Effect of the usage of antibiotic treatment in patients undergoing wisdom teeth removal surgery

Effect of systemic antibiotic therapy on postoperative complications in patients undergoing wisdom teeth removal surgery. A double-blind, randomised, placebo-controlled Trial - AMOXI

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004986-28-AT

Enrollment

Registered

2019-02-08

Start date

2019-03-25

Completion date

Unknown

Last updated

2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical extraction of third molars MedDRA version: 20.0 Level: PT Classification code 10047991 Term: Wisdom teeth removal System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 20.0 Level: LLT Classification code 10038349 Term: Removal of wisdom teeth System Organ Class: 10042613 - Surgical and medical procedur

Interventions

Trade Name: Amoxilan 1000 mg-Tabletten Product Name: Amoxilan 1000 mg-Tabletten Pharmaceutical Form: Tablet INN or Proposed INN: AMOXICILLIN

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate whether the perioperative usage of antibiotics is effective in reducing postoperative complications, compared to placebo, in patients undergoing wisdom teeth removal. ;Secondary Objective: Experience of pain, swelling and bleeding ;Primary end point(s): Inflammatory complications (swelling, purulence, mouth opening restriction);Timepoint(s) of evaluation of this end point: 7 days post surgery	—

Measure

Time frame

Main Objective: To evaluate whether the perioperative usage of antibiotics is effective in reducing postoperative complications, compared to placebo, in patients undergoing wisdom teeth removal. ;Secondary Objective: Experience of pain, swelling and bleeding ;Primary end point(s): Inflammatory complications (swelling, purulence, mouth opening restriction);Timepoint(s) of evaluation of this end point: 7 days post surgery

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Secondary

Measure	Time frame
Secondary end point(s): Occurrence of pain, bleeding, swelling;Timepoint(s) of evaluation of this end point: 7 days post surgery	—

Countries

Austria

Contacts

Public ContactPrincipal Investigator

Prof PD DDr. Michael Payer

mi.payer@medunigraz.at0043316385 80659

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026