Antibiotic Prophylaxis Versus Placebo in Alveolar Bone Grafting: A Randomized Controlled Trial (NCT07296302) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Antibiotic Prophylaxis Versus Placebo in Alveolar Bone Grafting: A Randomized Controlled Trial
Brazil150 participantsStarted 2026-02
Plain-language summary
Tooth extraction sites often require alveolar bone grafting to preserve ridge dimensions and improve conditions for future implant placement. Although systemic antibiotic prophylaxis is commonly prescribed after grafting procedures, there is limited evidence supporting its necessity in healthy patients undergoing intraoral bone grafting. This randomized, double-blind, placebo-controlled clinical trial aims to compare the effects of prophylactic amoxicillin versus placebo on postoperative outcomes in alveolar bone graft procedures using Plenum® Oss HP biomaterial, a synthetic biphasic bioceramic composed of hydroxyapatite and beta-tricalcium phosphate (HA/β-TCP; 70:30 ratio).
Participants will be randomly assigned to receive either amoxicillin 500 mg every 8 hours for 7 days or a matching placebo. Clinical parameters, postoperative complications, and patient-reported outcomes will be assessed. The study seeks to determine whether antibiotic prophylaxis provides measurable clinical benefits or whether placebo yields comparable results, contributing to more rational antibiotic use and supporting antimicrobial stewardship in oral surgery.
Who can participate
Age range
18 Years – 65 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:
* Age between 18 and 65 years.
Generally healthy individuals classified as American Society of Anesthesiologists (ASA) physical status I or II ( ASA I or ASA II).
Indication for tooth extraction followed by alveolar bone grafting in a fresh socket.
Absence of active infection at the surgical site.
Willingness to take amoxicillin or, in cases of β-lactam antibiotic allergy, azithromycin.
No use of antibiotics in the previous 30 days.
Agreement to participate and signature of the informed consent form (ICF).
Exclusion Criteria:
* Presence of uncontrolled systemic diseases or chronic use of immunosuppressive medications.
Pregnancy or breastfeeding.
Severe liver disease.
Smoking more than 10 cigarettes per day.
Known allergy to macrolides (azithromycin).
Prior use of antibiotics within the last 30 days.
Concomitant use of medications with known risk of QT interval prolongation.
Signs of acute infection at the extraction site.
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.
1Since this trial is not yet recruiting, how long do you think it might be before it opens, and would it make sense for me to wait for it or proceed with my alveolar bone grafting now?
2This study is testing whether a placebo — meaning no antibiotic — is just as safe as antibiotic prophylaxis after bone grafting surgery, so if I'm assigned to the placebo group, what does that actually mean for my infection risk during recovery?
3Postoperative infection is what this trial is specifically measuring — how common is that complication with current standard care, and how would being in this study change how closely I'd be monitored for it?
4Since this trial is listed as Phase NA, which can mean it's a practical or procedural study rather than an early drug safety test, can you help me understand what stage of evidence we're at on whether antibiotics after bone grafting are actually necessary?
5Are there factors in my personal health history — like my immune system, the complexity of my planned graft, or any medications I take — that would make the placebo arm of this study a bigger concern for me specifically?
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.