The effect of systemic antibiotics on post-surgical complications and patient-centered outomes in patients undergoing implant surgery with the guided bone regeneration and simultaneous sinus floor elevation.
- Conditions
- The medical condition that the patients have in this trial is edentulism in a posterior maxillary quadrant of the mouth with a sinus pneumatisation/ decreased crestal bone heigh defect requiring augmentation and rehabilitation with 1-3 implants. We want to investigate the effect of amoxicillin after this procedure in terms of complications and patient-centered outcomes.
- Registration Number
- 2025-521185-10-00
- Lead Sponsor
- Complutense University Of Madrid
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised, recruitment pending
- Sex
- Not specified
- Target Recruitment
- 30
- Medically healthy adult (ASA 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 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
Medically compromised subjects (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 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; 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
Study & Design
- Study Type
- Not specified
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient Reported Outcome Measures (PROMs): Visual analogue scores VAS on the wound (pain, swelling, bruising (haematoma), bleeding) and discomfort of the sinuses (nosebleed, nasal congestion, rhinorrhea (excessive nasal discharge including posterior nasal drip), feeling of pressure, hyposmia (reduction in smell) Patient Reported Outcome Measures (PROMs): Visual analogue scores VAS on the wound (pain, swelling, bruising (haematoma), bleeding) and discomfort of the sinuses (nosebleed, nasal congestion, rhinorrhea (excessive nasal discharge including posterior nasal drip), feeling of pressure, hyposmia (reduction in smell)
- Secondary Outcome Measures
Name Time Method Clinical recordings of post-surgical complications: flap closure/dehiscence, purulent discharge, swelling and implant stability and early implant loss. Clinical recordings of post-surgical complications: flap closure/dehiscence, purulent discharge, swelling and implant stability and early implant loss.
Trial Locations
- Locations (1)
Complutense University Of Madrid
🇪🇸Madrid, Spain
Complutense University Of Madrid🇪🇸Madrid, SpainMARIANO SANZSite contact913942021marianosanz@odon.ucm.es