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.
Conditions
Interventions
Trade Name: Amoxicilina 500 mg
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Sponsors
Universidad Complutense de Madrid
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Medically compromised subjects (ASA classification III-V) 2. General contraindications against implant treatment or augmentative procedures (e.g. immunodeficiency, advanced systemic diseases, corticosteroid medication) 3. Those taking Bisphosphonates/anti-angiogenic/RANKL inhibitor medications or receiving local radio-therapy 4. Heavy smoker or previous heavy smoker (quit 5mm. 13. Subjects aged < 21 years old
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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).;Primary end point(s): 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);Timepoint(s) of evaluation of this end point: Baseline - 2 weeks after surgery- 4 weeks after surgery- 16 to 20 weeks after surgery- moment of crown installation- 6 months after crown installation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Clinical recordings of post-surgical complications: flap closure/dehiscence, purulent discharge, swelling and implant stability and early implant loss.;Timepoint(s) of evaluation of this end point: Baseline - 2 weeks after surgery- 4 weeks after surgery- 16 to 20 weeks after surgery- moment of crown installation- 6 months after crown installation | — |
Countries
Spain
Contacts
Public ContactMaster de Periodoncia
Universidad Complutense de Madrid
Outcome results
None listed