Actively Recruiting
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
Led by Medical University of Graz · Updated on 2024-07-03
30
Participants Needed
1
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary aim of the trial is to evaluate the effect of systemic antibiotic administration compared to placebo in patients undergoing oral implant therapy with simultaneous lateral sinus floor elevation and guided bone regeneration (GBR) in regard to patient-centered outcomes. The secondary aims of the trial is to evaluate the effect of systemic antibiotic administration on postsurgical complications, in patients undergoing oral implant therapy with simultaneous lateral approach sinus floor elevation and guided bone regeneration (GBR).
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Medically healthy adults classified as ASA I-II, aged 21 years or older
- Non-smokers, previous smokers who quit at least 5 years ago, or light smokers with fewer than 10 cigarettes per day
- No allergies to amoxicillin, penicillin antibiotics, NSAIDs, or corn starch
- Presence of edentulous spaces in the posterior maxilla needing sinus floor elevation and allowing placement of up to 3 dental implants with simultaneous guided bone regeneration
- No signs of sinus membrane pathology or acute sinusitis requiring ongoing care
You will not qualify if you...
- Medically compromised individuals classified as ASA III-V
- General contraindications to implant or augmentation procedures, including immunodeficiency, advanced systemic diseases, or corticosteroid use
- Current use of bisphosphonates, anti-angiogenic, or RANKL inhibitor medications, or receiving local radiotherapy
- Heavy smokers or those who quit less than 5 years ago, smoking 10 or more cigarettes per day
- Allergies to amoxicillin, penicillin antibiotics, NSAIDs, or corn starch
- Use of any antibiotics in the last 3 months or requiring regular antibiotic prophylaxis before dental treatment
- Pregnant or breastfeeding women or those intending to conceive
- Need for two-stage sinus augmentation
- Acute or unmanaged symptomatic sinusitis
- Immediate implant placement following extraction (Type 1 implant placement)
- Need for simultaneous soft tissue augmentation
- Residual bone height greater than 5 mm
- Individuals younger than 21 years old
AI-Screening
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Trial Site Locations
Total: 1 location
1
Medical University of Graz, University Hospital for Dentistry and Oral Health
Graz, Austria, 8010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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