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

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).

Study Overview

• Status: Recruiting
• Conditions: Patients Undergoing Oral Implant Therapy
• Intervention / Treatment: Drug: Amoxicillin; Other: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8010
    • Recruiting
    • Medical University of Graz, University Hospital for Dentistry and Oral Health
    • Contact: Norbert Jakse, Professor, MD; Phone Number: 0043 316 3851 2921; Email: norbert.jakse@medunigraz.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Test: Amoxicillin	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.
Placebo Comparator: Comparator: Placebo	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Patient-centered Outcomes - 2	Change in discomfort of the sinuses (nosebleed, nasal congestion, rhinorrhea, feeling of pressure, hyposmia)	days 1-7 and 14

Collaborators and Investigators

• Sponsor: Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2022
• Primary Completion (Anticipated): March 1, 2026
• Study Completion (Anticipated): March 1, 2026

Study Registration Dates

• First Submitted: September 10, 2020
• First Submitted That Met QC Criteria: September 10, 2020
• First Posted (Actual): September 17, 2020

Study Record Updates

• Last Update Posted (Estimate): January 11, 2023
• Last Update Submitted That Met QC Criteria: January 9, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Amoxicillin
• Other Study ID Numbers: Syst AB + Sinus 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No