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Tranexamic acid (TXA) is an effective hemostatic agent used to reduce blood loss and the need for transfusion. It is a relatively safe drug with minimal significant side effects. The most commonly reported complications include nausea, diarrhea, and occasional orthostatic reactions. The increased risk of thromboembolic events associated with the drug is the most serious complication; however, this has not been reported in most clinical studies and remains uncertain. Based on experience from other types of surgeries, tranexamic acid appears to be safe for use without an increased risk of venous thrombosis. To mitigate systemic absorption and minimize undesirable side effects, TXA can be applied topically rather than intravenously, reducing the risk of venous thromboembolism.
Topical TXA irrigation has recently begun to be used intraoperatively. In a study conducted by Eftekharian et al., the application of intraoperative 1% TXA irrigation solution during bimaxillary orthognathic surgery was found to be significantly associated with a reduction in intraoperative blood loss compared to placebo. Additionally, the topical application of TXA to the maxillary sinus during endoscopic sinus surgery has been shown to reduce intraoperative blood loss. In the current literature, the use of tranexamic acid irrigation during tooth extraction under local anesthesia has not been reported. Our study aims to demonstrate the effectiveness of TXA irrigation during the extraction of bone-retained teeth and its effect on postoperative edema.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| saline irrigation group | In the double-blind, controlled, randomized study, only saline will be used as the irrigation solution in the control group patients. |
| |
| tranexamic acid Irrigation group | In the double-blind, controlled, randomized study, saline with tranexamic acid solution will be used as the irrigation solution in the study group patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid | Drug | in the study group, a combination of two ampules of Tranexamic acid solution mixed with saline will be used. Intraoperative bleeding, surgical field visibility, and postoperative edema will be monitored. |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative edema | Anatomical landmarks, including gonion (Go), ala nasi (AN), tragus (Tr), and lateral canthus (Ka), will be marked with methylene blue for measurement purposes. The distances between lateral canthus and gonion, tragus and commissure, and gonion and ala nasi will be measured preoperatively (just before the procedure begins) and on postoperative day 3, when maximum edema is expected, and the values will be recorded. | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| intraoperative bleeding | During the surgery, the total aspirate volume collected in the suction device will be recorded. By subtracting the amount of irrigation solution used, the amount of bleeding (in cc) will be calculated separately for the right and left sides and documented. | during the surgery time |
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Inclusion Criteria:
Exclusion Criteria:
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community sample
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Taha Pergel, Asist.Prof | Contact | +902124531850 | tahapergel_05@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bezmialem Vakıf Universty | Recruiting | Istanbul | Fatih | 34093 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D004487 | Edema |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| saline irrigation | Drug | In control group, saline will be used for irrigation.Intraoperative bleeding, surgical field visibility, and postoperative edema will be monitored. |
|
| intraoperative vision scale |
Intraoperatively, based on the evaluation of surgical bleeding and surgical comfort, the surgeon will be asked to rate the surgical field on a 5-point scale after irrigation. An average score will be calculated postoperatively to determine the surgical field evaluation score. Separate scoring will be performed for both the right and left sides. Scale:
|
| during the surgery |