EUCTR2017-004986-28-AT
Active, not recruiting
Phase 1
Effect of systemic antibiotic therapy on postoperative complications in patients undergoing wisdom teeth removal surgery. A double-blind, randomised, placebo-controlled Trial - AMOXI
Medizinische Universität Graz, Klin. Abteilung für Orale Chirurgie und Kieferorthopädie0 sites59 target enrollmentFebruary 8, 2019
ConditionsSurgical extraction of third molarsMedDRA version: 20.0 Level: PT Classification code 10047991 Term: Wisdom teeth removal System Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0 Level: LLT Classification code 10038349 Term: Removal of wisdom teeth System Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Dentistry [E06]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Surgical extraction of third molars
- Sponsor
- Medizinische Universität Graz, Klin. Abteilung für Orale Chirurgie und Kieferorthopädie
- Enrollment
- 59
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-Symptom\-free, bilaterally located third molars
- •\-Medically healthy patient \= 16 years
- •\- No allergies/intolerances against the investigational product/placebo
- •\- Informed consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 34
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 5
Exclusion Criteria
- •\-General contraindications to wisdom tooth extraction surgery
- •\-(Former) heavy smoking
- •\-Use of antibiotics within the last three months or patients requiring antiobiotic treatment prior to surgery
- •\-(Planned) Pregnancy/lactating
Outcomes
Primary Outcomes
Not specified
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