

Enrollment

45 participants

Start Date

Sep 1, 2021

Study Type

INTERVENTIONAL

Conditions

Antibiotics Periodontal Diseases Pharmacokinetics

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating the best way to use antibiotics as an add-on to periodontal (gum) therapy in patients with severe gum disease. Periodontitis is an advanced form of gum disease where bacteria deep under the gumline destroy the bone and tissue holding teeth in place. Standard treatment involves deep cleaning (scaling and root planing), but for severe cases, antibiotics are often prescribed alongside it. This study is specifically looking at the pharmacokinetics — how antibiotics are absorbed, distributed, and eliminated by the body — to figure out the optimal dosing strategy for adjunctive antibiotic therapy. Participants will receive periodontal treatment plus antibiotics, with blood and fluid samples collected to analyze drug levels over time. You may be eligible if: - You are between 18 and 80 years old - You have severe periodontitis (at least 30% of teeth have pocket depths above 6mm with bleeding) - You need periodontal treatment combined with adjunctive antibiotic therapy You may NOT be eligible if: - You have uncontrolled systemic illness such as uncontrolled diabetes, cancer, HIV, bone disease, or conditions that affect wound healing - You are pregnant or breastfeeding - You have taken antibiotics in the past 2 months - You are currently using non-steroidal anti-inflammatory drugs (NSAIDs) - You have a confirmed or suspected allergy to the antibiotics used in the study - You have had periodontal treatment in the past year Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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