Effect of antibiotics on complications after dental implant surgery
The Effect of Systemic Antibiotics on Post-surgical Complications and Patient-centered Outcomes in Patients Undergoing Implant Surgery With Guided Bone Regeneration and Simultaneous Sinus Floor Elevation
This study tests whether taking antibiotics before dental implant surgery can help healthy adults avoid complications after the procedure.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Medical University of Graz Academic / other |
| Locations | 1 site (Graz) |
| Trial ID | NCT04552080 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the impact of systemic antibiotics, specifically Amoxicillin, compared to a placebo in patients undergoing oral implant therapy that includes guided bone regeneration and sinus floor elevation. The primary focus is on patient-centered outcomes and the incidence of post-surgical complications. The study includes medically healthy adults aged 21 and older who are non-smokers or light smokers and have specific dental conditions requiring implants. The trial aims to provide insights into the effectiveness of antibiotics in improving surgical outcomes in dental procedures.
Who should consider this trial
Good fit: Ideal candidates are medically healthy adults aged 21 and older with specific dental conditions requiring sinus floor elevation and implant placement.
Not a fit: Patients with significant medical conditions or contraindications to implant treatment will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved post-surgical outcomes and reduced complications for patients undergoing dental implant procedures.
How similar studies have performed: Previous studies have shown varying results regarding the use of antibiotics in dental implant procedures, making this approach both relevant and necessary for further exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Medically healthy adult: ASA (American Society of Anesthesiologists) classification I-II, age ≥ 21 years old 2. Non-smoker, previous smoker (quit ≥ 5 years); light smoker with less than 10 cigarettes/ day 3. Not allergic to Amoxicillin/Penicillin antibiotics, NSAIDS (Nonsteroidal anti-inflammatory drugs) or corn-starch 4. Edentulous spaces in the posterior maxilla in one or 2 posterior quadrants with an alveolar bone defect requiring sinus floor elevation and allowing implant placement of up to 3 dental implants and simultaneous GBR (residual crest height 3-5 mm; per implant site (Felice et al. 2012; Park et al. 2019). 5. Absence of signs of pathology of the sinus membrane and acute sinusitis requiring ongoing management - Exclusion Criteria: 1. Medically compromised subjects (ASA classification III-V) 2. General contraindications against implant treatment or augmentative procedures (e.g. immunodeficiency, advanced systemic diseases, corticosteroid medication) 3. Those taking Bisphosphonates/anti-angiogenic/RANKL (Receptor activator of nuclear factor kappa-Β Ligand) inhibitor medications or receiving local radio-therapy 4. Heavy smoker or previous heavy smoker (quit \< 5 years; ≥ 10 cigarettes/day) 5. Allergic to Amoxicillin or Penicillin antibiotics, NSAIDS and / or corn starch 6. Use of any form of antibiotics in the last 3 months or subjects requiring regular antibiotic prophylaxis prior to dental treatment 7. Pregnant or breast feeding. Self-declared intend to conceive (A pregnancy test will be performed for all female patients). 8. Need for 2 stage sinus augmentation 9. Acute or unmanaged symptomatic sinusitis 10. Type 1 implant placement (immediate implant placement following extraction) 11. Need for simultaneous soft tissue augmentation 12. Residual bone height of \> 5mm. 13. Subjects aged \< 21 years old
Where this trial is running
Graz
- Medical University of Graz, University Hospital for Dentistry and Oral Health — Graz, Austria (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.