Effects of Tranexamic Acid Irrigation on Impacted Third Molar Surgery

NCT ID: NCT06806241

Last Updated: 2025-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-03-10

Brief Summary

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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

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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.

Conditions

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Bleeding Tooth Extraction

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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saline irrigation group

In the double-blind, controlled, randomized study, only saline will be used as the irrigation solution in the control group patients.

saline irrigation

Intervention Type DRUG

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

tranexamic acid Irrigation group

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

Tranexamic acid

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

saline irrigation

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

14 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bezmialem Vakif University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bezmialem Vakıf Universty

Istanbul, Fatih, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Taha Pergel, Asist.Prof

Role: CONTACT

+902124531850

Facility Contacts

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taha pergel, DDS

Role: primary

+902124531850

Other Identifiers

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E.142551

Identifier Type: -

Identifier Source: org_study_id

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