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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amoxilan | Experimental | Patients receive 8 capsules Amoxilan perioperatively and for the next 3 days 6 capsules per day. |
|
| Placebo | Placebo Comparator | Patients receive 8 capsules Placebo perioperatively and for the next 3 days 6 capsules per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amoxilan | Drug | Patients receive 8 capsules Amoxilan perioperatively and for the next 3 days 6 capsules per day |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universität Graz, Klin. Abteilung für Orale Chirurgie und Kieferorthopädie | Graz | 8010 | Austria |
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| Placebo | Other | Patients receive 8 capsules placebo perioperatively and for the next 3 days 6 capsules per day |
|
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 |