Effects of Tranexamic Acid Irrigation on Impacted Third Molar Surgery

Recruiting

• Conditions: Bleeding; Tooth Extraction
• Interventions: Drug: saline irrigation; Drug: Tranexamic acid

• Registration Number: NCT06806241
• Lead Sponsor: Bezmialem Vakif University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-01
• Study First Submitted: 2025-01-27
• Study First Submitted QC: 2025-01-31
• Last Update Submitted: 2025-01-31
• Study First Posted: 2025-02-04
• Last Update Posted: 2025-02-04
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Indicated for the Extraction of Bilaterally Impacted Third Molars with Bone Retention.
2. Systemically healthy patients aged 14-40 years with no bleeding disorders.

Exclusion Criteria

1. Patients with systemic diseases affecting general health.
2. Patients diagnosed with any bleeding disorder.
3. Patients with advanced infection or cysts associated with the impacted tooth.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
saline irrigation group	saline irrigation	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	Tranexamic acid	In the double-blind, controlled, randomized study, saline with tranexamic acid solution will be used as the irrigation solution in the study group patients.

Primary Outcome Measures

Name	Time	Method
postoperative edema	3 days	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.

Secondary Outcome Measures

Name	Time	Method
intraoperative bleeding	during the surgery time	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.
intraoperative vision scale	during the surgery	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: 1. - Intense bleeding, making it impossible to isolate the tooth.; 2. - Severe bleeding, making isolation difficult.; 3. - Moderate bleeding, causing slight difficulty in isolation.; 4. - Mild bleeding, isolation is unaffected.; 5. - No bleeding or an almost bloodless surgical field.

Trial Locations

Locations (1)

Bezmialem Vakıf Universty; 🇹🇷 Istanbul, Fatih, Turkey