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

NCT04669717 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-04-29

No results posted yet for this study

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.

Conditions

  • Periodontal Diseases
  • Antibiotics
  • Pharmacokinetics

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

Sponsors & Collaborators

  • University of Lausanne

    collaborator OTHER

  • University of Geneva, Switzerland

    lead OTHER

Principal Investigators

  • Catherine Giannopoulou, Dr med dent · University Clinics of Dental Medicine, University of Geneva

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2028-12-01
Completion
2028-12-01

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04669717 on ClinicalTrials.gov