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
- Conditions
- implant surgery with guided bone regeneration and simultaneous sinus floor elevation
- Registration Number
- 2024-511366-36-00
- Lead Sponsor
- Medical University Of Graz
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruiting
- Sex
- Not specified
- Target Recruitment
- 30
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient Reported Outcome Measures (PROMs): Visual analogue scores VAS (0-10) on the wound (bleeding, swelling, pain, bruising (haematoma)) and discomfort of the sinuses (nosebleed, nasal congestion, rhinorrhea (excessive nasal discharge including posterior nasal drip), feeling of pressure, hyposmia (reduction in smell)) on days 1-7 & 14 . Patient Reported Outcome Measures (PROMs): Visual analogue scores VAS (0-10) on the wound (bleeding, swelling, pain, bruising (haematoma)) and discomfort of the sinuses (nosebleed, nasal congestion, rhinorrhea (excessive nasal discharge including posterior nasal drip), feeling of pressure, hyposmia (reduction in smell)) on days 1-7 & 14 .
- Secondary Outcome Measures
Name Time Method Clinical recordings of post-surgical complications at week 2, 4, 16-20 and 6 months after crown- installation on: flap closure/dehiscence, pain/sensitivity on palpation, swelling (obliteration of the sulcus), suppuration/purulent discharge, Implant stability (at initial placement and 2nd stage surgery). Clinical recordings of post-surgical complications at week 2, 4, 16-20 and 6 months after crown- installation on: flap closure/dehiscence, pain/sensitivity on palpation, swelling (obliteration of the sulcus), suppuration/purulent discharge, Implant stability (at initial placement and 2nd stage surgery).
Trial Locations
- Locations (1)
Medical University Of Graz
🇦🇹Graz, Austria
Medical University Of Graz🇦🇹Graz, AustriaMichael PayerSite contact031638580659mi.payer@medunigraz.at