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Effects of Tranexamic Acid Irrigation on Impacted Third Molar Surgery

Investigation of the Effects of Tranexamic Acid Solution Irrigation on Bleeding, Surgical Field Visibility, and Postoperative Edema in the Extraction of Horizontally Impacted Third Molars

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06806241
Enrollment
20
Registered
2025-02-04
Start date
2025-01-01
Completion date
2026-03-10
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleeding, Tooth Extraction

Keywords

bleeding, tranexamic acid, wisdom teeth removal, edema

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.

Interventions

DRUGTranexamic acid

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.

In control group, saline will be used for irrigation.Intraoperative bleeding, surgical field visibility, and postoperative edema will be monitored.

Sponsors

Bezmialem Vakif University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
14 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
postoperative edema3 daysAnatomical 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

MeasureTime frameDescription
intraoperative bleedingduring the surgery timeDuring 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 scaleduring the surgeryIntraoperatively, 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactTaha Pergel, Asist.Prof
tahapergel_05@hotmail.com+902124531850

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026