Recruiting

NCT Number: 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

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).

Recruiting

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Key information

Conditions

Patients Undergoing Oral Implant Therapy

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Graz, 8010, Austria

Location status: Recruiting

Location contact

Norbert Jakse, Professor, MD

CONTACT

[email protected]

0043 316 3851 2921

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 -

Exclusion criteria

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

Treatment and study plan

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.

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.

Primary outcomes

Patient-centered Outcomes - 1

Time frame: days 1-7 and 14

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).
Patient-centered Outcomes - 2

Time frame: days 1-7 and 14

Change in discomfort of the sinuses (nosebleed, nasal congestion, rhinorrhea, feeling of pressure, hyposmia)

Sponsors and collaborators

Lead sponsor

Medical University of Graz