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

Phase 1

• 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 procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Dentistry [E06]

• Registration Number: EUCTR2017-004986-28-AT
• Lead Sponsor: Medizinische Universität Graz, Klin. Abteilung für Orale Chirurgie und Kieferorthopädie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-08
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 59

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

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