NCT06502288

Evaluation of Antibiotic Administration Following Tooth Extraction

Evaluation of Necessity of Antibiotic Administration Following Tooth Extraction: A Randomized Control Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: Chittagong Medical College · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The trial aims to evaluate the effects of prescribing antibiotics after tooth extraction. 152 dental patients aged 18 to 50 will be randomly assigned. The study will assess infection rates, healing times, pain, and adverse effects in patients who receive antibiotics versus those who do not. The trial will be conducted at the Oral and Maxillofacial Surgery Department, Dental Unit, Chittagong Medical College. Data analysis will involve the use of the χ²-test, t-tests, and logistic regression, with a significance level of 5%. Ethical considerations include obtaining informed consent from all participants, and safety will be monitored by an independent expert team.

Detailed description

Antibiotics are commonly prescribed in dentistry as a prophylactic measure, particularly following tooth extraction which are overused and misused in dental practice, leading to a rise in antimicrobial resistance. By randomly assigning 152 dental patients aged between 18 to 50 years, this trial aims to evaluate the outcomes such as infection rates, healing times, pain and adverse effects of patients receiving antibiotics after tooth extraction versus those who do not. The study will be conducted at the Oral and Maxillofacial Surgery Department, Dental Unit, Chittagong Medical College. Tooth extractions will be performed under aseptic conditions, followed by standard post-operative care. The intervention group will receive 625 mg amoxicillin with clavulanic acid three times daily for 7 days post-extraction, while the control group will not receive any antibiotic. Both groups will receive 400 mg ibuprofen and 20 mg omeprazole twice daily. Surgeons, patients and assessors will be blinded to group assignments, with a third party managing medication distribution. Clinical evaluations will occur on the 3rd, 7th, and 14th days post-extraction. The Landry wound healing index will be used to assess tissue healing and pain will be recorded using a visual analogue scale. Surgical Site Infection will be diagnosed based on specific clinical criteria. Any Adverse reactions will be monitored. Rescue Additional analgesia and antibiotics will be provided as needed. Data analysis will be done using the χ²-test, t-tests and logistic regression, with a significance level of 5%. Ethical considerations include obtaining informed consent from all participants. An independent expert team will conduct safety monitoring to manage any adverse events. The results of this study could provide valuable insights for future clinical protocols in dental surgery and contribute to the broader public health goal of reducing unnecessary antibiotic use.

Conditions

• Tooth Extraction

Interventions

Type	Name	Description
DRUG	625 mg of amoxicillin with combined clavulanic acid tablet	The intervention group must take 625 mg of amoxicillin with combined clavulanic acid tablets three times a day after meals for 7 days following extraction.

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-08-30
• Completion: 2025-10-15
• First posted: 2024-07-16
• Last updated: 2024-07-16

Locations

1 site across 1 country: Bangladesh