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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04552080
Other study ID # Syst AB + Sinus 01
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date December 29, 2022
Est. completion date March 2026

Study information

Verified date January 2023
Source Medical University of Graz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary aim of the trial is 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. The secondary aims of the trial is 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date March 2026
Est. primary completion date March 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria: 1. Medically healthy adult: ASA (American Society of Anesthesiologists) 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 (Nonsteroidal anti-inflammatory drugs) 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 - 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 (Receptor activator of nuclear factor kappa-? Ligand) 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 10. Type 1 implant placement (immediate implant placement following extraction) 11. Need for simultaneous soft tissue augmentation 12. Residual bone height of > 5mm. 13. Subjects aged < 21 years old

Study Design


Related Conditions & MeSH terms

  • Patients Undergoing Oral Implant Therapy

Intervention

Drug:
Amoxicillin
Preoperatively antibiotics of 2 g amoxicillin 1 hour prior to standard implant placement and sinus floor Elevation will be administered. An additional single dose of 500 mg of amoxicillin will be administered 8 hours after surgery and 500 mg thrice daily (8 hourly) on days 1 to 3 following implant placement and sinus floor elevation.
Other:
Placebo
Preoperatively a placebo of 2 g will be administered. An additional single dose of 500 mg of placebo will be administered 8 hours after surgery and 500 mg thrice daily (8 hourly) on days 1 to 3 following implant placement and sinus floor elevation.

Locations

Country Name City State
Austria Medical University of Graz, University Hospital for Dentistry and Oral Health Graz

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient-centered Outcomes - 1 Change in visual analogue scores (VAS) on the wound (pain, swelling, bruising, haematoma, bleeding) Intensity of bleeding, swelling, pain and bruising on a score from 1(mild) to 10(severe). days 1-7 and 14
Primary Patient-centered Outcomes - 2 Change in discomfort of the sinuses (nosebleed, nasal congestion, rhinorrhea, feeling of pressure, hyposmia) days 1-7 and 14