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

NCT07296302 | Not Yet Recruiting

• 1 other identifier: ARSJ-RCT-ABXGRAFT-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alveolar Ridge Augmentation; Bone Grafting; Antibiotic Prophylaxis

Keywords

Ridge Preservation; Alveolar Bone Graft; Antibiotic Prophylaxis; Synthetic Bone Graft; Biphasic Calcium Phosphate

Outcome Measures

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.

  7, 14, and 30 days post-procedure

Secondary Outcomes (4)

• Volumetric bone formation and mineral density assessed by CBCT

  Baseline and 6 months

• Histomorphometric characteristics of regenerated bone

  6 months

• Bacterial load at grafted sites

  7 and 14 days

• Proteomic and metabolomic profile of regenerated bone tissue

  6 months

Study Arms (2)

Amoxicillin Prophylaxis Group

ACTIVE COMPARATOR

Amoxicillin 500 mg 1 hour before surgery, followed by 500 mg every 8 hours for 7 days. In case of penicillin allergy, azithromycin 500 mg 1 hour before surgery followed by 500 mg once daily for 3 days.

Drug: Amoxicillin 500 mg (prophylactic regimen)

Placebo Group

PLACEBO COMPARATOR

Placebo capsules identical in appearance to the active medication. Dosing schedule matches the amoxicillin regimen: one capsule administered 1 hour preoperatively, followed by capsules every 8 hours for 7 days. For participants with documented penicillin allergy, placebo capsules will follow the azithromycin schedule (one dose preoperatively and one capsule daily for 3 days).

Drug: Placebo Capsule (matched dosing schedule)

Interventions

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.

Amoxicillin Prophylaxis Group

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).

Placebo Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Agnaldo Rocha de Souza Junior: lead

Study Sites (1)

Universidade Estadual de Montes Claros - Unimontes

Montes Claros, Minas Gerais, 39401-8321, Brazil

Location

MeSH Terms

Interventions

Amoxicillin

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Agnaldo Rocha de Souza Junior, DDS, MSc, PhD

CONTACT

+55 (38) 984133929; agnaldo.junior@unimontes.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, care providers, investigators, and outcomes assessors will remain blinded to group allocation. Amoxicillin and placebo capsules are identical in appearance, packaging, and administration schedule. Randomization codes will be held by an independent researcher and will only be revealed after completion of all data collection and primary analyses.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator, DDS, MSc, PhD

Model Details: Participants will be randomly assigned to one of two parallel groups: an amoxicillin group receiving 500 mg every 8 hours for 7 days and a placebo group receiving identical capsules. Both groups will undergo the same surgical protocol for alveolar bone grafting and will be followed at identical time points for clinical, radiographic, microbiological, and molecular assessments.

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 22, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)