The effect of prophylactic antibiotics on post-extraction symptoms in healthy subjects

JRCT ID: jRCTs061240095

Registered date:24/12/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients who have had bilateral premolar extractions due to orthodontic treatment
• Date of first enrollment: 24/12/2024
• Target sample size: 40
• Study type: Interventional
• Intervention(s): The study drug is amoxicillin capsule 250mg taken before the convenient tooth extraction. Placebo is used as the control drug. The subjects will be randomly assigned to take amoxicillin either in the first or second dose of the two convenient tooth extractions.

Outcome(s)

• Primary Outcome: Incidence of postoperative pain from the day of tooth extraction to 7 days (up to 6 days after tooth extraction)

Secondary Outcome

1) The degree of postoperative pain from the day of extraction to 7 days (up to 6 days after extraction), and whether or not painkillers were taken and the number of times they were taken
2) The presence or absence and degree of swelling inside and outside the mouth after extraction (within 7-11 days)
3) The presence or absence, condition, and response of incomplete healing of the extraction socket after extraction (within 7-11 days)
4) The presence or absence of abnormal events related to the extraction socket after extraction (within 30-50 days)

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: < 50age old
• Gender: Both

Include criteria

1 more than 16 years to less than 50 years old at the time of consent
2 Convenient extraction of the first and second premolars on both the upper and lower jaws
3 Written consent is obtained from the subjects and/or legal representative (if a minor) regarding participation in this study.

Exclude criteria

1 Those with acute oral inflammation at the time of registration
2 Those with penicillin allergies
3 Those with loxoprofen allergies
4 Those with diabetes
5 Those with heart disease
6 Those with cerebral infarction or neurological disease
7 Those with a history of trauma or surgery in the head and neck area
8 Those with immune disorders receiving treatment with immunosuppressants such as steroids
9 Those who are pregnant or may be pregnant
10Those who are breastfeeding
11Those who are deemed inappropriate by the principal investigator or co-investigator

Related Information

• Primary Sponsor: Kouji Ohta