Effects of Tranexamic Acid Irrigation on Impacted Third Molar Surgery

NCT06806241 | Recruiting

• 1 other identifier: E.142551
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Bleeding; Tooth Extraction

Keywords

bleeding; tranexamic acid; wisdom teeth removal; edema

Outcome Measures

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.

  3 days

Secondary Outcomes (2)

• intraoperative bleeding

  during the surgery time

• intraoperative vision scale

  during the surgery

Study Arms (2)

saline irrigation group

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

Drug: saline irrigation

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.

Drug: Tranexamic acid

Interventions

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.

tranexamic acid Irrigation group

saline irrigation DRUG

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

saline irrigation group

Eligibility Criteria

• Age: 14 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

community sample

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakıf Universty

Istanbul, Fatih, 34093, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Hemorrhage; Edema

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Central Study Contacts

Taha Pergel, Asist.Prof

CONTACT

+902124531850; tahapergel_05@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 4, 2025
• Study Start: January 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 10, 2026
• Last Updated: June 24, 2025

Record last verified: 2025-06

Locations

TU (1)