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Antibiotic Prophylaxis Versus Placebo in Alveolar Bone Grafting: A Randomized Controlled Trial

ConditionsAlveolar Ridge AugmentationBone GraftingAntibiotic Prophylaxis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAgnaldo Rocha de Souza Junior

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age between 18 and 65 years.

Disqualifiers

Presence of uncontrolled systemic diseases or chronic use of immunosuppressive medications.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Amoxicillin 500 mg (prophylactic regimen)

    Drug

    Amoxicillin 500 mg administered 1 hour before surgery, followed by 500 mg every 8 hours for 7 days. Participants with documented penicillin allergy will receive azithromycin 500 mg 1 hour before surgery, followed by 500 mg once daily for 3 days.

  • Placebo Capsule (matched dosing schedule)

    Drug

    Participants will receive placebo capsules identical in appearance to the active medication, containing no active drug. One placebo capsule will be administered 1 hour before surgery, followed by placebo capsules every 8 hours for 7 days, matching the amoxicillin dosing schedule. Participants with documented penicillin allergy randomized to the placebo group will receive placebo capsules matching the azithromycin schedule (one dose preoperatively and one capsule daily for 3 days).

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Amoxicillin Prophylaxis GroupActive comparator 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of postoperative infection

Incidence of postoperative infection at 7, 14, and 30 days after alveolar bone grafting, assessed through clinical parameters including local pain, edema, purulent discharge, erythema, wound dehiscence, fever, and need for additional antibiotic therapy. Diagnosis will follow predefined clinical criteria.

Time frame
7, 14, and 30 days post-procedure

Secondary outcomes

1

Volumetric bone formation and mineral density assessed by CBCT

Volumetric bone gain and mineral density will be evaluated using cone-beam computed tomography (CBCT) scans performed at baseline and 6 months post-grafting. Standardized 3D segmentation will be applied to quantify bone formation and density changes within the grafted area.

Time frame
Baseline and 6 months
2

Histomorphometric characteristics of regenerated bone

Histomorphometric assessment of bone biopsies collected at implant site reopening. Parameters include percentage of vital bone, residual graft particles, connective tissue, and inflammatory infiltrate.

Time frame
6 months
3

Bacterial load at grafted sites

Bacterial load will be quantified from paper point samples collected at postoperative days 7 and 14. Quantification will include total bacterial burden and specific pathogens associated with postoperative infections.

Time frame
7 and 14 days
4

Proteomic and metabolomic profile of regenerated bone tissue

Proteomic and metabolomic profiling will be performed on bone biopsy specimens to identify molecular pathways associated with healing, infection, inflammation, and graft integration.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Agnaldo Rocha de Souza Junior

Lead sponsor

Universidade Estadual de Montes Claros

Sponsor institution

Source ClinicalTrials.gov

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