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RECRUITING
NCT04669717
PHASE4

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

Sponsor: University of Geneva, Switzerland

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2021-09-01

Completion Date

2026-12-01

Last Updated

2024-05-08

Healthy Volunteers

Yes

Interventions

DRUG

3/d 500 mg Amoxicilline Sandoz plus 500 mg Flagyl for 7 days

Non-surgical periodontal therapy and radnomly administration of the antibiotics

DRUG

3/d 500 mg Amoxicilline Sandoz plus 500 mg Flagyl for 3 days

Non-surgical periodontal therapy and radnomly administration of the antibiotics

DRUG

1/d 500 mg Azithromycine Pfizer for 3 days

Non-surgical periodontal therapy and radnomly administration of the antibiotics

Locations (1)

University of Geneva, University Clinics of Dental Medicine

Geneva, Switzerland