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

Medical University Of Graz1 site in 1 country30 target enrollmentSeptember 8, 2024

DrugsAmylium Maydis Moxilen 500 mg hard capsules

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Not specified
Sponsor: Medical University Of Graz
Enrollment: 30
Locations: 1
Primary Endpoint: Patient Reported Outcome Measures (PROMs): Visual analogue scores VAS (0-10) on the wound (bleeding, swelling, pain, bruising (haematoma)) and discomfort of the sinuses (nosebleed, nasal congestion, rhinorrhea (excessive nasal discharge including posterior nasal drip), feeling of pressure, hyposmia (reduction in smell)) on days 1-7 & 14 .
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

euclinicaltrials.eu

Start Date

September 8, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Medical University Of Graz

Responsible Party

Principal Investigator

Assoz.-Prof. PD DDr. Michael Payer

Scientific

Medical University Of Graz

Eligibility Criteria

Inclusion Criteria

•Medically healthy adult (ASA 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 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)
•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
•General contraindications against implant treatment or augmentative procedures (e.g. immunodeficiency, advanced systemic diseases, corticosteroid medication)
•Those taking Bisphosphonates/anti-angiogenic/RANKL 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

Outcomes

Primary Outcomes

Patient Reported Outcome Measures (PROMs): Visual analogue scores VAS (0-10) on the wound (bleeding, swelling, pain, bruising (haematoma)) and discomfort of the sinuses (nosebleed, nasal congestion, rhinorrhea (excessive nasal discharge including posterior nasal drip), feeling of pressure, hyposmia (reduction in smell)) on days 1-7 & 14 .

Secondary Outcomes

Clinical recordings of post-surgical complications at week 2, 4, 16-20 and 6 months after crown- installation on: flap closure/dehiscence, pain/sensitivity on palpation, swelling (obliteration of the sulcus), suppuration/purulent discharge, Implant stability (at initial placement and 2nd stage surgery).