Amoxicillin for Sinus floor elevation with guided bone regeneration for posterior maxillary implant placement

Inclusion criteria

• {"criterion_text":"- Medically healthy adult (ASA classification I-II), age ≥ 21 years old\n- Non-smoker, previous smoker (quit ≥ 5 years); light smoker with less than 10 cigarettes/ day\n- Not allergic to Amoxicillin/Penicillin antibiotics, NSAIDS or corn-starch\n- 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).\n- Absence of signs of pathology of the sinus membrane and acute sinusitis requiring ongoing management"}

Exclusion criteria

• {"criterion_text":"- Medically compromised subjects (ASA classification III-V)\n- Type 1 implant placement (immediate implant placement following extraction)\n- Need for simultaneous soft tissue augmentation\n- Residual bone height of > 5mm.\n- Subjects aged < 21 years old\n- General contraindications against implant treatment or augmentative procedures (e.g. immunodeficiency, advanced systemic diseases, corticosteroid medication)\n- Those taking Bisphosphonates/anti-angiogenic/RANKL inhibitor medications or receiving local radio-therapy\n- Heavy smoker or previous heavy smoker (quit < 5 years; ≥ 10 cigarettes/day)\n- Allergic to Amoxicillin or Penicillin antibiotics, NSAIDS and / or corn starch\n- Use of any form of antibiotics in the last 3 months or subjects requiring regular antibiotic prophylaxis prior to dental treatment\n- Pregnant or breast feeding. Self-declared intend to conceive (A pregnancy test will be performed for all female patients).\n- Need for 2 stage sinus augmentation\n- Acute or unmanaged symptomatic sinusitis"}

Primary endpoints

• {"endpoint_text":"- 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 .","definition_or_measurement_approach":"Visual analogue scores (VAS 0-10) collected for wound-related symptoms (bleeding, swelling, pain, bruising) and sinus discomfort (nosebleed, nasal congestion, rhinorrhea, feeling of pressure, hyposmia) on days 1-7 and day 14."}

Secondary endpoints

• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Clinical assessments at specified visits (week 2, week 4, weeks 16-20, and 6 months) recording presence/absence and details of flap closure/dehiscence, pain/sensitivity on palpation, swelling, suppuration/purulent discharge, and implant stability (at initial placement and at 2nd stage surgery)."}

Austria

Earliest CTIS Part Ii Submission Date

09-08-2024

Latest Decision Or Authorization Date

08-09-2024

Processing Time Days

30

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

Medical University Of Graz

Organisation Type

Educational Institution

Country Of Registered Address

Austria

Third parties

• {"country":"","full_name":"International Team for Implantology","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"Straumann GmbH","duties_or_roles":"Source of monetary support","organisation_type":""}