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.

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
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• 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

Locations
Other Locations
Switzerland
University of Geneva, University Clinics of Dental Medicine
RECRUITING
Geneva
Contact Information
Primary
Catherine Giannopoulou, Dr med dent
ekaterini.giannopoulou@unige.ch
0041223794068
Backup
Alkisti Zekeridou, Dr med dent
alkisti.zekeridou@unige.ch
0041223794031
Time Frame
Start Date: 2021-09-01
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 45
Treatments
Active_comparator: Amoxicilline and Metronidazole for 7 days
Drug: AMOXICILLINE Sandoz cpr pell 500mg, Sandoz Pharmaceuticals AG + FLAGYL cpr pell 500mg, Sanofi-Aventis ( Suisse) SA, 3/d for 7 days~Systemic antibiotics after sub gingival mechanical debridement
Active_comparator: Amoxicilline and Metronidazole for 3 days
Drug: AMOXICILLINE Sandoz cpr pell 500mg, Sandoz Pharmaceuticals AG + FLAGYL cpr pell 500mg, Sanofi-Aventis ( Suisse) SA, 3/d for 3 days~Systemic antibiotics after sub gingival mechanical debridement
Active_comparator: Azithromycine for 3 days
Drug: AZITHROMYCIN Pfizer cpr pell 500mg, Pfizer PFE Switzerland GmbH~1/d 500mg for 3 days~Systemic antibiotics after sub gingival mechanical debridement
Related Therapeutic Areas
Sponsors
Leads: University of Geneva, Switzerland
Collaborators: University of Lausanne

This content was sourced from clinicaltrials.gov