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Recruiting NCT06806241

Effects of Tranexamic Acid Irrigation on Impacted Third Molar Surgery

Observational Bleeding Tooth Extraction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tranexamic acid, saline irrigation.
Who it may be relevant to
Registry conditions: Bleeding, Tooth Extraction. Basic parameters: 14 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

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

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

Primary outcome measures

  • postoperative edema [Time frame: 3 days]
Secondary outcome measures (2)
  • intraoperative bleeding [Time frame: during the surgery time]
  • intraoperative vision scale [Time frame: during the surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Turkey (Türkiye) · 1 center
  • Bezmialem Vakıf Universty — Istanbul

Identifiers

NCT: NCT06806241 · E.142551

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗