Prophylactic antibiotics in orthognathic surgery: A comparative prospective randomized study among regimens of amoxicillin-clavulanate.
Phase 3
Recruiting
- Conditions
- Postoperative infection after orthognathic surgery.orthognathic surgery, antibiotic prophylaxis, surgical site infection
- Registration Number
- TCTR20240427012
- Lead Sponsor
- The Royal College of Dental Surgeons of Thailand
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria
1.Patients without underlying medical conditions who underwent a Le Fort I osteotomy and mandibular osteotomy for orthognathic surgery .
Exclusion Criteria
1.Patients underwent segmental procedures.
2.BMI <18.5 or > 30 kg/m2
3.Patient with a genetic syndrome
4.The patient who had marked underlying diseases impairing a healing process such as diabetes, osteoporosis, or renal diseases
5.Intraoperative complication: bad split, excessive blood loss with blood transfusion.
6.The patient who is allergic to penicillin.
7.The patient who cannot be available for protocol follow-up after surgery.
8.The patient who underwent distraction osteogenesis (DO) and surgically assisted rapid palatal expansion (SARPE).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of Surgical Site Infection 1 month Diagnostic criteria for surgical site infection in orthognathic surgery
- Secondary Outcome Measures
Name Time Method Thai Oral Health Impact Profile 14 (questionnaire) 1 month Patient reported outcome using a questionnaire interview