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 Elevation

NCT ID: NCT04552080

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-29
• Study Completion Date: 2026-03-31

Brief 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).

Conditions

Patients Undergoing Oral Implant Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Test: Amoxicillin

Group Type: ACTIVE_COMPARATOR

Amoxicillin

Intervention Type: DRUG

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.

Comparator: Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Eligibility Criteria

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-Β 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical University of Graz, University Hospital for Dentistry and Oral Health

Graz, , Austria

Site Status: RECRUITING

Countries

Austria

Facility Contacts

Norbert Jakse, Professor, MD

Role: primary

norbert.jakse@medunigraz.at

0043 316 3851 2921

Other Identifiers

Syst AB + Sinus 01

Identifier Type: -

Identifier Source: org_study_id