"Is Antibiotic Therapy Necessary for Patients Undergoing Extraction of Teeth With Abscess?" (NCT07694531) | Clinical Trial Compass
CompletedNot Applicable
"Is Antibiotic Therapy Necessary for Patients Undergoing Extraction of Teeth With Abscess?"
India176 participantsStarted 2025-03-20
Plain-language summary
This is a triple-blind randomized controlled trial conducted at the Department of Oral and Maxillofacial Surgery, Subbaiah Institute of Dental Sciences, Shimoga. The study enrolls 176 adult patients aged above 18 years belonging to ASA class 1 or 2, requiring intra-alveolar extraction of non-restorable carious teeth with radiographic evidence of periapical abscess of less than 1.5 cm in diameter. Patients are randomly allocated into two equal groups of 88 each. Group A receives postoperative Amoxicillin 500 mg thrice daily for 5 days in addition to standard analgesics. Group B receives only standard analgesics with no antibiotic prescription. The primary outcome measure is wound healing assessed on postoperative day 5 using a modified Landry Wound Healing Index evaluating gingival tissue color, response to palpation, presence of granulation tissue, and suppuration.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients aged above 18 years
* Patients who are willing to participate in the study
* Patients requiring extraction of non-restorable carious teeth with radiographic evidence of periapical abscess (\< 1.5cm diameter ill-defined, diffused periapical radiolucent lesion )
* Patients who come under ASA class 1 and 2 classification
Exclusion Criteria:
* Patients requiring trans-alveolar extraction
* Patients with known Penicillin allergy
* Pregnant women
* Patients undergoing antibiotic therapy perioperatively
* Patients not complying with follow-up
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessment of the extraction socket healing of both the groups using a modified Landry's Wound Healing Index