Evaluation of the Effects of Local Application of Tranexamic Acid Combined With Leukocyte- and Platelet-Rich Fibrin on Hemostasis and Wound Healing After Tooth Extraction in Patients Receiving Direct Oral Anticoagulants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Soft tissue wound healing assessed using the Landry Wound Healing Index
研究概览
简要总结
This randomized split-mouth clinical study evaluated the effects of tranexamic acid-modified leukocyte- and platelet-rich fibrin (L-PRF) on hemostasis, postoperative pain, and soft-tissue wound healing after tooth extraction in patients receiving direct oral anticoagulants (DOACs). In each participant, extraction sites were allocated to either tranexamic acid-modified L-PRF or an absorbable gelatin sponge as a local hemostatic intervention. Hemostasis was assessed 30 minutes after extraction, postoperative pain was evaluated at 24, 48, and 72 hours, and soft-tissue wound healing was assessed on days 7, 14, and 21.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessments were performed by a blinded evaluator.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Receiving treatment with one of the specified direct oral anticoagulants (DOACs) for at least 2 months
- •No known hypersensitivity to the study materials
- •No diagnosis of malignant or premalignant lesions
- •Indication for extraction of at least two non-adjacent teeth
排除标准
- •Refusal to participate or inability/unwillingness to provide written informed consent
- •History of hypersensitivity or allergy to local anesthetics
- •Immunosuppression
- •Acute infection in any tooth planned for extraction
- •Treatment with antiresorptive medications
- •Essential or congenital coagulation disorders
- •Severe cirrhosis
- •Chronic kidney disease
- •Uncompensated diabetes mellitus
- •Uncontrolled hypertension
- •Pregnancy or breastfeeding
研究组 & 干预措施
TXA-Modified L-PRF
Participants received tranexamic acid-modified leukocyte- and platelet-rich fibrin (L-PRF) in the randomly allocated extraction socket as the local hemostatic intervention.
干预措施: Tranexamic Acid-Modified L-PRF (Other)
Absorbable Gelatin Sponge
Participants received an absorbable gelatin sponge in the randomly allocated extraction socket as the local hemostatic intervention.
干预措施: Absorbable Gelatin Sponge (Other)
结局指标
主要结局
Soft tissue wound healing assessed using the Landry Wound Healing Index
时间窗: 7, 14, and 21 days after tooth extraction
Soft tissue wound healing was assessed by a blinded examiner using the Landry Wound Healing Index. The index evaluates tissue color, suppuration, bleeding, granulation tissue, and connective tissue exposure. Healing was scored on a 1-5 scale: 1 = very poor, 2 = poor, 3 = good, 4 = very good, and 5 = excellent healing. Higher scores indicate better soft tissue healing.
次要结局
- Postoperative hemostasis at 30 minutes(30 minutes after placement of the final suture)
- Postoperative pain assessed using the Visual Analog Scale(24, 48, and 72 hours after tooth extraction)
- Postoperative analgesic consumption(24, 48, and 72 hours after tooth extraction)
研究者
Merve Yiğit
Research Assistant
Cumhuriyet University