patients undergoing oral implant therapy with simultaneous lateral sinus floor elevation and guided bone regeneration (GBR)
Conditions
Interventions
Trade Name: Moxilen
Product Name: Moxilen
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: AMOXICILLIN
CAS Number: 26787-78-0
Concentration unit: mg milligram(s)
Concentration type: equal
Conce
Sponsors
Medizinische Universität Graz, Universitätsklinik für Zahn-, Mund- und Kieferheilkunde
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 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: 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 < 5 years; = 10 cigarettes/day) 5. Allergic to Amoxicillin or Penicillin antibiotics, NSAIDS and / or corn starch 6. Use of any form of antibiotics in the last 3 months or subjects requiring regular antibiotic prophylaxis prior to dental treatment 7. Pregnant or breast feeding. Self-declared intend to conceive (A pregnancy test will be performed for all female patients). 8. Need for 2 stage sinus augmentation 9. Acute or unmanaged symptomatic sinusitis
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: days 1-7, 14 | — |
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: week 2, 4, 16-20 and 6 months after crown- installation | — |
Countries
Austria
Contacts
Public ContactDept. of Oral Surgery & Radiology
PD. DDr. Michael Payer
Outcome results
None listed