Effect of Systemic Antibiotic Therapy on Postoperative Complications in Patients Undergoing Wisdom Teeth Removal Surgery.

Study Overview
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Brief Summary
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59 medically healthy patients, who are scheduled for third molar extraction surgery and give informed consent for the trial, are operated using a split-mouth technique. One group of patients will be assigned to the test group (Amoxilan) for the first surgery and to the control group (placebo) for the second surgery, and vice versa, according to randomisation. Patients receive 8 capsules Amoxilan or placebo (according to randomisation) perioperatively, and 6 capsules Amoxilan/placebo per day for 3 days postoperativeley.

Official Title
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Effect of Systemic Antibiotic Therapy on Postoperative Complications in Patients Undergoing Wisdom Teeth Removal Surgery. A Double-blind, Randomised, Placebo-controlled Trial

Conditions
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Third Molar Extraction Surgery

Intervention / Treatment
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* Drug: Amoxilan
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptom-free, bilaterally located third molars Medically healthy patient ≥ 16 years No allergies/intolerances against the investigational product/placebo Informed consent Exclusion Criteria: General contraindications to wisdom tooth extraction surgery (Former) heavy smoking Use of antibiotics within the last three months or patients requiring antibiotic treatment prior to surgery (Planned) Pregnancy/lactating

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amoxilan<br>Patients receive 8 capsules Amoxilan perioperatively and for the next 3 days 6 capsules per day. | Drug: Amoxilan<br>* Patients receive 8 capsules Amoxilan perioperatively and for the next 3 days 6 capsules per day<br>|
| Placebo Comparator: Placebo<br>Patients receive 8 capsules Placebo perioperatively and for the next 3 days 6 capsules per day. | Other: Placebo<br>* Patients receive 8 capsules placebo perioperatively and for the next 3 days 6 capsules per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mouth opening restrictions: Change of interincisal distance | Interincisal distance, with maximum mouth opening, is measured with a ruler. | preoperatively as well as on the 1st and 7th postoperative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of swelling | Swelling in the cheek area will be determined using a tape measure and 3D photographs. | preoperatively as well as on the 1st and 7th postoperative day | 
| Change of Visual Analogue Scale (VAS): Bleeding | Patients indicate bleeding symptoms on a VAS scale, ranging from 0-10, whereas higher values indicate a worse outcome | day of surgery, and on day 1, 2, 3, 4, 5, 6, 7 after surgery | 
| Change of Visual Analogue Scale (VAS): Swelling | Patients indicate swelling on a VAS scale, ranging from 0-10, whereas higher values indicate a worse outcome | day of surgery, and on day 1, 2, 3, 4, 5, 6, 7 after surgery | 
| Change of Visual Analogue Scale (VAS): Pain | Patients indicate pain on a VAS scale, ranging from 0-10, whereas higher values indicate a worse outcome | day of surgery, and on day 1, 2, 3, 4, 5, 6, 7 after surgery |