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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
3/d 500 mg Amoxicilline Sandoz plus 500 mg Flagyl for 7 days
DrugNon-surgical periodontal therapy and radnomly administration of the antibiotics
3/d 500 mg Amoxicilline Sandoz plus 500 mg Flagyl for 3 days
DrugNon-surgical periodontal therapy and radnomly administration of the antibiotics
1/d 500 mg Azithromycine Pfizer for 3 days
DrugNon-surgical periodontal therapy and radnomly administration of the antibiotics
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: Amoxicilline and Metronidazole for 7 daysActive comparator 1 intervention
Group B: Amoxicilline and Metronidazole for 3 daysActive comparator 1 intervention
Group C: Azithromycine for 3 daysActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The concentration of AMO+MET and AZI in GCF, saliva and serum
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
Time frame
At Day 0,2,4,8 post-doseSecondary outcomes
1
Differences between the three treatment arms in the proportion of participants classed as treatment success at 6 months; defined as absence of sites with PD ≥ 5 mm and concomitant bleeding on probing.
Comparisons between groups assessed at 3 and 6 months after treatment
Time frame
At Month 3 and Month 6 post-intervention2
Differences between the three treatment arms in the levels of 6 organisms in subgingival plaque samples. For those bacteria with a threshold of >1000cells/ml, results will be expressed as median counts.
Comparisons between groups will be assessed at 3 and 6 months after treatment
Time frame
At Month 3 and Month 6 post-intervention3
Number of participant per treatment arm with adverse events as a mesure of safety.
Adverse events will be collected from the start of study treatment and until the end of the study (at 6 months evaluation)
Time frame
At Day 2, Day 4 and Day 8 post-intervention4
Patient's compliance will be evaluated
Compliance will be evaluated by pill count at the end of the antibiotherapy.
Time frame
At Day 8 after interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Geneva, Switzerland
Lead sponsor
University of Lausanne
Collaborator
Source ClinicalTrials.gov