Postoperative bleeding after wisdom tooth extraction.
Conditions
Interventions
experimental group:(1) After the tooth extraction surgery, conduct routine treatment and fill the alveolar socket with the medical collagen sponge of appropriate specifications by using the test instr
control group:(1) After the tooth extraction surgery, conduct routine treatment and fill the alveolar socket with the medical collagen sponge of appropriate specifications by using the control instrum
Sponsors
The Affiliated Stomatological Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Those who need to undergo wisdom tooth extraction according to clinical evaluation; (2) Male or female patients aged between 18 and 65 years old; (3) Those who voluntarily participate in this trial and sign the informed consent form. The process of informed consent complies with relevant regulations.
Exclusion criteria
Exclusion criteria: (1) Those with contraindications for tooth extraction. (2) Those who have to extract >=2 teeth during one visit. (3) Those with acute infection in adjacent teeth or the surgical area; or those with a history of acute pericoronitis and apical infection within one month. (4) Those with severe primary diseases such as cardiovascular and cerebrovascular diseases, liver, kidney and hematopoietic system diseases, psychiatric patients, and poorly controlled diabetic patients (fasting blood glucose > 8mmol/L, 2-hour postprandial blood glucose > 10 mmol/L, glycosylated hemoglobin A1c > 7%), and hypertensive patients (blood pressure >= 140/90mmHg). (5) Patients whose religious beliefs prevent them from accepting the source of materials of the test instruments (collagen protein isolated and purified from bovine tissue or collagen protein extracted from domestic healthy beef tendon). (6) Patients whose liver and kidney function indexes, ALT and AST, exceed 1.5 times the upper limit of the normal reference range; or patients whose creatinine exceeds 1.2 times the upper limit of the normal reference range. (7) Patients with severe bleeding tendency (PT-INR > 1.5); or patients who have used drugs affecting blood coagulation function within one month. (8) Pregnant or lactating women, or patients who plan to get pregnant within 4 months. (9) Patients with allergic constitution, or those who are allergic to multiple drugs and foods, or those who are known to be allergic to the test instruments or their components. (10) Patients suspected of or confirmed to have a history of alcohol or drug abuse. (11) Patients who participated in other clinical trials within the recent one month. (12) Patients who, in the opinion of the researcher, have factors not suitable for participating in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effective rate of hemostasis 30 minutes after tooth extraction.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Wound healing rate ;Subject satisfaction: Pain, foreign body sensation; | — |
Countries
China
Contacts
Public ContactHuang Xuanping
Affiliated Stomatological Hospital of Guangxi Medical University
Outcome results
None listed