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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Geneva, Switzerland

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • 3/d 500 mg Amoxicilline Sandoz plus 500 mg Flagyl for 7 days
  • 3/d 500 mg Amoxicilline Sandoz plus 500 mg Flagyl for 3 days
  • 1/d 500 mg Azithromycine Pfizer for 3 days

Treatment groups

45 Participants
are divided into 3 treatment groups

Sponsors and collaborators

University of Geneva, Switzerland

Lead sponsor

University of Lausanne

Collaborator