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NCT Number: NCT06806241

Effects of Tranexamic Acid Irrigation on Impacted Third Molar Surgery

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.

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Key information

Conditions

Bleeding Edema Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Tooth Extraction

Age range

14 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bezmialem Vakıf Universty

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location status: Recruiting

Location contact

taha pergel, DDS

CONTACT

[email protected]

+902124531850

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. postoperative edema

    Time frame: 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 outcomes

  1. intraoperative bleeding

    Time frame: 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.

  2. intraoperative vision scale

    Time frame: 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:

    • - Intense bleeding, making it impossible to isolate the tooth.
    • - Severe bleeding, making isolation difficult.
    • - Moderate bleeding, causing slight difficulty in isolation.
    • - Mild bleeding, isolation is unaffected.
    • - No bleeding or an almost bloodless surgical field.

Study contacts

Contact information is provided by the study sponsor or research team.

Taha Pergel, Asist.Prof

CONTACT

[email protected]

+902124531850

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 4, 2025
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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