Status:
RECRUITING
Antibiotics as Adjuncts to Periodontal Therapy:Pharmacokinetic Considerations and Dosing Strategies
Lead Sponsor:
University of Geneva, Switzerland
Collaborating Sponsors:
University of Lausanne
Conditions:
Periodontal Diseases
Antibiotics
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 s...
Detailed 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 Regenar...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04669717
Start Date
September 1 2021
End Date
December 1 2026
Last Update
May 8 2024
Active Locations (1)
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1
University of Geneva, University Clinics of Dental Medicine
Geneva, Switzerland, 1205