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New treatment option for Patients Undergoing Oral Implant Therapy
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
ClinicalTrials.gov ID: NCT04552080
What this study is testing
What is Amoxicillin?
Amoxicillin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for patients undergoing oral implant therapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older. Healthy volunteers may be eligible.
You may be able to join if
- Medically healthy adult: ASA (American Society of Anesthesiologists) 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 (Nonsteroidal anti-inflammatory drugs) 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...
- Absence of signs of pathology of the sinus membrane and acute sinusitis requiring ongoing management -
You likely can't join if
- Medically compromised people (ASA classification III-V)
- General contraindications against implant treatment or augmentative procedures (e.g. immunodeficiency, advanced systemic diseases, corticosteroid...
- Those taking Bisphosphonates/anti-angiogenic/RANKL (Receptor activator of nuclear factor kappa-Β Ligand) inhibitor medications or receiving local...
- 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 people requiring regular antibiotic prophylaxis prior to dental treatment
See the full eligibility criteria
- Medically healthy adult: ASA (American Society of Anesthesiologists) 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 (Nonsteroidal anti-inflammatory drugs) 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...
- Absence of signs of pathology of the sinus membrane and acute sinusitis requiring ongoing management -
- Medically compromised people (ASA classification III-V)
- General contraindications against implant treatment or augmentative procedures (e.g. immunodeficiency, advanced systemic diseases, corticosteroid medication)
- Those taking Bisphosphonates/anti-angiogenic/RANKL (Receptor activator of nuclear factor kappa-Β Ligand) 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 people 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
- Type 1 implant placement (immediate implant placement following extraction)
- Need for simultaneous soft tissue augmentation
- Residual bone height of \> 5mm.
- people aged \< 21 years old
The study team makes the final eligibility decision.
Where it's taking place
- Graz, Austria
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, 21 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Graz, Austria. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.