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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Patients Undergoing Oral Implant Therapy

Intervention / Treatment
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* Drug: Amoxicillin
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Test: Amoxicillin<br> | Drug: Amoxicillin<br>* 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.<br>|
| Placebo Comparator: Comparator: Placebo<br> | Other: Placebo<br>* 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.<br>|

What is the study measuring?
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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 |