Ongoing Clinical Trials for Gingival Bleeding
Currently, there is 1 ongoing clinical trial investigating treatment options for preventing excessive bleeding during dental procedures. This trial focuses on patients taking blood-thinning medications who require tooth extraction, testing whether Tranexamic Acid Oral Solution can safely reduce bleeding complications.
Clinical trial locations
- Croatia
- Hungary
- Romania
- Spain
Study on Tranexamic Acid Oral Solution for Preventing Bleeding in Patients on Blood Thinners Undergoing Tooth Extraction
This clinical trial is investigating whether Tranexamic Acid Oral Solution 5% can help prevent excessive bleeding in patients who take blood-thinning medications and need to have one or more teeth removed. The blood thinners involved include direct oral anticoagulants and vitamin K antagonists, which help prevent blood clots but can increase the risk of bleeding during and after dental procedures.
Main inclusion criteria: Participants must be 18 years or older and have been taking blood-thinning medications regularly for at least 3 months. They must be scheduled for tooth extraction and have adequate hemoglobin levels (at least 12.0 g/dL for males or 11.0 g/dL for females). For patients taking vitamin K antagonists, their INR (a blood clotting test) should be between 2.0 and 3.5. Participants need a body mass index between 18.5 and 35, weigh at least 50 kg, and have a platelet count between 100,000 and 500,000 per microliter. Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control. Participants must be willing to avoid alcohol during the study and follow all study requirements.
Main exclusion criteria: Patients who are not taking direct oral anticoagulants or vitamin K antagonists cannot participate. Those not undergoing tooth extraction, not at risk of clinically significant bleeding, or not within the specified age range are excluded. The study also excludes patients considered part of vulnerable populations or those not meeting the specific clinical trial group criteria.
Focus and goal: This is a double-blind study, meaning neither participants nor researchers know who receives the actual medication or placebo. The main goal is to determine if Tranexamic Acid Oral Solution 5% can effectively reduce clinically significant bleeding in the mouth and facial area after tooth extraction. The study monitors bleeding episodes during and after the dental procedure, lasting up to seven days of treatment. Researchers will also assess how acceptable the medication is to participants, including how easy it is to take as directed.
Investigational drug: Tranexamic Acid Oral Solution 5% is the medication being tested. It works as an antifibrinolytic agent, which helps prevent excessive bleeding by stabilizing blood clots and inhibiting their breakdown. The solution is taken by mouth in liquid form and aims to help the blood clot more effectively in patients prone to bleeding due to their blood-thinning medications.
Summary
Currently, only one clinical trial is actively investigating prevention of bleeding complications during dental procedures for patients on anticoagulant therapy. This phase 3 trial is being conducted across four European countries: Croatia, Hungary, Romania, and Spain. The study focuses specifically on Tranexamic Acid Oral Solution 5% as a potential preventive treatment for postoperative oral bleeding in patients undergoing tooth extraction while taking blood thinners. This represents an important area of research, as patients on anticoagulant medications face increased bleeding risks during dental procedures, and effective preventive options could significantly improve safety and outcomes for this patient population.