NCT04552080

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-12-29
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2020-09-17
• Last updated: 2024-07-03

Locations

1 site across 1 country: Austria