Prophylactic antibiotics in orthognathic surgery: A comparative prospective randomized study among regimens of amoxicillin-clavulanate.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20240427012

Enrollment

Registered

2024-04-27

Start date

2023-09-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Postoperative infection after orthognathic surgery. orthognathic surgery, antibiotic prophylaxis, surgical site infection

Interventions

The participants will be given 2.4 g of intravenous amoxicillin-clavulanate 60 minutes pre-operatively and 1.2 g intravenous every 8 hours postoperatively for 24 hours. As following reference: Lohsir

103:99-105.,The participants will be given 2.4 gm of intravenous amoxicillin-clavulanate 60 minutes pre-operatively and 1.2 g intravenous every 8 hours postoperatively for 72 hours. As following refe

103:99-105.,The participants will be given 1.2 gm of intravenous amoxicillin-clavulanate 60 minutes pre-operatively and 1.2 g intravenous every 8 hours postoperatively for 72 hours, followed by Amoxic

Experimental Drug,Experimental Drug,Experimental Drug

Group1: Postoperative IV ATB 24 hours,Group2: Postoperative IV ATB 72 hours,Group3: Postoperative IV ATB 72 hours and oral ATB 4 days

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients without underlying medical conditions who underwent a Le Fort I osteotomy and mandibular osteotomy for orthognathic surgery .

Exclusion criteria

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).

Design outcomes

Primary

Measure	Time frame
Incidence of Surgical Site Infection 1 month Diagnostic criteria for surgical site infection in orthognathic surgery	—

Secondary

Measure	Time frame
Thai Oral Health Impact Profile 14 (questionnaire) 1 month Patient reported outcome using a questionnaire interview	—

Countries

Thailand

Contacts

Public ContactPakaphol Terakulvanich

Faculty of dentistry, Chulalongkorn university

pakaphol_moo@hotmail.com0852148291

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026