BridgeMD
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
EU CTIS ID: 2024-511366-36-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Medically healthy adult (ASA classification I-II), age ≥ 21 years old
- Non-smoker, previous smoker (quit ≥ 5 years); light smoker with less than 10 cigarettes/ day
- Not allergic to Amoxicillin/Penicillin antibiotics, NSAIDS or corn-starch
- 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).
- Absence of signs of pathology of the sinus membrane and acute sinusitis requiring ongoing management
You likely can't join if
- Medically compromised subjects (ASA classification III-V)
- Type 1 implant placement (immediate implant placement following extraction)
- Need for simultaneous soft tissue augmentation
- Residual bone height of > 5mm.
- Subjects aged < 21 years old
- General contraindications against implant treatment or augmentative procedures (e.g. immunodeficiency, advanced systemic diseases, corticosteroid medication)
See the full eligibility criteria
- Medically healthy adult (ASA classification I-II), age ≥ 21 years old
- Non-smoker, previous smoker (quit ≥ 5 years); light smoker with less than 10 cigarettes/ day
- Not allergic to Amoxicillin/Penicillin antibiotics, NSAIDS or corn-starch
- 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).
- Absence of signs of pathology of the sinus membrane and acute sinusitis requiring ongoing management
- Medically compromised subjects (ASA classification III-V)
- Type 1 implant placement (immediate implant placement following extraction)
- Need for simultaneous soft tissue augmentation
- Residual bone height of > 5mm.
- Subjects aged < 21 years old
- General contraindications against implant treatment or augmentative procedures (e.g. immunodeficiency, advanced systemic diseases, corticosteroid medication)
- Those taking Bisphosphonates/anti-angiogenic/RANKL inhibitor medications or receiving local radio-therapy
- Heavy smoker or previous heavy smoker (quit < 5 years; ≥ 10 cigarettes/day)
- Allergic to Amoxicillin or Penicillin antibiotics, NSAIDS and / or corn starch
- Use of any form of antibiotics in the last 3 months or subjects requiring regular antibiotic prophylaxis prior to dental treatment
- Pregnant or breast feeding. Self-declared intend to conceive (A pregnancy test will be performed for all female patients).
- Need for 2 stage sinus augmentation
- Acute or unmanaged symptomatic sinusitis
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.