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Influence of Tranexamic Acid on recovery after third molar Surgery: a randomized clinical trial

The impact of Tranexamic Acid on the quality of the postoperative period of patients undergoing Third Molars Extraction Surgery: a clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-8yxdhdv
Enrollment
Unknown
Registered
2025-11-25
Start date
2023-06-03
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Edema

Interventions

The study will include 24 adult participants, of both sexes, aged between 18 and 40 years, undergoing surgical extraction of impacted lower third molars. This is a randomized, double-blind, controlled

Sponsors

Universidade de Pernambuco
Lead Sponsor
Universidade de Pernambuco
Collaborator

Eligibility

Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Patients of both sexes between the ages of 18 and 40. Patients undergoing surgery to protect third molars. Those who agree to participate in the study and sign the informed consent form. Those who do not have autoimmune syndromes or diseases. Patients who do not have previously reported psychiatric or psychological disorders. Patients who do not have heart disease, liver disease, rheumatological, diabetic or chronic kidney problems. Those who do not have underlying diseases that alter the patient's sensory perceptions. Those who do not have lesions or dermatological pathologies on the face, which may hinder the application of the tests proposed in this study

Exclusion criteria

Exclusion criteria: Those who present any neurosensory alteration in the postoperative period. Patients who will use controlled medication or who, due to drug interaction, have contraindication to the use of any of the therapies proposed in this study. Individuals who develop any postoperative infection at the surgical site. Patients who develop any allergy or adverse effect related to the medications used. Participants who present episodes of vomiting or any discomfort that has not been resolved with protective medication. Participants who, for any reason, voluntarily wish to withdraw from the study. Those who do not comply with or do not attend all stages of the research. Women who, during the study period, become pregnant or are breastfeeding

Design outcomes

Primary

MeasureTime frame
Expected Outcome 1: It was expected that patients who received tranexamic acid administration would show a significant improvement in postoperative recovery quality, with a reduction in pain, facial edema, and trismus on the 2nd and 4th postoperative days compared to the control group. The evaluation would be conducted using the Visual Analog Scale (VAS) for pain assessment, linear facial measurements for edema, and interincisal mouth opening measurements for trismus.;Observed Outcome 1: The results confirmed the beneficial effect of tranexamic acid, demonstrating a significant reduction in pain, edema, and trismus scores on postoperative days 2 and 4 when compared to the control group. In addition, patients in the experimental group showed a smaller variation in total body volume as assessed by bioimpedance, indicating less fluid loss and better overall recovery. By the seventh postoperative day, both treatments showed similar recovery patterns; however, the group treated with tranexamic acid exhibited greater comfort and earlier recovery.

Secondary

MeasureTime frame
Expected Outcome 2: It was expected to observe a lower incidence of intraoperative and postoperative bleeding, as well as a better subjective perception of comfort and quality of life reported by patients treated with tranexamic acid, as measured through a standardized questionnaire.;Observed Outcome 2: A significant reduction in intraoperative and postoperative bleeding was observed in the group treated with tranexamic acid compared to the control group, particularly within the first 24 hours after surgery. In addition, participants who received the medication reported greater comfort and a better perception of recovery, as documented in the standardized subjective evaluation questionnaires. Patients in the experimental group also required fewer dressing changes and reported less metallic or bloody taste in the oral cavity, indicating more effective hemostatic control and an overall better postoperative experience.

Countries

Brazil

Contacts

Public ContactBruno Mesquita

Universidade de Pernambuco

brunomesquitajpa@hotmail.com+55-81-31847661

Outcome results

None listed

Source: REBEC (via WHO ICTRP)