The effect of systemic antibiotics on post-surgical complications and patient-centered outcomes in patients undergoing implant surgery with guided bone regeneration and simultaneous sinus floor elevatio

Phase 1

• Conditions: patients undergoing oral implant therapy with simultaneous lateral sinus floor elevation and guided bone regeneration (GBR); Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Dentistry [E06]

• Registration Number: EUCTR2020-001939-27-AT
• Lead Sponsor: Medizinische Universität Graz, Universitätsklinik für Zahn-, Mund- und Kieferheilkunde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-11
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified