EUCTR2016-001916-39-IT
Active, not recruiting
Phase 1
A phase IV, single-blind, randomized, controlled, single-center study evaluating the efficacy of amoxicillin+clavulanic acid Vs no treatment in preventing complications after tooth extraction and the efficacy of a probiotic in preventing antibiotic adverse effect - AB0001
Conditionsteeth needing extraction due to infectionsMedDRA version: 21.1Level: PTClassification code 10062132Term: Tooth extractionSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0Level: PTClassification code 10044034Term: Tooth disorderSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- teeth needing extraction due to infections
- Sponsor
- AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA
- Enrollment
- 150
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Female and male patients seeking Oral Dental Care at UO Odontostomatologia e Chirurgia del Cavo Orale” and needing dental extractions due to an ongoing infection.
- •\- Adult patients (\=18 year old)
- •\- Subjects capable of giving informed consent
- •\- Subjects who are women of childbearing potential must agree to utilize a highly effective contraceptive measure throughout the course of the study for the entire duration of the trial and the subsequent 60\-day follow\-up
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 100
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 50
Exclusion Criteria
- •\- Patients requiring third molar extractions
- •\- General contraindications to oral surgery
- •\- Immunosuppressed or immunocompromised patients
- •\- Patients under therapy with aminobisphosphonates i.v
- •\- Head and neck irradiation
- •\- Pregnancy and breastfeeding
- •\- Uncontrolled diabetes
- •\- Patients suffering from infectious mononucleosis
- •\- Patients suffering from colitis
- •\- Patients suffering from renal failure
Outcomes
Primary Outcomes
Not specified
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