Antibiotics as Adjuncts to Periodontal Therapy:Pharmacokinetic Considerations and Dosing Strategies
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Antibiotics
- Periodontal Diseases
- Pharmacokinetics
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized, 3-arm parallel group, single-blind, comparative superiority and exploratory clinical trial with 1:1 allocation ratio.Masking: Single (Investigator)Masking Description: The examiner, the biostatistician and people working in the laboratory for the analyses, will be blinded for the allocation group. Only the two operators and the participants will be aware of the type of treatment based on the computer-generated allocation table that will be kept at the Trial Master File (TMF) of the study.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
Description
This is a randomized, 3-arm parallel group, single-blind, comparative superiority and exploratory clinical trial of 44 months involving 45 patients with periodontitis attending the Division of Regenarative Dental Medecine and Periodontology of the University of Geneva. First, a routine clinical and ...
This is a randomized, 3-arm parallel group, single-blind, comparative superiority and exploratory clinical trial of 44 months involving 45 patients with periodontitis attending the Division of Regenarative Dental Medecine and Periodontology of the University of Geneva. First, a routine clinical and radiographic periodontal examination will be conducted by a periodontist. Treatment will be done in 2 appointments by mechanical debridement of the diseased sites by two experienced clinicians. At the end of the treatment, one third of the patients will be assigned for treatment with 500mgAMO+ 500mgMET 3 times a day during 1 week, one third for treatment with 500mgAMO+ 500mgMET 3 times a day during 3 days and the last third for treatment with 500mg AZI once a day for 3 days. Clinical samples will be taken at Days 0, 2, 4 and 8 after the start of the antibiotic administration . Gingival Crevicular Fluid (GCF) will be collected from four sites with paperpoints, blood sample by finger puncture, unstimulated saliva and subgingival plaque from four sites with paper points. The concentration and duration effect of AMO+MET and AZI in GCF, saliva and serum will be assessed in the Laboratory of Clinical Pharmacology at the University Hospital of Lausanne (CHUV) by high performance liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS). The microbiological effect on 6 selected organisms will be assessed by RT-PCR at 3 and 6 months after treatment. The clinical results will be evaluated 6 months later. The study duration for the patient will be approximately 8 months. All adverse events (AE) and all serious adverse events (SAEs) will be recorded and addressed.
Tracking Information
- NCT #
- NCT04669717
- Collaborators
- University of Lausanne
- Investigators
- Principal Investigator: Catherine Giannopoulou, Dr med dent University Clinics of Dental Medicine, University of Geneva
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