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Effects of Tranexamic Acid Irrigation on Impacted Third Molar Surgery

ConditionsBleedingTooth Extraction
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14-40
SponsorBezmialem Vakif University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Indicated for the Extraction of Bilaterally Impacted Third Molars with Bone Retention.

Systemically healthy patients aged 14-40 years with no bleeding disorders.

Disqualifiers

Patients with systemic diseases affecting general health.

Patients diagnosed with any bleeding disorder.

Patients with advanced infection or cysts associated with the impacted tooth.

Trial population

community sample

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • 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.

  • saline irrigation

    Drug

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

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: saline irrigation group1 intervention
Group B: tranexamic acid Irrigation group1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
3 days

Secondary outcomes

1

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.

Time frame
during the surgery time
2

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: 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.

Time frame
during the surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bezmialem Vakif University

Lead sponsor

Source ClinicalTrials.gov
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