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

NCT04669717 · tracked via the Priya Life Science Switzerland tracker

Sponsor

University of Geneva, Switzerland

Phase

Phase 4

Started

2021-09-01

Last updated

2026-04-29

Condition(s) studied

Periodontal DiseasesAntibioticsPharmacokinetics

Investigational drug(s) / intervention(s)

3/d 500 mg Amoxicilline Sandoz plus 500 mg Flagyl for 7 days3/d 500 mg Amoxicilline Sandoz plus 500 mg Flagyl for 3 days1/d 500 mg Azithromycine Pfizer for 3 days

3/d 500 mg Amoxicilline Sandoz plus 500 mg Flagyl for 7 days: Non-surgical periodontal therapy and radnomly administration of the antibiotics

3/d 500 mg Amoxicilline Sandoz plus 500 mg Flagyl for 3 days: Non-surgical periodontal therapy and radnomly administration of the antibiotics

1/d 500 mg Azithromycine Pfizer for 3 days: Non-surgical periodontal therapy and radnomly administration of the antibiotics

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Accepted

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Persons who have a confirmed or suspected intolerance to 5-nitroimidazole derivatives or amoxicillin or macrolides * Previous periodontal therapy the last 1 year * Known or suspected non-compliance, drug or alcohol abuse * Inability to follow due to language problems, psychological disorders, dementia, etc. of the participant * Participants not willing to attend regular dental maintenance visits and follow-up evaluations * Participation in another study with investigational drug within the 30 days preceding and during the present study

Primary outcome measure(s)

The concentration of AMO+MET and AZI in GCF, saliva and serum — At Day 0,2,4,8 post-dose
The concentration of the drugs will be assessed in samples of gingival crevicular fluid, saliva and serum at days 0, 2, 4 and 8 after the start of the antibiotic administration.The concentration of the studied antibiotics in the different fluids will be expressed as ng/ml

Trial sites (1)

Facility	City	Region	Status
University of Geneva, University Clinics of Dental Medicine	Geneva	Canton of Geneva	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04669717 on ClinicalTrials.gov ↗ ← All trials in Switzerland