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

NCT04552080 | Recruiting Phase 4

• 1 other identifier: Syst AB + Sinus 01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Test: Amoxicillin

ACTIVE COMPARATOR

Drug: Amoxicillin

Comparator: Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Amoxicillin 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.

Test: Amoxicillin

Placebo 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.

Comparator: Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medically healthy adult: ASA (American Society of Anesthesiologists) classification I-II, age ≥ 21 years old
• Non-smoker, previous smoker (quit ≥ 5 years); light smoker with less than 10 cigarettes/ day
• Not allergic to Amoxicillin/Penicillin antibiotics, NSAIDS (Nonsteroidal anti-inflammatory drugs) or corn-starch
• 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).
• Absence of signs of pathology of the sinus membrane and acute sinusitis requiring ongoing management -

You may not qualify if:

• Medically compromised subjects (ASA classification III-V)
• General contraindications against implant treatment or augmentative procedures (e.g. immunodeficiency, advanced systemic diseases, corticosteroid medication)
• Those taking Bisphosphonates/anti-angiogenic/RANKL (Receptor activator of nuclear factor kappa-Β Ligand) inhibitor medications or receiving local radio-therapy
• Heavy smoker or previous heavy smoker (quit \< 5 years; ≥ 10 cigarettes/day)
• Allergic to Amoxicillin or Penicillin antibiotics, NSAIDS and / or corn starch
• Use of any form of antibiotics in the last 3 months or subjects requiring regular antibiotic prophylaxis prior to dental treatment
• Pregnant or breast feeding. Self-declared intend to conceive (A pregnancy test will be performed for all female patients).
• Need for 2 stage sinus augmentation
• Acute or unmanaged symptomatic sinusitis
• Type 1 implant placement (immediate implant placement following extraction)
• Need for simultaneous soft tissue augmentation
• Residual bone height of \> 5mm.
• Subjects aged \< 21 years old

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

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

Graz, 8010, Austria

RECRUITING

MeSH Terms

Interventions

Amoxicillin

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: September 17, 2020
• Study Start: December 29, 2022
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)